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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: NA-831 alone | Active Comparator | 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 |
|
| Active Comparator: NA-831 plus Atazanavir Sulfate | Active Comparator | 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. |
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| Active Comparator: NA-83 plus Dexamethasone | Active Comparator | 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. |
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| Active Comparator: Atazanavir and Dexamethasone | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: NA-831 | Drug | NA-831 is a neuroprotective drug, available at 30 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Time (Hours) to recovery | 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 | [ Time Frame: 36 days ] |
| Measure | Description | Time Frame |
|---|---|---|
| Time fever resolution | Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications | [ Time Frame: 36 days ] |
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Inclusion Criteria:
Hospitalization for management of SARS CoV-2 infection
Positive SARS CoV-2 test
Age > = 18 years
Provision of informed consent
Electrocardiogram (ECG) ≤ 48 hours prior to enrollment
Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium ≤ 48 hours prior to enrollment from standard of care.
If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:
Exclusion Criteria:
Contraindication or allergy to NA-831, Atazanavir, Dexamethasone
Current use any antiviral drug or anti-inflammatory drug
Concurrent use of another investigational agent
Invasive mechanical ventilation
Participants who have any severe and/or uncontrolled medical conditions such as:
Prior retinal eye disease
Concurrent malignancy requiring chemotherapy
Known Chronic Kidney disease, eGFR < 10 or dialysis
G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Tran, MD | Contact | 800-824-5135 | BTran@biomedind.com | |
| Frank Kennedy, PhD | Contact | 800-824-5135 | FKennedy@biomedind.com |
| Name | Affiliation | Role |
|---|---|---|
| Lloyd Tran, PhD | Biomed Industries, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coronavirus Research Institute- Testing Site | Recruiting | Los Angeles | California | 90095 | United States | |
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| NA-831 and Atazanavir | Combination Product | Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet |
|
|
| NA-831and Dexamethasone | Combination Product | Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg |
|
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| Atazanavir and Dexamethasone | Combination Product | Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg |
|
|
| Coronavirus Research Institute |
| Recruiting |
| Orange |
| California |
| 92868 |
| United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Palo Alto | California | 94304 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Sacramento | California | 95817 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | San Diego | California | 92314 | United States |
| Coronavirus Research Testing Site | Recruiting | San Francisco | California | 94110 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Sunnyvale | California | 94086 | United States |
|
| Coronavirus Research Institute-Testing Site | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| Coronavirus Research Institute-Testing Site | Not yet recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Tampa | Florida | 33620 | United States |
| Coronavirus Research Institute- Testing Site | Recruiting | Chicago | Illinois | 60612 | United States |
| Coronavirus Research Institute-Testing Site | Not yet recruiting | Naperville | Illinois | 60540 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Baltimore | Maryland | 21287 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Bethesda | Maryland | 20892 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Boston | Massachusetts | 02114 | United States |
| Coronavirus Research Institute-Testing Site | Not yet recruiting | Worcester | Massachusetts | 01655 | United States |
| Coronavirus Research Institute-Testing Site | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Detroit | Michigan | 48202 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Newark | New Jersey | 07102 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | New York | New York | 10016 | United States |
| Coronavirus Research Institute- Testing Site | Not yet recruiting | Rochester | New York | 14642 | United States |
| Coronavirus Research Institute-Testing Site- | Recruiting | The Bronx | New York | 10467 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Durham | North Carolina | 27704 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Coronavirus Research Institute- Testing Site | Recruiting | Fort Sam Houston | Texas | 78234 | United States |
| Coronavirus Research Institute-Testing Site | Not yet recruiting | Galveston | Texas | 77555 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Houston | Texas | 77030 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Kirkland | Washington | 98034 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Seattle | Washington | 98104 | United States |
| Coronavirus Research Institute-Testing Site | Recruiting | Tacoma | Washington | 98431 | United States |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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