<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/NCT04452565</url>
  </required_header>
  <id_info>
    <org_study_id>NATADEX</org_study_id>
    <nct_id>NCT04452565</nct_id>
  </id_info>
  <brief_title>NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection</brief_title>
  <acronym>NATADEX</acronym>
  <official_title>Randomized Controlled Phase 2/3 Clinical Trial of NA-831 Alone or With Atazanavir, or NA-831 With Dexamethasone, or Atazanavir With Dexamethasone in the Treatment of COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NeuroActiva, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomed Industries, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NeuroActiva, 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized&#xD;
      participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2&#xD;
      infection, in which participants will receive NA-831 or Atazanavir with or without&#xD;
      Dexamethasone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical Phase 2/3 evaluates the safety and efficacy of NA-831 alone, and a combination&#xD;
      therapy comprises NA-831 with an anti-viral drug Atazanavir, NA-831 with an anti-inflammatory&#xD;
      drug, Dexamethasone and a potential synergy between Atazanavir and Dexamethasone. NA-831 is&#xD;
      also known as Traneurocin is a neuroprotective drug that is in clinical study for the&#xD;
      treatment of Alzheimer's Disease. Participants will receive NA-831 or Atazanavir with or&#xD;
      without Dexamethasone. Investigators are primarily interested in the time to recovery. In&#xD;
      addition to study medications there will be daily symptom surveys for 14 days, then weekly&#xD;
      thereafter for 3 weeks resulting in a total duration of follow up of 36 days. During&#xD;
      hospitalization, daily symptom surveys will be carried out in conjunction with the study&#xD;
      coordinators. Upon discharge participants will have the option to complete electronic symptom&#xD;
      surveys or complete symptom surveys via telephone with the study coordinator. If electronic&#xD;
      symptom surveys are selected on discharge participants will also receive a follow-up call&#xD;
      from a study coordination every 7 days during the initial 14 day period. In addition, failure&#xD;
      to submit a symptom survey will prompt a study follow up call.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 15, 2022</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1. Time (Hours) to recovery</measure>
    <time_frame>[ Time Frame: 36 days ]</time_frame>
    <description>Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time fever resolution</measure>
    <time_frame>[ Time Frame: 36 days ]</time_frame>
    <description>Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">525</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Severe Acute Respiratory Infection</condition>
  <condition>Severe Acute Respiratory Syndrome Coronavirus 2</condition>
  <arm_group>
    <arm_group_label>Active Comparator: NA-831 alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 1: NA-831 30 mg orally twice a day for one day, followed by 30 mg once day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: NA-831 plus Atazanavir Sulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 2: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule.&#xD;
AND Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: NA-83 plus Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active Comparator: NA-831 30 mg capsule plus Dexamethasone 4 mg Arm 3: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule.&#xD;
AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: Atazanavir and Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets.&#xD;
AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug: NA-831</intervention_name>
    <description>NA-831 is a neuroprotective drug, available at 30 mg capsule</description>
    <arm_group_label>Active Comparator: NA-831 alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>NA-831 and Atazanavir</intervention_name>
    <description>Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule&#xD;
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet</description>
    <arm_group_label>Active Comparator: NA-831 plus Atazanavir Sulfate</arm_group_label>
    <other_name>and Atazanavir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>NA-831and Dexamethasone</intervention_name>
    <description>Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule&#xD;
Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg</description>
    <arm_group_label>Active Comparator: NA-83 plus Dexamethasone</arm_group_label>
    <other_name>Dexamethasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Atazanavir and Dexamethasone</intervention_name>
    <description>Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg</description>
    <arm_group_label>Active Comparator: Atazanavir and Dexamethasone</arm_group_label>
    <other_name>Dexamethasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalization for management of SARS CoV-2 infection&#xD;
&#xD;
          -  Positive SARS CoV-2 test&#xD;
&#xD;
          -  Age &gt; = 18 years&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
          -  Electrocardiogram (ECG) ≤ 48 hours prior to enrollment&#xD;
&#xD;
          -  Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive&#xD;
             metabolic panel and magnesium ≤ 48 hours prior to enrollment from standard of care.&#xD;
&#xD;
          -  If participating in sexual activity that could lead to pregnancy, individuals of&#xD;
             reproductive potential who can become pregnant must agree to use contraception&#xD;
             throughout the study. At least one of the following must be used throughout the study:&#xD;
&#xD;
               -  Condom (male or female) with or without spermicide&#xD;
&#xD;
               -  Diaphragm or cervical cap with spermicide&#xD;
&#xD;
               -  Intrauterine device (IUD)&#xD;
&#xD;
               -  Hormone-based contraceptive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication or allergy to NA-831, Atazanavir, Dexamethasone&#xD;
&#xD;
          -  Current use any antiviral drug or anti-inflammatory drug&#xD;
&#xD;
          -  Concurrent use of another investigational agent&#xD;
&#xD;
          -  Invasive mechanical ventilation&#xD;
&#xD;
          -  Participants who have any severe and/or uncontrolled medical conditions such as:&#xD;
&#xD;
               -  unstable angina pectoris,&#xD;
&#xD;
               -  symptomatic congestive heart failure,&#xD;
&#xD;
               -  myocardial infarction,&#xD;
&#xD;
               -  cardiac arrhythmias or know prolonged QTc &gt; 470 males, &gt; 480 female on ECG&#xD;
&#xD;
               -  pulmonary insufficiency,&#xD;
&#xD;
               -  epilepsy (interaction with chloroquine),&#xD;
&#xD;
          -  Prior retinal eye disease&#xD;
&#xD;
