Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2
Conditions
Keywords
NA-831, Atazanavir, Dexamethasone, COVID-19, Coronavirus Infection, Severe Acute Respiratory Syndrome
Brief 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.
Detailed 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.
Interventions
DRUGDrug: NA-831
NA-831 is a neuroprotective drug, available at 30 mg capsule
COMBINATION_PRODUCTNA-831 and Atazanavir
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet
COMBINATION_PRODUCTNA-831and Dexamethasone
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
COMBINATION_PRODUCTAtazanavir and Dexamethasone
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Sponsors
Biomed Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Time (Hours) to recovery | [ Time Frame: 36 days ] | Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time fever resolution | [ Time Frame: 36 days ] | Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications |
Countries
United States
Contacts
Primary ContactBrian Tran, MD
Backup ContactFrank Kennedy, PhD
Outcome results
None listed