NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection
NATADEX
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
1 other identifier
interventional
525
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2022
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedFebruary 16, 2022
January 1, 2022
1.5 years
June 26, 2020
January 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Time (Hours) to recovery
Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death
[ Time Frame: 36 days ]
Secondary Outcomes (1)
Time fever resolution
[ Time Frame: 36 days ]
Study Arms (4)
Active Comparator: NA-831 alone
ACTIVE COMPARATORArm 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: NA-831 plus Atazanavir Sulfate
ACTIVE COMPARATORArm 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: NA-83 plus Dexamethasone
ACTIVE COMPARATORActive 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: Atazanavir and Dexamethasone
ACTIVE COMPARATORAtazanavir 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
NA-831 is a neuroprotective drug, available at 30 mg capsule
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Coronavirus Research Institute- Testing Site
Los Angeles, California, 90095, United States
Coronavirus Research Institute
Orange, California, 92868, United States
Coronavirus Research Institute-Testing Site
Palo Alto, California, 94304, United States
Coronavirus Research Institute-Testing Site
Sacramento, California, 95817, United States
Coronavirus Research Institute-Testing Site
San Diego, California, 92314, United States
Coronavirus Research Testing Site
San Francisco, California, 94110, United States
Coronavirus Research Institute-Testing Site
Sunnyvale, California, 94086, United States
Coronavirus Research Institute-Testing Site
Washington D.C., District of Columbia, 20007, United States
Coronavirus Research Institute-Testing Site
Washington D.C., District of Columbia, 20010, United States
Coronavirus Research Institute-Testing Site
Fort Lauderdale, Florida, 33308, United States
Coronavirus Research Institute-Testing Site
Tampa, Florida, 33620, United States
Coronavirus Research Institute- Testing Site
Chicago, Illinois, 60612, United States
Coronavirus Research Institute-Testing Site
Naperville, Illinois, 60540, United States
Coronavirus Research Institute-Testing Site
Baltimore, Maryland, 21287, United States
Coronavirus Research Institute-Testing Site
Bethesda, Maryland, 20892, United States
Coronavirus Research Institute-Testing Site
Boston, Massachusetts, 02114, United States
Coronavirus Research Institute-Testing Site
Worcester, Massachusetts, 01655, United States
Coronavirus Research Institute-Testing Site
Ann Arbor, Michigan, 48109, United States
Coronavirus Research Institute-Testing Site
Detroit, Michigan, 48202, United States
Coronavirus Research Institute-Testing Site
Newark, New Jersey, 07102, United States
Coronavirus Research Institute-Testing Site
New York, New York, 10016, United States
Coronavirus Research Institute- Testing Site
Rochester, New York, 14642, United States
Coronavirus Research Institute-Testing Site-
The Bronx, New York, 10467, United States
Coronavirus Research Institute-Testing Site
Durham, North Carolina, 27704, United States
Coronavirus Research Institute-Testing Site
Philadelphia, Pennsylvania, 19104, United States
Coronavirus Research Institute- Testing Site
Fort Sam Houston, Texas, 78234, United States
Coronavirus Research Institute-Testing Site
Galveston, Texas, 77555, United States
Coronavirus Research Institute-Testing Site
Houston, Texas, 77030, United States
Coronavirus Research Institute-Testing Site
Kirkland, Washington, 98034, United States
Coronavirus Research Institute-Testing Site
Seattle, Washington, 98104, United States
Coronavirus Research Institute-Testing Site
Tacoma, Washington, 98431, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lloyd Tran, PhD
Biomed Industries, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2020
First Posted
June 30, 2020
Study Start
June 15, 2022
Primary Completion
December 15, 2023
Study Completion
December 15, 2023
Last Updated
February 16, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share