<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04446377</url>
  </required_header>
  <id_info>
    <org_study_id>LAM-002A-CVD-CLN01</org_study_id>
    <nct_id>NCT04446377</nct_id>
  </id_info>
  <brief_title>A Study of LAM-002A for the Prevention of Progression of COVID-19</brief_title>
  <official_title>A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AI Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AI Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment&#xD;
      in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care&#xD;
      in an outpatient setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II randomized, double-blind, placebo-controlled, clinical study to evaluate&#xD;
      the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2&#xD;
      infection who are receiving standard supportive care in an outpatient setting.&#xD;
&#xD;
      Study eligibility will be assessed during screening. All study participants must sign a&#xD;
      written informed consent and satisfy the inclusion and exclusion criteria for the study.&#xD;
      Confirmation of SARS-CoV-2 infection, medical history, and current medication will be&#xD;
      assessed for each consenting participant at screening.&#xD;
&#xD;
      Study participants will be randomized in a 1:1 ratio, to receive study therapy (either&#xD;
      LAM-002A, 125 mg [5 capsules/dose]) PO BID or placebo [5 capsules/dose] PO BID) for 10 days.&#xD;
      Participants who experience an adverse event (AE) considered to be related to study therapy&#xD;
      may have a decrease in study dose of LAM-002A to 100 mg [4 capsules/dose]) PO BID or placebo&#xD;
      [4 capsules/dose] PO BID). After the start of treatment on Day 1, participants will be&#xD;
      followed at Days 4,6,8,11,22, and 28. Days 6,8, and 22 will be phone visits. Participants can&#xD;
      withdraw from the study therapy or study participation at any time.&#xD;
&#xD;
      The study will incorporate an interim safety analysis after the first 30 participants (15 on&#xD;
      LAM-002A and 15 on placebo) have completed treatment and have been followed up for 11 days&#xD;
      post-first dose. Recruitment and randomization will continue while this analysis is&#xD;
      conducted. Recommendations from an independent Data Safety Monitoring Board (DSMB) will be&#xD;
      used for decisions of early termination or study design adaptations.&#xD;
&#xD;
      Non-parametric and parametric statistical analysis will be conducted, as appropriate. For the&#xD;
      comparison of the LAM-002A active arm and the control arm for the primary endpoint and&#xD;
      secondary endpoints of drug effect, appropriate methods will be employed. Baseline subject&#xD;
      characteristics, study therapy administration/compliance, safety, supportive care&#xD;
      administration, and pharmacokinetics will be analyzed descriptively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">April 19, 2021</completion_date>
  <primary_completion_date type="Actual">March 24, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Viral Load Change</measure>
    <time_frame>4 Days</time_frame>
    <description>The primary efficacy outcome measure evaluated change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load was measured by a real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) test of nasopharyngeal samples. Analysis focused on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load &gt;100,000 copies/mL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>28 Days</time_frame>
    <description>The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Efficacy</measure>
    <time_frame>28 Days</time_frame>
    <description>Number of Participants with Hospitalization or Death within 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in COVID-19 Clinical Status</measure>
    <time_frame>28 Days</time_frame>
    <description>To evaluate change in COVID-19 clinical status, as defined by the ordinal scale, of participants treated with LAM-002A compared to placebo at Day 28, in participants who became hospitalized and continued LAM-002A/placebo treatment, based on the following scores:&#xD;
Not in the hospital&#xD;
Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)&#xD;
Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)&#xD;
Hospitalized, in the ICU, on invasive ventilation or Extracorporeal membrane oxygenation (ECMO)&#xD;
Dead</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>Baseline, Day 1, Day 4, Day 11, Day28</time_frame>
    <description>Comparison of the number and percentage of participants with an oxygen saturation (O2 sat) ≥95% between LAM-002A versus placebo treatment groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number and Percentage of Participants With Viral Load &lt; Lower Limit of Quantification (LLOQ)</measure>
    <time_frame>4 Days</time_frame>
    <description>Evaluated the difference in the number and percentage of participants with a SARS-CoV-2 viral load &lt;LLOQ between the LAM-002A and the placebo arm as measured by a qRT-PCR test from nasopharyngeal samples at Day 4.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>COVID-19 Disease</condition>
  <arm_group>
    <arm_group_label>LAM-002A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LAM-002A (Apilimod Dimesylate) 125mg in five 25-mg capsules BID for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>(microcrystalline cellulose) in 5 capsules BID for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apilimod Dimesylate Capsule</intervention_name>
    <description>LAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0.</description>
    <arm_group_label>LAM-002A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Microcrystalline cellulose in Swedish orange, Size 0 capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written documentation of SARS-CoV-2 infection confirmed by a validated test.&#xD;
