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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
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Coronavirus Research Institute- Testing Site
Los Angeles, California, United States
Coronavirus Research Institute
Orange, California, United States
Coronavirus Research Institute-Testing Site
Palo Alto, California, United States
Coronavirus Research Institute-Testing Site
Sacramento, California, United States
Coronavirus Research Institute-Testing Site
San Diego, California, United States
Coronavirus Research Testing Site
San Francisco, California, United States
Coronavirus Research Institute-Testing Site
Sunnyvale, California, United States
Coronavirus Research Institute-Testing Site
Washington D.C., District of Columbia, United States
Coronavirus Research Institute-Testing Site
Washington D.C., District of Columbia, United States
Coronavirus Research Institute-Testing Site
Fort Lauderdale, Florida, United States
Start Date
June 15, 2022
Primary Completion Date
December 15, 2023
Completion Date
December 15, 2023
Last Updated
February 16, 2022
525
ESTIMATED participants
Drug: NA-831
DRUG
NA-831 and Atazanavir
COMBINATION_PRODUCT
NA-831and Dexamethasone
COMBINATION_PRODUCT
Atazanavir and Dexamethasone
COMBINATION_PRODUCT
Lead Sponsor
Biomed Industries, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04510025