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

• Status: Recruiting
• Trial end date: 2021-02-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuroActiva, Inc.
• Treatments: Atazanavir Sulfate; BB 1101; Dexamethasone; Dexamethasone acetate

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