&#xD;
          2. Presence of greater than or equal to ≥1 of the following COVID-19-related symptoms&#xD;
             indicating mild disease: fever (temperature ≥100.4), anosmia (loss of taste or smell),&#xD;
             cough, sore throat, gastrointestinal complaints (e.g. nausea, vomiting, or diarrhea),&#xD;
             chills, congestion, or runny nose, headaches, muscle or body aches, fatigue, or&#xD;
             asymptomatic patients who have tested positive for COVID-19 via a validated test&#xD;
             within the past 4 days.&#xD;
&#xD;
          3. If symptomatic, symptom onset less than or equal to ≤ 8 days.&#xD;
&#xD;
          4. For female participants of childbearing potential, a negative urine (or serum)&#xD;
             pregnancy test.&#xD;
&#xD;
          5. For female participants of childbearing potential, willingness to use a&#xD;
             protocol-recommended method of contraception from the start of the screening period&#xD;
             until greater than or equal to ≥30 days after the final dose of study therapy. Note: A&#xD;
             female subject is considered to be of childbearing potential unless she has had a&#xD;
             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically&#xD;
             documented ovarian failure (with serum estradiol and follicle-stimulating hormone&#xD;
             [FSH] levels within the institutional laboratory postmenopausal range and a negative&#xD;
             serum or urine beta human chorionic gonadotropin [βHCG]); or is menopausal (age ≥50&#xD;
             years with amenorrhea for ≥6 months).&#xD;
&#xD;
          6. For male participants who can father a child and are having intercourse with females&#xD;
             of childbearing potential who are not using adequate contraception, willingness to use&#xD;
             a protocol-recommended method of contraception from the start of study therapy until&#xD;
             ≥30 days after the final dose of study therapy and to refrain from sperm donation from&#xD;
             the start of study therapy until ≥90 days after administration of the final dose of&#xD;
             study therapy. Note: A male subject is considered able to father a child unless he has&#xD;
             had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy.&#xD;
&#xD;
          7. Willingness and ability of the participant to ingest study drug capsules.&#xD;
&#xD;
          8. Willingness of the participant to comply with scheduled visits, drug administration&#xD;
             plan, protocol-specified laboratory tests, study procedures, and study restrictions.&#xD;
&#xD;
          9. Evidence of a personally signed informed consent indicating that the participant is&#xD;
             aware of the nature of the disease and has been informed of the procedures to be&#xD;
             followed, the experimental nature of the therapy, alternatives, potential risks and&#xD;
             discomforts, potential benefits, and other pertinent aspects of study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Respiratory rate greater than or equal to ≥20 breaths per minute.&#xD;
&#xD;
          2. Oxygen saturation by pulse oximetry less than or equal to ≤93 percent % on room air or&#xD;
             requirement for supplemental oxygen to maintain oxygen saturation greater than &gt;93&#xD;
             percent %.&#xD;
&#xD;
          3. Total NEWS score greater than or equal to ≥6 or presence of a score of 3 on any of the&#xD;
             individual NEWS parameters.&#xD;
&#xD;
          4. Radiographic evidence of pulmonary infiltrates (clinical X-ray within 2 days of&#xD;
             referral)&#xD;
&#xD;
          5. Hepatic profile showing any of the following:&#xD;
&#xD;
               -  Serum alanine aminotransferase (ALT) greater than &gt;5 × upper limit of normal&#xD;
                  (ULN) (CTCAE Grade greater than or equal to ≥3).&#xD;
&#xD;
               -  Serum aspartate aminotransferase (AST) greater than &gt;5 × ULN (CTCAE Grade greater&#xD;
                  than or equal to ≥3).&#xD;
&#xD;
               -  Serum bilirubin greater than &gt;1.5 × ULN (CTCAE Grade greater than or equal to&#xD;
                  ≥2).&#xD;
&#xD;
          6. Renal profile showing an estimated creatinine clearance (eClCR) less than &lt;30&#xD;
             mL/minute (with eClCR to be calculated by the method at the laboratory performing the&#xD;
             serum creatinine test).&#xD;
&#xD;
          7. Presence of a cancer with disease manifestations or therapy that could adversely&#xD;
             affect subject safety or longevity, create the potential for drug-drug interactions,&#xD;
             or compromise the interpretation of study results.&#xD;
&#xD;
          8. Significant cardiovascular disease (e.g. myocardial infarction, arterial&#xD;
             thromboembolism, cerebrovascular thromboembolism) within 1 month prior to start of&#xD;
             study therapy; unstable angina; symptomatic peripheral vascular disease; CTCAE Grade&#xD;
             greater than or equal to ≥2 congestive heart failure; or uncontrolled CTCAE Grade&#xD;
             greater than or equal to ≥3 hypertension (diastolic blood pressure greater than or&#xD;
             equal to ≥100 mmHg or systolic blood pressure greater than or equal to ≥160 mmHg)&#xD;
             despite antihypertensive therapy.&#xD;
&#xD;
          9. Significant screening ECG abnormalities, including atrial fibrillation/flutter, 2nd&#xD;
             degree atrioventricular (AV) block type II, 3rd-degree AV block, Grade greater than or&#xD;
             equal to ≥2 bradycardia, or corrected QT (QTc by Fridericia [QTcF]) greater than &gt;480&#xD;
             msec (Grade greater than &gt;1).&#xD;
&#xD;
         10. Gastrointestinal disease (e.g. gastric or intestinal bypass surgery, pancreatic enzyme&#xD;
             insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic&#xD;
