Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

NA-831AtazanavirDexamethasoneCOVID-19Coronavirus InfectionSevere Acute Respiratory Syndrome

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 COMPARATOR

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

Active Comparator: NA-831 plus Atazanavir Sulfate

ACTIVE COMPARATOR

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

Active Comparator: NA-83 plus Dexamethasone

ACTIVE COMPARATOR

Interventions

Drug: NA-831Drug

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

Active Comparator: NA-831 alone

NA-831 and AtazanavirCombination product

Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet

Also known as: and Atazanavir

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Atazanavir and Dexamethasone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Hospitalization for management of SARS CoV-2 infection
Positive SARS CoV-2 test

Sponsors & Collaborators

Biomed Industries, Inc.
Industrylead

Study Sites (31)

Coronavirus Research Institute- Testing Site

Los Angeles, California, 90095, United States

RECRUITING

Coronavirus Research Institute

Orange, California, 92868, United States

RECRUITING

Coronavirus Research Institute-Testing Site

Palo Alto, California, 94304, United States

RECRUITING

Coronavirus Research Institute-Testing Site

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19Severe Acute Respiratory Syndrome

Interventions

Atazanavir SulfateDexamethasone

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung Diseases

Study Officials

Lloyd Tran, PhD
Biomed Industries, Inc.
STUDY DIRECTOR

Central Study Contacts

Brian Tran, MD

CONTACT

800-824-5135 BTran@biomedind.com

Frank Kennedy, PhD

CONTACT

800-824-5135

Study Design

Study Type: interventional
Phase: phase 2 3
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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 15, 2023

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Active Comparator: NA-831 alone

Active Comparator: NA-831 plus Atazanavir Sulfate

Active Comparator: NA-83 plus Dexamethasone

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Active Comparator: Atazanavir and Dexamethasone

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Active Comparator: NA-831 alone

Active Comparator: NA-831 plus Atazanavir Sulfate

Active Comparator: NA-83 plus Dexamethasone

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Active Comparator: Atazanavir and Dexamethasone

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations