Status:
UNKNOWN
NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection
Lead Sponsor:
Biomed Industries, Inc.
Conditions:
Coronavirus Infection
Severe Acute Respiratory Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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 whic...
Detailed 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, Dexameth...
Eligibility Criteria
Inclusion
- 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:
- Condom (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive
Exclusion
- 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:
- unstable angina pectoris,
- symptomatic congestive heart failure,
- myocardial infarction,
- cardiac arrhythmias or know prolonged QTc \> 470 males, \> 480 female on ECG
- pulmonary insufficiency,
- epilepsy (interaction with chloroquine),
- 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
- Known Porphyria
- Known myasthenia gravis
- Currently pregnant or planning on getting pregnant while on study
- Breast feeding
- AST/ALT \> five times the upper limit of normal ULN
- Bilirubin \> five times the ULN
- Magnesium \< 1.4 mEq/L
- Calcium \< 8.4 mg/dL \> 10.6 mg/dL
- Potassium \< 3.3 \> 5.5 mEg/L
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT04452565
Start Date
June 15 2022
End Date
December 15 2023
Last Update
February 16 2022
Active Locations (31)
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1
Coronavirus Research Institute- Testing Site
Los Angeles, California, United States, 90095
2
Coronavirus Research Institute
Orange, California, United States, 92868
3
Coronavirus Research Institute-Testing Site
Palo Alto, California, United States, 94304
4
Coronavirus Research Institute-Testing Site
Sacramento, California, United States, 95817