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.
Drug: Drug: NA-831
NA-831 is a neuroprotective drug, available at 30 mg capsule
Combination Product: NA-831 and Atazanavir
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet
Other Name: and Atazanavir
Combination Product: NA-831and Dexamethasone
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule
Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Other Name: Dexamethasone
Combination Product: Atazanavir and Dexamethasone
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Other Name: Dexamethasone
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:
- Condom (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive
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:
- unstable angina pectoris,
- symptomatic congestive heart failure,
- myocardial infarction,
- cardiac arrhythmias or know prolonged QTc > 470 males, > 480 female on ECG
- pulmonary insufficiency,
- epilepsy (interaction with chloroquine),
- 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
- Known Porphyria
- Known myasthenia gravis
- Currently pregnant or planning on getting pregnant while on study
- Breast feeding
- AST/ALT > five times the upper limit of normal ULN
- Bilirubin > five times the ULN
- Magnesium < 1.4 mEq/L
- Calcium < 8.4 mg/dL > 10.6 mg/dL
- Potassium < 3.3 > 5.5 mEg/L
Coronavirus Research Institute- Testing Site
Los Angeles, California, United States
Coronavirus Research Institute
Orange, California, United States
Coronavirus Research Institute-Testing Site
Palo Alto, California, United States
Coronavirus Research Institute-Testing Site
Sacramento, California, United States
Coronavirus Research Institute-Testing Site
San Diego, California, United States
Coronavirus Research Testing Site
San Francisco, California, United States
Coronavirus Research Institute-Testing Site
Sunnyvale, California, United States
Coronavirus Research Institute-Testing Site
Washington, District of Columbia, United States
Coronavirus Research Institute-Testing Site
Washington, District of Columbia, United States
Coronavirus Research Institute-Testing Site
Fort Lauderdale, Florida, United States
Coronavirus Research Institute-Testing Site
Tampa, Florida, United States
Coronavirus Research Institute- Testing Site
Chicago, Illinois, United States
Coronavirus Research Institute-Testing Site
Naperville, Illinois, United States
Coronavirus Research Institute-Testing Site
Baltimore, Maryland, United States
Coronavirus Research Institute-Testing Site
Bethesda, Maryland, United States
Coronavirus Research Institute-Testing Site
Boston, Massachusetts, United States
Coronavirus Research Institute-Testing Site
Worcester, Massachusetts, United States
Coronavirus Research Institute-Testing Site
Ann Arbor, Michigan, United States
Coronavirus Research Institute-Testing Site
Detroit, Michigan, United States
Coronavirus Research Institute-Testing Site
Newark, New Jersey, United States
Coronavirus Research Institute-Testing Site-
Bronx, New York, United States
Coronavirus Research Institute-Testing Site
New York, New York, United States
Coronavirus Research Institute- Testing Site
Rochester, New York, United States
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Durham, North Carolina, United States
Coronavirus Research Institute-Testing Site
Philadelphia, Pennsylvania, United States
Coronavirus Research Institute- Testing Site
Fort Sam Houston, Texas, United States
Coronavirus Research Institute-Testing Site
Galveston, Texas, United States
Coronavirus Research Institute-Testing Site
Houston, Texas, United States
Coronavirus Research Institute-Testing Site
Kirkland, Washington, United States
Coronavirus Research Institute-Testing Site
Seattle, Washington, United States
Coronavirus Research Institute-Testing Site
Tacoma, Washington, United States
Brian Tran, MD
800-824-5135
BTran@biomedind.com
Frank Kennedy, PhD
800-824-5135
FKennedy@biomedind.com
Lloyd Tran, PhD, Study Director
Biomed Industries, Inc.