<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/NCT04442230</url>
  </required_header>
  <id_info>
    <org_study_id>ALT-601-201</org_study_id>
    <nct_id>NCT04442230</nct_id>
  </id_info>
  <brief_title>NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)</brief_title>
  <official_title>Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Altimmune, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Altimmune, 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>
      The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in&#xD;
      preventing worsening of symptoms and hospitalization in patients with early COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and potential risks, all patient volunteers that have&#xD;
      given written informed consent will undergo screening to determine eligibility for study&#xD;
      entry. If the patient qualifies for the study, they will be randomized in a double-blind&#xD;
      manner in a 1:1 ratio to receive NasoVAX or placebo. On the same day of qualifying into the&#xD;
      study, the patient will be administered the investigational drug (either NasoVAX or placebo).&#xD;
&#xD;
      The patient will return home for the remainder of the study. During this period, the patient&#xD;
      will be monitored remotely by the study center for clinical status. The patient will also be&#xD;
      contacted by study center personnel by telephone to ask about use of any medications and&#xD;
      changes in health including information about any hospitalization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">October 10, 2020</start_date>
  <completion_date type="Actual">February 15, 2021</completion_date>
  <primary_completion_date type="Actual">February 15, 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>Double (Participant, Investigator)</masking>
    <masking_description>Double-Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With Clinical Worsening</measure>
    <time_frame>Day 1 to Day 14</time_frame>
    <description>Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal Severity of COVID-19 After Treatment</measure>
    <time_frame>Day 1 to Day 42</time_frame>
    <description>Percentage of patients requiring hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>Day 1 to Day 42</time_frame>
    <description>All-cause mortality through Day 42</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Coronavirus Infection</condition>
  <arm_group>
    <arm_group_label>NasoVAX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NasoVAX</intervention_name>
    <description>NasoVAX consists of replication-deficient adenovirus vectors in suspension</description>
    <arm_group_label>NasoVAX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able and willing to provide informed consent (Patients themselves must provide written&#xD;
             informed consent before the performance of any study-related procedures, and surrogate&#xD;
             consent by family members, designated legal representatives or caregivers will not be&#xD;
             permitted).&#xD;
&#xD;
          2. Men and women 18 years of age and older&#xD;
&#xD;
          3. Early COVID-19, defined as one or more symptom(s) of fever (oral temperature ≥ 100.4&#xD;
             degrees F), cough, or shortness of breath, onset of these symptoms within 72 hours of&#xD;
             screening, and confirmation of SARS-CoV-2 infection by a polymerase chain reaction&#xD;
             (PCR)-based or rapid antigen diagnostic.&#xD;
&#xD;
          4. Resting SpO2 ≥ 96.0% on room air on two successive measurements&#xD;
&#xD;
          5. For women of childbearing potential (women who are not permanently sterile [documented&#xD;
             hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or&#xD;
             postmenopausal [12 months with no menses without an alternative medical cause])&#xD;
&#xD;
               -  Negative urine pregnancy test at Screening&#xD;
&#xD;
               -  Willingness to practice a highly effective method of contraception that includes,&#xD;
                  but is not limited to, abstinence, sex only with persons of the same sex,&#xD;
                  monogamous relationship with a postmenopausal partner, monogamous relationship&#xD;
                  with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine&#xD;
                  device, or consistent use of a barrier method (eg, condom, diaphragm) with&#xD;
                  spermicide for 28 days after the last dose of study drug&#xD;
&#xD;
          6. For men with sexual partners of childbearing potential, willingness to practice a&#xD;
             highly effective method of contraception, as defined above, for 45 days after the last&#xD;
             dose of study drug&#xD;
&#xD;
          7. Ability and willingness to comply with all aspects of the study, including reliable&#xD;
             internet access, through the entire study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women or planning to conceive a child during the next 3 months&#xD;
&#xD;
          2. Resting respiratory rate &gt;20 breaths/min on room air or resting pulse rate ≥ 125 beats&#xD;
             per minute&#xD;
&#xD;
          3. A rapidly worsening course that in the opinion of the Investigator or treating medical&#xD;
             practitioner would lead to hospitalization within the next 24-48 hours&#xD;
&#xD;
          4. Any chronic pulmonary disease, including chronic obstructive pulmonary disease and&#xD;
             asthma, or other respiratory diseases that could exacerbate independent of COVID-19&#xD;
&#xD;
          5. The following risk factors for severe COVID-19 (Cohorts 1 and 2 only) (Centers for&#xD;
             Disease Control 2020), which based on ongoing review of efficacy and safety data, the&#xD;
             DMC may remove part or all of these risk factors if preliminary data show no signal&#xD;
             for adverse or paradoxical effects:&#xD;
&#xD;
               1. Severe obesity, defined as body mass index ≥ 40 kg/m2&#xD;
&#xD;
               2. History of:&#xD;
&#xD;
                    -  Severe cardiovascular disease, including but not limited to congestive heart&#xD;
                       failure, coronary artery disease, congenital heart disease,&#xD;
                       cardiomyopathies, or pulmonary hypertension&#xD;
&#xD;
                    -  Diabetes mellitus&#xD;
&#xD;
                    -  Chronic or current vaping or cigarette smoking&#xD;
&#xD;
                    -  Chronic kidney disease requiring dialysis&#xD;
&#xD;
                    -  Chronic liver disease, including but not limited to chronic viral hepatitis,&#xD;
                       non-alcoholic steatohepatitis, or cirrhosis of any cause&#xD;
&#xD;
                    -  Hemoglobin disorder, including sickle cell disease and thalassemia&#xD;
&#xD;
          6. History of Bell's Palsy&#xD;
&#xD;
          7. Nasal conditions that might affect the suitability of intranasal medication, such as a&#xD;
             history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or nasal&#xD;
             surgery other than cosmetic rhinoplasty.&#xD;
&#xD;
          8. Use of hydroxychloroquine within the past 4 months, chloroquine with the past 9&#xD;
             months, or other investigational agents for COVID-19 within the past 30 days&#xD;
&#xD;
          9. History of conditions associated with immunocompromise, including but not limited to&#xD;
             poorly controlled HIV, or treatments known to affect the immune system, including but&#xD;
             not limited to oral or intravenous corticosteroids, alkylating drugs, antimetabolites,&#xD;
             cytotoxic drugs, radiation, immune-modulating biologics (including interleukin [IL]-6,&#xD;
             IL-12, Janus kinase inhibitors or antagonists), and cancer treatments, within 30 days&#xD;
             of Screening, or anticipated use within 6 months following participation in this study&#xD;
&#xD;
         10. Any medical, psychiatric, or social condition or occupational or other responsibility&#xD;
             that in the judgment of the Investigator would interfere with or serve as a&#xD;
             contraindication to protocol adherence, assessment of safety (including&#xD;
             reactogenicity), or a patient's ability to give informed consent&#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>Miami Dade Medical Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinite Clinical Trials</name>
      <address>
        <city>Morrow</city>
        <state>Georgia</state>
        <zip>30260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedar Crosse Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Institute for Clinical Research</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Next Level Urgent Care</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <results_first_submitted>February 7, 2022</results_first_submitted>
  <results_first_submitted_qc>March 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2022</results_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04442230/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04442230/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NasoVAX</title>
          <description>Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).&#xD;
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).&#xD;
Placebo: Normal saline</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population</population>
      <group_list>
        <group group_id="B1">
          <title>NasoVAX</title>
          <description>Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).&#xD;
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).&#xD;
Placebo: Normal saline</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="23"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.8" spread="14.05"/>
                    <measurement group_id="B2" value="42.6" spread="14.98"/>
                    <measurement group_id="B3" value="42.2" spread="14.39"/>
                  </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="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </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="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="23"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Risk factors for severe COVID-19</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Risk factors present</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No risk factors present</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Clinical Worsening</title>
        <description>Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements</description>
        <time_frame>Day 1 to Day 14</time_frame>
        <population>Modified intent-to-treat population (all randomized patients who received any amount of study drug and had a Baseline and at least one post-baseline resting SpO2 measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>NasoVAX</title>
            <description>Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).&#xD;
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).&#xD;
Placebo: Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Clinical Worsening</title>
          <description>Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements</description>
          <population>Modified intent-to-treat population (all randomized patients who received any amount of study drug and had a Baseline and at least one post-baseline resting SpO2 measurement)</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="23"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </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 p-values from significance tests were obtained at a one-sided significance level of 0.025.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6602</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximal Severity of COVID-19 After Treatment</title>
        <description>Percentage of patients requiring hospitalization</description>
        <time_frame>Day 1 to Day 42</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NasoVAX</title>
            <description>Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).&#xD;
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).&#xD;
Placebo: Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Maximal Severity of COVID-19 After Treatment</title>
          <description>Percentage of patients requiring hospitalization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Mortality</title>
        <description>All-cause mortality through Day 42</description>
        <time_frame>Day 1 to Day 42</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NasoVAX</title>
            <description>Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).&#xD;
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).&#xD;
Placebo: Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality</title>
          <description>All-cause mortality through Day 42</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NasoVAX</title>
          <description>Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).&#xD;
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).&#xD;
Placebo: Normal saline</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Non-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="22" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="23"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ageusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="25"/>
              </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="12" subjects_affected="9" subjects_at_risk="23"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </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>All information provided regarding the study, as well as all information collected/documented during the course of the study, will be regarded as confidential. The Investigator agrees not to disclose such information in any way without prior written permission from the Sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sarah K. Browne, MD/Senior Director, Clinical Development</name_or_title>
      <organization>Altimmune, Inc.</organization>
      <phone>240-654-1450</phone>
      <email>sbrowne@altimmune.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/NCT04442230
org study id: ALT-601-201
nct id: NCT04442230
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in
      preventing worsening of symptoms and hospitalization in patients with early COVID-19.
After being informed about the study and potential risks, all patient volunteers that have
      given written informed consent will undergo screening to determine eligibility for study
      entry. If the patient qualifies for the study, they will be randomized in a double-blind
      manner in a 1:1 ratio to receive NasoVAX or placebo. On the same day of qualifying into the
      study, the patient will be administered the investigational drug (either NasoVAX or placebo).

      The patient will return home for the remainder of the study. During this period, the patient
      will be monitored remotely by the study center for clinical status. The patient will also be
      contacted by study center personnel by telephone to ask about use of any medications and
      changes in health including information about any hospitalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double-Blind
measure: Percentage of Patients With Clinical Worsening
time frame: Day 1 to Day 14
description: Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements
measure: Maximal Severity of COVID-19 After Treatment
time frame: Day 1 to Day 42
description: Percentage of patients requiring hospitalization
measure: All-cause Mortality
time frame: Day 1 to Day 42
description: All-cause mortality through Day 42
arm group label: NasoVAX
arm group type: Experimental
description: Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
intervention type: Biological
intervention name: NasoVAX
description: NasoVAX consists of replication-deficient adenovirus vectors in suspension
arm group label: NasoVAX
intervention type: Other
intervention name: Placebo
description: Normal saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 