             diarrheal illness, bowel obstruction) that might interfere with drug absorption or&#xD;
             with interpretation of gastrointestinal AEs.&#xD;
&#xD;
         11. Pregnancy or breastfeeding.&#xD;
&#xD;
         12. Prior solid organ transplantation.&#xD;
&#xD;
         13. Use within 5 days prior to randomization of an approved or investigational therapy&#xD;
             intended to treat COVID-19 (e.g. remdesivir, , anti-interleukin [IL]-6 antibodies,&#xD;
             therapeutic anti-SARS CoV-2 antibodies or post-convalescent plasma, anti- SARS CoV-2&#xD;
             vaccine, Bruton tyrosine kinase [BTK] inhibitor), use within 3 months of chloroquine&#xD;
             or hydroxychloroquine. Note: participants are not precluded from undergoing&#xD;
             evaluations involving observation, noninvasive diagnostic procedures or sampling, or&#xD;
             questionnaires as follow-up to a prior study or as components of a concurrent&#xD;
             noninterventional study.&#xD;
&#xD;
         14. Use within 5 days prior to randomization of a strong inhibitor or inducer of&#xD;
             cytochrome P450 (CYP) 3A4 or expected requirement for chronic use of a strong&#xD;
             inhibitor or inducer of CYP3A4 during study therapy.&#xD;
&#xD;
         15. Use within 5 days prior to randomization of drug that is a moderate-to-strong&#xD;
             substrate of CYP2C9 (including warfarin, tolbutamide, phenytoin, glimepiride) or&#xD;
             expected requirement for chronic use of such drugs during study therapy.&#xD;
&#xD;
         16. Use within 5 days prior to randomization of a drug known to prolong the QT interval&#xD;
&#xD;
         17. Ongoing immunosuppressive therapy including systemic or enteric corticosteroids.&#xD;
             (Note: At study entry, participants may be using intraarticular, inhaled, or topical&#xD;
             corticosteroids. During study therapy, participants may use systemic, enteric,&#xD;
             intraarticular, inhaled, or topical corticosteroids as required for intercurrent&#xD;
             conditions.)&#xD;
&#xD;
         18. Any illness, medical condition, organ system dysfunction, or social situation,&#xD;
             including mental illness or substance abuse, deemed by the investigator to be likely&#xD;
             to interfere with a participant's ability to provide informed consent, adversely&#xD;
             affect the participant's ability to cooperate and participate in the study, or&#xD;
             compromise the interpretation of study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <results_first_submitted>May 19, 2023</results_first_submitted>
  <results_first_submitted_qc>August 4, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2023</results_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Apilimod Dimesylate</keyword>
  <keyword>LAM-002A</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>AI Therapeutics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT04446377/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted by 8 investigators located at medical centers throughout the United States</recruitment_details>
      <pre_assignment_details>The screening and baseline visits could occur on the same day. Day 1 of the study was the day the participant took the first dose of study drug after randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LAM-002A</title>
          <description>71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules twice a day (BID) for 10 days.&#xD;
Participants were to be followed for 28 days from the start of LAM-002A treatment.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.&#xD;
Participants were to be followed for 28 days from the start of Placebo treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not eligible</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>LAM-002A</title>
          <description>71 subjects were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>71 subjects were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="71"/>
            <count group_id="B2" value="71"/>
            <count group_id="B3" value="142"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.8" lower_limit="18.7" upper_limit="70.4"/>
                    <measurement group_id="B2" value="43.3" lower_limit="18.5" upper_limit="65.7"/>
                    <measurement group_id="B3" value="43.1" lower_limit="18.5" upper_limit="70.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Patient Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG Performance Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0: Fully active</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1: Restricted</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2: Ambulatory</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Oxygen Saturation</title>
          <units>percent</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98.0" lower_limit="95.0" upper_limit="100.0"/>
                    <measurement group_id="B2" value="98.0" lower_limit="95.0" upper_limit="100.0"/>
                    <measurement group_id="B3" value="98.0" lower_limit="95.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Temperature</title>
          <units>degrees Celsius</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.8" lower_limit="35.7" upper_limit="38.6"/>
                    <measurement group_id="B2" value="36.8" lower_limit="35.6" upper_limit="38.0"/>
                    <measurement group_id="B3" value="36.8" lower_limit="35.6" upper_limit="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Viral Load Change</title>
        <description>The primary efficacy outcome measure evaluated change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load was measured by a real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) test of nasopharyngeal samples. Analysis focused on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load &gt;100,000 copies/mL</description>
        <time_frame>4 Days</time_frame>
        <population>Antiviral efficacy population comprising of participants with baseline viral load &gt;100,000 copies/mL = log10 viral load &gt;5)</population>
        <group_list>
          <group group_id="O1">
            <title>LAM-002A</title>
            <description>71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Load Change</title>
          <description>The primary efficacy outcome measure evaluated change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load was measured by a real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) test of nasopharyngeal samples. Analysis focused on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load &gt;100,000 copies/mL</description>
          <population>Antiviral efficacy population comprising of participants with baseline viral load &gt;100,000 copies/mL = log10 viral load &gt;5)</population>
          <units>log10 copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.50" spread="2.35"/>
                    <measurement group_id="O2" value="-1.99" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The analysis tested whether the viral load in nasopharyngeal samples was lower at Day 4 in those receiving LAM-002A compared to Placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The alternative hypothesis for the statistical testing was that LAM-002A would induce greater changes in viral load from Day 1 to Day 4 than would Placebo.</non_inferiority_desc>
            <p_value>0.35</p_value>
            <p_value_desc>Pre-specified 2-sided significance level of 0.20</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>ANCOVA linear mixed model to evaluate the relative differences between the LAM-002A and Placebo groups in the log10 viral load from Day 1 to Day 4.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.47</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>The difference between the groups (LAM-002A vs Placebo).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo</description>
        <time_frame>28 Days</time_frame>
        <population>All participants who received at least 1 dose of study treatment</population>
        <group_list>
          <group group_id="O1">
            <title>LAM-002A</title>
            <description>71 participants received LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>70 participants received Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo</description>
          <population>All participants who received at least 1 dose of study treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Efficacy</title>
        <description>Number of Participants with Hospitalization or Death within 28 days</description>
        <time_frame>28 Days</time_frame>
        <population>The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>LAM-002A</title>
            <description>71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>71participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Efficacy</title>
          <description>Number of Participants with Hospitalization or Death within 28 days</description>
          <population>The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The alternative hypothesis for the statistical testing was that LAM-002A would reduce the cumulative rate of hospitalization or death during the 28-day period comprising 10 days of study drug administration and a further 18 days of observation.</non_inferiority_desc>
            <p_value>0.55</p_value>
            <method>Log Rank</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>22.89</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in COVID-19 Clinical Status</title>
        <description>To evaluate change in COVID-19 clinical status, as defined by the ordinal scale, of participants treated with LAM-002A compared to placebo at Day 28, in participants who became hospitalized and continued LAM-002A/placebo treatment, based on the following scores:&#xD;
Not in the hospital&#xD;
Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)&#xD;
Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)&#xD;
Hospitalized, in the ICU, on invasive ventilation or Extracorporeal membrane oxygenation (ECMO)&#xD;
Dead</description>
        <time_frame>28 Days</time_frame>
        <population>The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.&#xD;
* Participant 008-109 in the LAM-002A group was in the hospital at Day 28, but her score is missing, this participant died in the hospital on Day 30.</population>
        <group_list>
          <group group_id="O1">
            <title>LAM-002A</title>
            <description>71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in COVID-19 Clinical Status</title>
          <description>To evaluate change in COVID-19 clinical status, as defined by the ordinal scale, of participants treated with LAM-002A compared to placebo at Day 28, in participants who became hospitalized and continued LAM-002A/placebo treatment, based on the following scores:&#xD;
Not in the hospital&#xD;
Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)&#xD;
Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)&#xD;
Hospitalized, in the ICU, on invasive ventilation or Extracorporeal membrane oxygenation (ECMO)&#xD;
Dead</description>
          <population>The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.&#xD;
* Participant 008-109 in the LAM-002A group was in the hospital at Day 28, but her score is missing, this participant died in the hospital on Day 30.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1: Not in the hospital</title>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2: Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3: Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4: Hospitalized, in the ICU, on invasive ventilation or ECMO</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5: Dead</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Status Unknown*</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oxygen Saturation</title>
