NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection (NATADEX)
Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2
About this trial
This is an interventional prevention trial for Coronavirus Infection focused on measuring NA-831, Atazanavir, Dexamethasone, COVID-19, Coronavirus Infection, Severe Acute Respiratory Syndrome
Eligibility Criteria
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:
- Condom (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive
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:
- 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
Sites / Locations
- Coronavirus Research Institute- Testing SiteRecruiting
- Coronavirus Research InstituteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing Site
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute- Testing SiteRecruiting
- Coronavirus Research Institute-Testing Site
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing Site
- Coronavirus Research Institute-Testing Site
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing Site-Recruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute- Testing Site
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute- Testing SiteRecruiting
- Coronavirus Research Institute-Testing Site
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
- Coronavirus Research Institute-Testing SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator: NA-831 alone
Active Comparator: NA-831 plus Atazanavir Sulfate
Active Comparator: NA-83 plus Dexamethasone
Active Comparator: Atazanavir and Dexamethasone
Arm 1: NA-831 30 mg orally twice a day for one day, followed by 30 mg once day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule
Arm 2: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule. AND Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets.
Active Comparator: NA-831 30 mg capsule plus Dexamethasone 4 mg Arm 3: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule. AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets.
Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets. AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets.