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

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2

In brief

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.

Key facts

Study ID

NCT04452565

Run by

Biomed Industries, Inc.

People needed

525

Starts

2022-06-15

Expected to finish

2023-12-15

Last updated by the study team

2022-02-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Coronavirus Research Institute-Testing Site — Tacoma, Washington, United States (enrolling)
• Coronavirus Research Institute — Orange, California, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Palo Alto, California, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Sacramento, California, United States (enrolling)
• Coronavirus Research Institute-Testing Site — San Diego, California, United States (enrolling)
• Coronavirus Research Testing Site — San Francisco, California, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Sunnyvale, California, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Washington D.C., District of Columbia, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Philadelphia, Pennsylvania, United States (enrolling)
• Coronavirus Research Institute- Testing Site — Fort Sam Houston, Texas, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Houston, Texas, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Kirkland, Washington, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Seattle, Washington, United States (enrolling)
• Coronavirus Research Institute- Testing Site — Los Angeles, California, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Fort Lauderdale, Florida, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Tampa, Florida, United States (enrolling)
• Coronavirus Research Institute- Testing Site — Chicago, Illinois, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Baltimore, Maryland, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Bethesda, Maryland, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Boston, Massachusetts, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Detroit, Michigan, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Newark, New Jersey, United States (enrolling)
• Coronavirus Research Institute-Testing Site — New York, New York, United States (enrolling)
• Coronavirus Research Institute-Testing Site- — The Bronx, New York, United States (enrolling)
• Coronavirus Research Institute-Testing Site — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.