        <description>Comparison of the number and percentage of participants with an oxygen saturation (O2 sat) ≥95% between LAM-002A versus placebo treatment groups.</description>
        <time_frame>Baseline, Day 1, Day 4, Day 11, Day28</time_frame>
        <population>The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>LAM-002A</title>
            <description>71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.nge, Size 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Saturation</title>
          <description>Comparison of the number and percentage of participants with an oxygen saturation (O2 sat) ≥95% between LAM-002A versus placebo treatment groups.</description>
          <population>The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, oxygen saturation ≥95%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, oxygen saturation ≥95%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4, oxygen saturation ≥95%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11, oxygen saturation ≥95%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, oxygen saturation ≥95%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Risk Difference from generalized estimating equations (GEE) logistic regression at Baseline</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-1.4</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Risk Difference from GEE Logistic Regression at Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-1.0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Risk Difference from GEE logistic regression at Day 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-8.8</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Risk Difference from GEE logistic regression at Day 11</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-3.7</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Percentage of Participants With Viral Load &lt; Lower Limit of Quantification (LLOQ)</title>
        <description>Evaluated the difference in the number and percentage of participants with a SARS-CoV-2 viral load &lt;LLOQ between the LAM-002A and the placebo arm as measured by a qRT-PCR test from nasopharyngeal samples at Day 4.</description>
        <time_frame>4 Days</time_frame>
        <population>Antiviral efficacy population comprising participants with baseline viral load &gt;100,000 copies/ml = log10 viral load &gt;5)</population>
        <group_list>
          <group group_id="O1">
            <title>LAM-002A</title>
            <description>71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Participants With Viral Load &lt; Lower Limit of Quantification (LLOQ)</title>
          <description>Evaluated the difference in the number and percentage of participants with a SARS-CoV-2 viral load &lt;LLOQ between the LAM-002A and the placebo arm as measured by a qRT-PCR test from nasopharyngeal samples at Day 4.</description>
          <population>Antiviral efficacy population comprising participants with baseline viral load &gt;100,000 copies/ml = log10 viral load &gt;5)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The alternative hypothesis for the statistical testing was that, relative to Placebo, LAM-002A would result in a greater proportion of participants with a SARS-CoV-2 viral load &lt;LLOQ on Day 4.</non_inferiority_desc>
            <p_value>0.20</p_value>
            <p_value_desc>Prespecified significance level of 0.20.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Relative Risk</param_type>
            <param_value>2.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>8.48</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the first administration of study drug through Day 28 or when any ongoing drug-related adverse events (AEs) and/or serious adverse events (SAEs) resolved or became stable, up to 30 days.</time_frame>
      <desc>Adverse Events were analyzed for all participants who received at least 1 dose of study treatment. In the Placebo group, 1 subject did not initiate treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>LAM-002A</title>
          <description>71 participants received LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>70 participants received Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 23</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 23</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Respiratory rate increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Initial insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator agreed that the primary publication, will be coordinated by the sponsor, will be the first publication to present the pooled study results. After the primary publication, or if the primary publication is not published within 2 years of termination of the study, the investigator may freely publish or present the results of his or her work conducted under the clinical trial agreement, subject to providing the sponsor with the opportunity to review the contents.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was potentially limited in its ability to discern a benefit of LAM-002A on viral and clinical endpoints due to the number of participants enrolled, the low baseline viral loads, and the short (4-day) duration of viral load evaluation.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Peter R. Young/Chief Scientific Officer</name_or_title>
      <organization>AI Therapeutics</organization>
      <phone>203-458-7100</phone>
      <email>pyoung@ai-thera.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04446377
org study id: LAM-002A-CVD-CLN01
nct id: NCT04446377
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment
      in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care
      in an outpatient setting.
