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

  • STATUS
    Recruiting
  • days left to enroll
    20
  • participants needed
    525
  • sponsor
    NeuroActiva, Inc.
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Updated on 25 January 2021
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mechanical ventilation
critical illness
covid-19
SARS
dexamethasone

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.

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, 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. Data from

Details
Treatment Drug: NA-831, NA-831 and Atazanavir, NA-831and Dexamethasone, Atazanavir and Dexamethasone
Clinical Study IdentifierNCT04452565
SponsorNeuroActiva, Inc.
Last Modified on25 January 2021

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Severe Acute Respiratory Infection or Coronavirus Infection or Severe Acute Respiratory Syndrome Coronavirus 2?
Do you have any of these conditions: severe acute respiratory infection (sari) or Coronavirus Infection or Severe Acute Respiratory Syndrome Coronavirus 2 or Severe Acute Respiratory Infe...?
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
Clear my responses
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