NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection

Purpose

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.

Conditions

  • Coronavirus Infection
  • Severe Acute Respiratory Infection
  • Severe Acute Respiratory Syndrome Coronavirus 2

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Active Comparator: NA-831 alone 		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
  • Drug: Drug: NA-831
    NA-831 is a neuroprotective drug, available at 30 mg capsule
Active Comparator
Active Comparator: NA-831 plus Atazanavir Sulfate 		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.
  • 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 names:
    • and Atazanavir
Active Comparator
Active Comparator: NA-83 plus Dexamethasone 		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.
  • 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 names:
    • Dexamethasone
Active Comparator
Active Comparator: Atazanavir and Dexamethasone 		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.
  • 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 names:
    • Dexamethasone

Recruiting Locations

Coronavirus Research Institute- Testing Site
Los Angeles 5368361, California 5332921 90095

Coronavirus Research Institute
Orange 5379513, California 5332921 92868

Coronavirus Research Institute-Testing Site
Palo Alto 5380748, California 5332921 94304

Coronavirus Research Institute-Testing Site
Sacramento 5389489, California 5332921 95817

Coronavirus Research Institute-Testing Site
San Diego 5391811, California 5332921 92314

Coronavirus Research Testing Site
San Francisco 5391959, California 5332921 94110

Coronavirus Research Institute-Testing Site
Sunnyvale 5400075, California 5332921 94086
Contact:
Lloyd Tran, PhD
800-82405135
LTran@biomedind.com

Coronavirus Research Institute-Testing Site
Washington D.C. 4140963, District of Columbia 4138106 20007

Coronavirus Research Institute-Testing Site
Fort Lauderdale 4155966, Florida 4155751 33308

Coronavirus Research Institute-Testing Site
Tampa 4174757, Florida 4155751 33620

Coronavirus Research Institute- Testing Site
Chicago 4887398, Illinois 4896861 60612

Coronavirus Research Institute-Testing Site
Baltimore 4347778, Maryland 4361885 21287

Coronavirus Research Institute-Testing Site
Bethesda 4348599, Maryland 4361885 20892

Coronavirus Research Institute-Testing Site
Boston 4930956, Massachusetts 6254926 02114

Coronavirus Research Institute-Testing Site
Detroit 4990729, Michigan 5001836 48202

Coronavirus Research Institute-Testing Site
Newark 5101798, New Jersey 5101760 07102

Coronavirus Research Institute-Testing Site
New York 5128581, New York 5128638 10016

Coronavirus Research Institute-Testing Site-
The Bronx 5110266, New York 5128638 10467

Coronavirus Research Institute-Testing Site
Durham 4464368, North Carolina 4482348 27704

Coronavirus Research Institute-Testing Site
Philadelphia 4560349, Pennsylvania 6254927 19104

Coronavirus Research Institute- Testing Site
Fort Sam Houston 7267736, Texas 4736286 78234

Coronavirus Research Institute-Testing Site
Houston 4699066, Texas 4736286 77030

Coronavirus Research Institute-Testing Site
Kirkland 5799841, Washington 5815135 98034

Coronavirus Research Institute-Testing Site
Seattle 5809844, Washington 5815135 98104

Coronavirus Research Institute-Testing Site
Tacoma 5812944, Washington 5815135 98431

More Details

NCT ID
NCT04452565
Status
Unknown status
Sponsor
Biomed Industries, Inc.

Study Contact

Brian Tran, MD
800-824-5135
BTran@biomedind.com

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.