This is a Phase II randomized, double-blind, placebo-controlled, clinical study to evaluate
      the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2
      infection who are receiving standard supportive care in an outpatient setting.

      Study eligibility will be assessed during screening. All study participants must sign a
      written informed consent and satisfy the inclusion and exclusion criteria for the study.
      Confirmation of SARS-CoV-2 infection, medical history, and current medication will be
      assessed for each consenting participant at screening.

      Study participants will be randomized in a 1:1 ratio, to receive study therapy (either
      LAM-002A, 125 mg [5 capsules/dose]) PO BID or placebo [5 capsules/dose] PO BID) for 10 days.
      Participants who experience an adverse event (AE) considered to be related to study therapy
      may have a decrease in study dose of LAM-002A to 100 mg [4 capsules/dose]) PO BID or placebo
      [4 capsules/dose] PO BID). After the start of treatment on Day 1, participants will be
      followed at Days 4,6,8,11,22, and 28. Days 6,8, and 22 will be phone visits. Participants can
      withdraw from the study therapy or study participation at any time.

      The study will incorporate an interim safety analysis after the first 30 participants (15 on
      LAM-002A and 15 on placebo) have completed treatment and have been followed up for 11 days
      post-first dose. Recruitment and randomization will continue while this analysis is
      conducted. Recommendations from an independent Data Safety Monitoring Board (DSMB) will be
      used for decisions of early termination or study design adaptations.

      Non-parametric and parametric statistical analysis will be conducted, as appropriate. For the
      comparison of the LAM-002A active arm and the control arm for the primary endpoint and
      secondary endpoints of drug effect, appropriate methods will be employed. Baseline subject
      characteristics, study therapy administration/compliance, safety, supportive care
      administration, and pharmacokinetics will be analyzed descriptively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blinded
measure: Viral Load Change
time frame: 4 Days
description: The primary efficacy outcome measure evaluated change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load was measured by a real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) test of nasopharyngeal samples. Analysis focused on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load >100,000 copies/mL
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: 28 Days
description: The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo
measure: Clinical Efficacy
time frame: 28 Days
description: Number of Participants with Hospitalization or Death within 28 days
measure: Change in COVID-19 Clinical Status
time frame: 28 Days
description: To evaluate change in COVID-19 clinical status, as defined by the ordinal scale, of participants treated with LAM-002A compared to placebo at Day 28, in participants who became hospitalized and continued LAM-002A/placebo treatment, based on the following scores:
Not in the hospital
Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)
Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)
Hospitalized, in the ICU, on invasive ventilation or Extracorporeal membrane oxygenation (ECMO)
Dead
measure: Oxygen Saturation
time frame: Baseline, Day 1, Day 4, Day 11, Day28
description: Comparison of the number and percentage of participants with an oxygen saturation (O2 sat) ≥95% between LAM-002A versus placebo treatment groups.
measure: Number and Percentage of Participants With Viral Load < Lower Limit of Quantification (LLOQ)
time frame: 4 Days
description: Evaluated the difference in the number and percentage of participants with a SARS-CoV-2 viral load <LLOQ between the LAM-002A and the placebo arm as measured by a qRT-PCR test from nasopharyngeal samples at Day 4.
arm group label: LAM-002A
arm group type: Experimental
description: LAM-002A (Apilimod Dimesylate) 125mg in five 25-mg capsules BID for 10 days
arm group label: Placebo
arm group type: Placebo Comparator
description: (microcrystalline cellulose) in 5 capsules BID for 10 days
intervention type: Drug
intervention name: Apilimod Dimesylate Capsule
description: LAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0.
arm group label: LAM-002A
intervention type: Other
intervention name: Placebo
description: Microcrystalline cellulose in Swedish orange, Size 0 capsules
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was potentially limited in its ability to discern a benefit of LAM-002A on viral and clinical endpoints due to the number of participants enrolled, the low baseline viral loads, and the short (4-day) duration of viral load evaluation.
point of contact: 