NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection (NATADEX)
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ClinicalTrials.gov Identifier: NCT04452565 |
Recruitment Status :
Recruiting
First Posted : June 30, 2020
Last Update Posted : February 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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Coronavirus Infection Severe Acute Respiratory Infection Severe Acute Respiratory Syndrome Coronavirus 2 | Drug: Drug: NA-831 Combination Product: NA-831 and Atazanavir Combination Product: NA-831and Dexamethasone Combination Product: Atazanavir and Dexamethasone | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 525 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Estimated Study Start Date : | June 15, 2022 |
Estimated Primary Completion Date : | December 15, 2023 |
Estimated Study Completion Date : | December 15, 2023 |

Arm | Intervention/treatment |
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Active Comparator: Active Comparator: NA-831 alone
Arm 1: NA-831 30 mg orally twice a day for one day, followed by 30 mg once day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule
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Drug: Drug: NA-831
NA-831 is a neuroprotective drug, available at 30 mg capsule |
Active Comparator: Active Comparator: NA-831 plus Atazanavir Sulfate
Arm 2: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule. AND Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets. |
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 Other Name: and Atazanavir |
Active Comparator: Active Comparator: NA-83 plus Dexamethasone
Active Comparator: NA-831 30 mg capsule plus Dexamethasone 4 mg Arm 3: NA-831 60 mg orally twice a day for one day, followed by 30 mg once a day for four consecutive days (Five days in total). The drug will be supplied in 30 mg capsule. AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets. |
Combination Product: NA-831and Dexamethasone
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg Other Name: Dexamethasone |
Active Comparator: Active Comparator: Atazanavir and Dexamethasone
Atazanavir 400 mg orally twice a day for one day, followed by 200 mg daily for four consecutive days (five days total). The drug will be supplied in 200 mg tablets. AND Dexamethasone 8 mg orally twice a day for one day, followed by 4 mg daily for four consecutive days (five days total). The drug will be supplied in 4 mg tablets. |
Combination Product: 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
Other Name: Dexamethasone |
- 1. Time (Hours) to recovery [ Time Frame: [ 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
- Time fever resolution [ Time Frame: [ 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452565
Contact: Brian Tran, MD | 800-824-5135 | BTran@biomedind.com | |
Contact: Frank Kennedy, PhD | 800-824-5135 | FKennedy@biomedind.com |

Study Director: | Lloyd Tran, PhD | Biomed Industries, Inc. |
Responsible Party: | NeuroActiva, Inc. |
ClinicalTrials.gov Identifier: | NCT04452565 |
Other Study ID Numbers: |
NATADEX |
First Posted: | June 30, 2020 Key Record Dates |
Last Update Posted: | February 16, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
NA-831 Atazanavir Dexamethasone |
COVID-19 Coronavirus Infection Severe Acute Respiratory Syndrome |
Infections Communicable Diseases COVID-19 Coronavirus Infections Respiratory Tract Infections Severe Acute Respiratory Syndrome Pathologic Processes Disease Attributes Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Atazanavir Sulfate Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |