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
Brief Summary

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.

Detailed Description

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

Recruiting
Coronavirus Infection
Severe Acute Respiratory Infection
Severe Acute Respiratory Syndrome Coronavirus 2

Drug: Drug: NA-831
NA-831 is a neuroprotective drug, available at 30 mg capsule
Active Comparator: NA-831 alone

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
Active Comparator: NA-831 plus Atazanavir Sulfate
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
Active Comparator: NA-83 plus Dexamethasone
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
Active Comparator: Atazanavir and Dexamethasone
Other Name: Dexamethasone

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 80 Years
Countries
United States
Locations

Coronavirus Research Institute- Testing Site
Los Angeles, California, 90095

Recruiting

Coronavirus Research Institute
Orange, California, 92868

Recruiting

Coronavirus Research Institute-Testing Site
Palo Alto, California, 94304

Recruiting

Coronavirus Research Institute-Testing Site
Sacramento, California, 95817

Recruiting

Coronavirus Research Institute-Testing Site
San Diego, California, 92314

Recruiting

Coronavirus Research Testing Site
San Francisco, California, 94110

Recruiting

Coronavirus Research Institute-Testing Site
Sunnyvale, California, 94086

Recruiting

Investigator: Lloyd Tran, PhD
Contact: 415-941-3133
LTran@neuroactiva.com


Investigator: Markku Kurkinen, PhD
Contact: 1-415-914-3133
MKurkinen@neuroactiva.com

Coronavirus Research Institute-Testing Site
Washington, District of Columbia, 20007

Recruiting

Coronavirus Research Institute-Testing Site
Washington, District of Columbia, 20010

Not yet recruiting

Coronavirus Research Institute-Testing Site
Fort Lauderdale, Florida, 33308

Recruiting

Coronavirus Research Institute-Testing Site
Tampa, Florida, 33620

Recruiting

Coronavirus Research Institute- Testing Site
Chicago, Illinois, 60612

Recruiting

Coronavirus Research Institute-Testing Site
Naperville, Illinois, 60540

Not yet recruiting

Coronavirus Research Institute-Testing Site
Baltimore, Maryland, 21287

Recruiting

Coronavirus Research Institute-Testing Site
Bethesda, Maryland, 20892

Recruiting

Coronavirus Research Institute-Testing Site
Boston, Massachusetts, 02114

Recruiting

Coronavirus Research Institute-Testing Site
Worcester, Massachusetts, 01655

Not yet recruiting

Coronavirus Research Institute-Testing Site
Ann Arbor, Michigan, 48109

Not yet recruiting

Coronavirus Research Institute-Testing Site
Detroit, Michigan, 48202

Recruiting

Coronavirus Research Institute-Testing Site
Newark, New Jersey, 07102

Recruiting

Coronavirus Research Institute-Testing Site-
Bronx, New York, 10467

Recruiting

Coronavirus Research Institute-Testing Site
New York, New York, 10016

Recruiting

Coronavirus Research Institute- Testing Site
Rochester, New York, 14642

Not yet recruiting

Coronavirus Research Institute-Testing Site
Durham, North Carolina, 27704

Recruiting

Coronavirus Research Institute-Testing Site
Philadelphia, Pennsylvania, 19104

Recruiting

Coronavirus Research Institute- Testing Site
Fort Sam Houston, Texas, 78234

Recruiting

Coronavirus Research Institute-Testing Site
Galveston, Texas, 77555

Not yet recruiting

Coronavirus Research Institute-Testing Site
Houston, Texas, 77030

Recruiting

Coronavirus Research Institute-Testing Site
Kirkland, Washington, 98034

Recruiting

Coronavirus Research Institute-Testing Site
Seattle, Washington, 98104

Recruiting

Coronavirus Research Institute-Testing Site
Tacoma, Washington, 98431

Recruiting

Contacts

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.

NeuroActiva, Inc.
NCT Number
Keywords
NA-831
Atazanavir
dexamethasone
Covid-19
Coronavirus infection
Severe acute respiratory syndrome
MeSH Terms
Infection
Communicable Diseases
Respiratory Tract Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Atazanavir Sulfate
Dexamethasone
Dexamethasone acetate
BB 1101