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

  • STATUS
    Recruiting
  • participants needed
    525
  • sponsor
    NeuroActiva, Inc.
Updated on 13 June 2021
Investigator
Brian Tran, MD
Primary Contact
Coronavirus Research Institute-Testing Site (5.3 mi away) Contact
+29 other location
mechanical ventilation
critical illness
covid-19
SARS
dexamethasone

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.

Description

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. Data from

Details
Condition Coronavirus Infection, Coronavirus, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2, severe acute respiratory infection (sari)
Treatment Drug: NA-831, NA-831 and Atazanavir, NA-831and Dexamethasone, Atazanavir and Dexamethasone
Clinical Study IdentifierNCT04452565
SponsorNeuroActiva, Inc.
Last Modified on13 June 2021

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