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. Data from
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, 90095
Coronavirus Research Institute
Orange, California, 92868
Coronavirus Research Institute-Testing Site
Palo Alto, California, 94304
Coronavirus Research Institute-Testing Site
Sacramento, California, 95817
Coronavirus Research Institute-Testing Site
San Diego, California, 92314
Coronavirus Research Testing Site
San Francisco, California, 94110
Coronavirus Research Institute-Testing Site
Sunnyvale, California, 94086
Investigator: Lloyd Tran, PhD
Contact: 415-941-3133
Investigator: Markku Kurkinen, PhD
Contact: 1-415-914-3133
Coronavirus Research Institute-Testing Site
Washington, District of Columbia, 20007
Coronavirus Research Institute-Testing Site
Washington, District of Columbia, 20010
Coronavirus Research Institute-Testing Site
Fort Lauderdale, Florida, 33308
Coronavirus Research Institute-Testing Site
Tampa, Florida, 33620
Coronavirus Research Institute- Testing Site
Chicago, Illinois, 60612
Coronavirus Research Institute-Testing Site
Naperville, Illinois, 60540
Coronavirus Research Institute-Testing Site
Baltimore, Maryland, 21287
Coronavirus Research Institute-Testing Site
Bethesda, Maryland, 20892
Coronavirus Research Institute-Testing Site
Boston, Massachusetts, 02114
Coronavirus Research Institute-Testing Site
Worcester, Massachusetts, 01655
Coronavirus Research Institute-Testing Site
Ann Arbor, Michigan, 48109
Coronavirus Research Institute-Testing Site
Detroit, Michigan, 48202
Coronavirus Research Institute-Testing Site
Newark, New Jersey, 07102
Coronavirus Research Institute-Testing Site-
Bronx, New York, 10467
Coronavirus Research Institute-Testing Site
New York, New York, 10016
Coronavirus Research Institute- Testing Site
Rochester, New York, 14642
Coronavirus Research Institute-Testing Site
Durham, North Carolina, 27704
Coronavirus Research Institute-Testing Site
Philadelphia, Pennsylvania, 19104
Coronavirus Research Institute- Testing Site
Fort Sam Houston, Texas, 78234
Coronavirus Research Institute-Testing Site
Galveston, Texas, 77555
Coronavirus Research Institute-Testing Site
Houston, Texas, 77030
Coronavirus Research Institute-Testing Site
Kirkland, Washington, 98034
Coronavirus Research Institute-Testing Site
Seattle, Washington, 98104
Coronavirus Research Institute-Testing Site
Tacoma, Washington, 98431
Brian Tran, MD
1-415-941-3133
BTran@neuroactiva.com
Frank Kennedy, PhD
1-415-941-3133
FKennedy@neuroactiva.com
Lloyd Tran, PhD
Study Director
NeuroActiva, Inc.