Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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:
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:
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
Primary purpose
Allocation
Interventional model
Masking
525 participants in 4 patient groups
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Central trial contact
Frank Kennedy, PhD; Brian Tran, MD
Data sourced from clinicaltrials.gov
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