Recruiting

Phase 2

Phase 3

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

Sponsor:

Biomed Industries, Inc.

Code:

NCT04452565

Conditions

Coronavirus Infection

Severe Acute Respiratory Infection

Severe Acute Respiratory Syndrome Coronavirus 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Drug: NA-831

NA-831 and Atazanavir

NA-831and Dexamethasone

Atazanavir and Dexamethasone

Study Details

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.

Conditions

Coronavirus Infection

Severe Acute Respiratory Infection

Severe Acute Respiratory Syndrome Coronavirus 2

Study ID

NCT04452565

Start date

Jun 15, 2022

Status verified date

Jan, 2022

Completion date

Dec 15, 2023

Anticipated

Primary completion date

Dec 15, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

525 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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.

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.

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.

Interventions

Drug: NA-831

NA-831 is a neuroprotective drug, available at 30 mg capsule

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

NA-831and Dexamethasone

Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule

Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg

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

Primary outcome measure

1. Time (Hours) to recovery [ Time Frame: [ Time Frame: 36 days ] ]

Central Contacts and Locations

Central contacts

Brian Tran, MD

800-824-5135 BTran@biomedind.com

Frank Kennedy, PhD

800-824-5135 FKennedy@biomedind.com

Locations

Coronavirus Research Institute- Testing Site

Recruiting

Los Angeles, California, United States, 90095

Coronavirus Research Institute

Recruiting

Orange, California, United States, 92868

Coronavirus Research Institute-Testing Site

Recruiting

Palo Alto, California, United States, 94304

Coronavirus Research Institute-Testing Site

Recruiting

Sacramento, California, United States, 95817

Coronavirus Research Institute-Testing Site

Recruiting

San Diego, California, United States, 92314

Coronavirus Research Testing Site

Recruiting

San Francisco, California, United States, 94110

Coronavirus Research Institute-Testing Site

Recruiting

Sunnyvale, California, United States, 94086

Contacts

Lloyd Tran, PhD

800-82405135 LTran@biomedind.com

Markku Kurkinen, PhD

800-824-5135 MKurkinen@biomedind.com

Coronavirus Research Institute-Testing Site

Recruiting

Washington, District of Columbia, United States, 20007

Coronavirus Research Institute-Testing Site

Recruiting

Fort Lauderdale, Florida, United States, 33308

Coronavirus Research Institute-Testing Site

Recruiting

Tampa, Florida, United States, 33620

Coronavirus Research Institute- Testing Site

Recruiting

Chicago, Illinois, United States, 60612

Coronavirus Research Institute-Testing Site

Recruiting

Baltimore, Maryland, United States, 21287

Coronavirus Research Institute-Testing Site

Recruiting

Bethesda, Maryland, United States, 20892

Coronavirus Research Institute-Testing Site

Recruiting

Boston, Massachusetts, United States, 02114

Coronavirus Research Institute-Testing Site

Recruiting

Detroit, Michigan, United States, 48202

Coronavirus Research Institute-Testing Site

Recruiting

Newark, New Jersey, United States, 07102

Coronavirus Research Institute-Testing Site-

Recruiting

Bronx, New York, United States, 10467

Coronavirus Research Institute-Testing Site

Recruiting

New York, New York, United States, 10016

Coronavirus Research Institute-Testing Site

Recruiting

Durham, North Carolina, United States, 27704

Coronavirus Research Institute-Testing Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Coronavirus Research Institute- Testing Site

Recruiting

Fort Sam Houston, Texas, United States, 78234

Coronavirus Research Institute-Testing Site

Recruiting

Houston, Texas, United States, 77030

Coronavirus Research Institute-Testing Site

Recruiting

Kirkland, Washington, United States, 98034

Coronavirus Research Institute-Testing Site

Recruiting

Seattle, Washington, United States, 98104

Coronavirus Research Institute-Testing Site

Recruiting

Tacoma, Washington, United States, 98431

More Information

Sponsor

Biomed Industries, Inc.

Last update posted

Feb 16, 2022

Last verified

Jan, 2022

Keywords

NA-831
Atazanavir
Dexamethasone
COVID-19
Coronavirus Infection
Severe Acute Respiratory Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Biomed Industries, Inc. on 2022-02-16.