          -  Concurrent malignancy requiring chemotherapy&#xD;
&#xD;
          -  Known Chronic Kidney disease, eGFR &lt; 10 or dialysis&#xD;
&#xD;
          -  G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment&#xD;
&#xD;
               -  Known Porphyria&#xD;
&#xD;
               -  Known myasthenia gravis&#xD;
&#xD;
               -  Currently pregnant or planning on getting pregnant while on study&#xD;
&#xD;
               -  Breast feeding&#xD;
&#xD;
               -  AST/ALT &gt; five times the upper limit of normal ULN&#xD;
&#xD;
               -  Bilirubin &gt; five times the ULN&#xD;
&#xD;
               -  Magnesium &lt; 1.4 mEq/L&#xD;
&#xD;
               -  Calcium &lt; 8.4 mg/dL &gt; 10.6 mg/dL&#xD;
&#xD;
               -  Potassium &lt; 3.3 &gt; 5.5 mEg/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lloyd Tran, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Biomed Industries, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brian Tran, MD</last_name>
    <phone>800-824-5135</phone>
    <email>BTran@biomedind.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Frank Kennedy, PhD</last_name>
    <phone>800-824-5135</phone>
    <email>FKennedy@biomedind.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Coronavirus Research Institute- Testing Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92314</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Testing Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Sunnyvale</city>
        <state>California</state>
        <zip>94086</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lloyd Tran, PhD</last_name>
      <phone>800-82405135</phone>
      <email>LTran@biomedind.com</email>
    </contact>
    <contact_backup>
      <last_name>Markku Kurkinen, PhD</last_name>
      <phone>800-824-5135</phone>
      <email>MKurkinen@biomedind.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33620</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute- Testing Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site-</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute- Testing Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute- Testing Site</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coronavirus Research Institute-Testing Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NA-831</keyword>
  <keyword>Atazanavir</keyword>
  <keyword>Dexamethasone</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus Infection</keyword>
  <keyword>Severe Acute Respiratory Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atazanavir Sulfate</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04452565
org study id: NATADEX
nct id: NCT04452565
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized
      participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2
      infection, in which participants will receive NA-831 or Atazanavir with or without
      Dexamethasone.
The clinical Phase 2/3 evaluates the safety and efficacy of NA-831 alone, and a combination
      therapy comprises NA-831 with an anti-viral drug Atazanavir, NA-831 with an anti-inflammatory
      drug, Dexamethasone and a potential synergy between Atazanavir and Dexamethasone. NA-831 is
      also known as Traneurocin is a neuroprotective drug that is in clinical study for the
      treatment of Alzheimer's Disease. Participants will receive NA-831 or Atazanavir with or
      without Dexamethasone. Investigators are primarily interested in the time to recovery. In
      addition to study medications there will be daily symptom surveys for 14 days, then weekly
      thereafter for 3 weeks resulting in a total duration of follow up of 36 days. During
      hospitalization, daily symptom surveys will be carried out in conjunction with the study
      coordinators. Upon discharge participants will have the option to complete electronic symptom
      surveys or complete symptom surveys via telephone with the study coordinator. If electronic
      symptom surveys are selected on discharge participants will also receive a follow-up call
      from a study coordination every 7 days during the initial 14 day period. In addition, failure
      to submit a symptom survey will prompt a study follow up call.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: 1. Time (Hours) to recovery
time frame: [ Time Frame: 36 days ]
description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death
measure: Time fever resolution
time frame: [ Time Frame: 36 days ]
description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications
arm group label: Active Comparator: NA-831 alone
arm group type: Active Comparator
description: Arm 1: NA-831 30 mg orally twice a day for one day, followed by 30 mg once day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule
arm group label: Active Comparator: NA-831 plus Atazanavir Sulfate
arm group type: Active Comparator
description: Arm 2: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule.
AND Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets.
arm group label: Active Comparator: NA-83 plus Dexamethasone
arm group type: Active Comparator
description: Active Comparator: NA-831 30 mg capsule plus Dexamethasone 4 mg Arm 3: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule.
AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets.
arm group label: Active Comparator: Atazanavir and Dexamethasone
arm group type: Active Comparator
description: Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets.
AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets.
intervention type: Drug
intervention name: Drug: NA-831
description: NA-831 is a neuroprotective drug, available at 30 mg capsule
arm group label: Active Comparator: NA-831 alone
intervention type: Combination Product
intervention name: NA-831 and Atazanavir
description: Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet
arm group label: Active Comparator: NA-831 plus Atazanavir Sulfate
other name: and Atazanavir
intervention type: Combination Product
intervention name: NA-831and Dexamethasone
description: Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule
Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
arm group label: Active Comparator: NA-83 plus Dexamethasone
other name: Dexamethasone
intervention type: Combination Product
intervention name: Atazanavir and Dexamethasone
description: Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
arm group label: Active Comparator: Atazanavir and Dexamethasone
other name: Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lloyd Tran, PhD
role: Study Director
affiliation: Biomed Industries, Inc.
last name: Brian Tran, MD
phone: 800-824-5135
email: BTran@biomedind.com
last name: Frank Kennedy, PhD
phone: 800-824-5135
email: FKennedy@biomedind.com
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Respiratory Tract Infections
mesh term: Severe Acute Respiratory Syndrome
mesh term: Atazanavir Sulfate
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101
sharing ipd: No