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

a study on COVID-19 Acute Respiratory Infection Severe Acute Respiratory Syndrome

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study start
estimated completion

Description

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.

Official Title

Randomized Controlled Phase 2/3 Clinical Trial of NA-831 Alone or With Atazanavir, or NA-831 With Dexamethasone, or Atazanavir With Dexamethasone in the Treatment of COVID-19 Infection

Details

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.

Keywords

Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2, NA-831, Atazanavir, Dexamethasone, COVID-19, Severe Acute Respiratory Syndrome, Infections, Communicable Diseases, Coronavirus Infections, Respiratory Tract Infections, Atazanavir Sulfate, Dexamethasone acetate, BB 1101, Drug: NA-831, NA-831 and Atazanavir, NA-831and Dexamethasone, Atazanavir and Dexamethasone

Eligibility

You can join if…

Open to people ages 18-80

  • 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 CAN'T join 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:
  • 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

Locations

  • Coronavirus Research Institute- Testing Site accepting new patients
    Los Angeles California 90095 United States
  • Coronavirus Research Institute accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NeuroActiva, Inc.
ID
NCT04452565
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 525 study participants
Last Updated