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

Coronavirus Infection Clinical Trial

— NATADEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452565
• Other study ID #: NATADEX
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 15, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2022
• Source: NeuroActiva, Inc.
• Contact: Brian Tran, MD
• Phone: 800-824-5135
• Email: BTran[@]biomedind.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Infections
• Respiratory Tract Infections
• Severe Acute Respiratory Infection
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

Intervention

Drug:
• Drug: NA-831
NA-831 is a neuroprotective drug, available at 30 mg capsule

Combination Product:
• NA-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
• NA-831and Dexamethasone
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
• Atazanavir and Dexamethasone
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg

Locations

Country	Name	City	State
United States	Coronavirus Research Institute-Testing Site	Ann Arbor	Michigan
United States	Coronavirus Research Institute-Testing Site	Baltimore	Maryland
United States	Coronavirus Research Institute-Testing Site	Bethesda	Maryland
United States	Coronavirus Research Institute-Testing Site	Boston	Massachusetts
United States	Coronavirus Research Institute-Testing Site-	Bronx	New York
United States	Coronavirus Research Institute- Testing Site	Chicago	Illinois
United States	Coronavirus Research Institute-Testing Site	Detroit	Michigan
United States	Coronavirus Research Institute-Testing Site	Durham	North Carolina
United States	Coronavirus Research Institute-Testing Site	Fort Lauderdale	Florida
United States	Coronavirus Research Institute- Testing Site	Fort Sam Houston	Texas
United States	Coronavirus Research Institute-Testing Site	Galveston	Texas
United States	Coronavirus Research Institute-Testing Site	Houston	Texas
United States	Coronavirus Research Institute-Testing Site	Kirkland	Washington
United States	Coronavirus Research Institute- Testing Site	Los Angeles	California
United States	Coronavirus Research Institute-Testing Site	Naperville	Illinois
United States	Coronavirus Research Institute-Testing Site	New York	New York
United States	Coronavirus Research Institute-Testing Site	Newark	New Jersey
United States	Coronavirus Research Institute	Orange	California
United States	Coronavirus Research Institute-Testing Site	Palo Alto	California
United States	Coronavirus Research Institute-Testing Site	Philadelphia	Pennsylvania
United States	Coronavirus Research Institute- Testing Site	Rochester	New York
United States	Coronavirus Research Institute-Testing Site	Sacramento	California
United States	Coronavirus Research Institute-Testing Site	San Diego	California
United States	Coronavirus Research Testing Site	San Francisco	California
United States	Coronavirus Research Institute-Testing Site	Seattle	Washington
United States	Coronavirus Research Institute-Testing Site	Sunnyvale	California
United States	Coronavirus Research Institute-Testing Site	Tacoma	Washington
United States	Coronavirus Research Institute-Testing Site	Tampa	Florida
United States	Coronavirus Research Institute-Testing Site	Washington	District of Columbia
United States	Coronavirus Research Institute-Testing Site	Washington	District of Columbia
United States	Coronavirus Research Institute-Testing Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
NeuroActiva, Inc.	Biomed Industries, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Time (Hours) to recovery	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	[ Time Frame: 36 days ]
Secondary	Time fever resolution	Time to resolution of fever defined as at least 48 hours since last temperature = 38.0°C without the use of fever-reducing medications	[ Time Frame: 36 days ]