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

NCT ID: NCT04452565

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Drug: NA-831

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

NA-831 and Atazanavir

Intervention Type COMBINATION_PRODUCT

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-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.

Group Type ACTIVE_COMPARATOR

NA-831and Dexamethasone

Intervention Type COMBINATION_PRODUCT

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

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

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.

Group Type ACTIVE_COMPARATOR

Atazanavir and Dexamethasone

Intervention Type COMBINATION_PRODUCT

Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg

Interventions

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Drug: NA-831

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

Intervention Type DRUG

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

Intervention Type 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

Intervention Type 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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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and Atazanavir Dexamethasone Dexamethasone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomed Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lloyd Tran, PhD

Role: STUDY_DIRECTOR

Biomed Industries, Inc.

Locations

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Coronavirus Research Institute- Testing Site

Los Angeles, California, United States

Site Status RECRUITING

Coronavirus Research Institute

Orange, California, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Palo Alto, California, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Sacramento, California, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

San Diego, California, United States

Site Status RECRUITING

Coronavirus Research Testing Site

San Francisco, California, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Sunnyvale, California, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Washington D.C., District of Columbia, United States

Site Status NOT_YET_RECRUITING

Coronavirus Research Institute-Testing Site

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Tampa, Florida, United States

Site Status RECRUITING

Coronavirus Research Institute- Testing Site

Chicago, Illinois, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Naperville, Illinois, United States

Site Status NOT_YET_RECRUITING

Coronavirus Research Institute-Testing Site

Baltimore, Maryland, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Bethesda, Maryland, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Boston, Massachusetts, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Worcester, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Coronavirus Research Institute-Testing Site

Ann Arbor, Michigan, United States

Site Status NOT_YET_RECRUITING

Coronavirus Research Institute-Testing Site

Detroit, Michigan, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Newark, New Jersey, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

New York, New York, United States

Site Status RECRUITING

Coronavirus Research Institute- Testing Site

Rochester, New York, United States

Site Status NOT_YET_RECRUITING

Coronavirus Research Institute-Testing Site-

The Bronx, New York, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Durham, North Carolina, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Coronavirus Research Institute- Testing Site

Fort Sam Houston, Texas, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Galveston, Texas, United States

Site Status NOT_YET_RECRUITING

Coronavirus Research Institute-Testing Site

Houston, Texas, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Kirkland, Washington, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Seattle, Washington, United States

Site Status RECRUITING

Coronavirus Research Institute-Testing Site

Tacoma, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brian Tran, MD

Role: CONTACT

[email protected]
800-824-5135

Frank Kennedy, PhD

Role: CONTACT

[email protected]
800-824-5135

Facility Contacts

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Lloyd Tran, PhD

Role: primary

[email protected]
800-82405135

Markku Kurkinen, PhD

Role: backup

[email protected]
800-824-5135

Other Identifiers

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NATADEX

Identifier Type: -

Identifier Source: org_study_id

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