MedTrace Logo

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

NCT04452565 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2022-02-16

No results posted yet for this study

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

Interventions

DRUG

Drug: NA-831

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

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

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

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

Sponsors & Collaborators

  • Biomed Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Lloyd Tran, PhD · Biomed Industries, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2023-12-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04452565 on ClinicalTrials.gov