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

Sponsor
NeuroActiva, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04452565
Collaborator
Biomed Industries, Inc. (Industry)
525
31
4
18
16.9
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Drug: NA-831
  • Combination Product: NA-831 and Atazanavir
  • Combination Product: NA-831and Dexamethasone
  • Combination Product: Atazanavir and Dexamethasone
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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

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 Names:
  • 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 Names:
  • 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 Names:
  • Dexamethasone
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    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.

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Coronavirus Research Institute- Testing Site Los Angeles California United States 90095
    2 Coronavirus Research Institute Orange California United States 92868
    3 Coronavirus Research Institute-Testing Site Palo Alto California United States 94304
    4 Coronavirus Research Institute-Testing Site Sacramento California United States 95817
    5 Coronavirus Research Institute-Testing Site San Diego California United States 92314
    6 Coronavirus Research Testing Site San Francisco California United States 94110
    7 Coronavirus Research Institute-Testing Site Sunnyvale California United States 94086
    8 Coronavirus Research Institute-Testing Site Washington District of Columbia United States 20007
    9 Coronavirus Research Institute-Testing Site Washington District of Columbia United States 20010
    10 Coronavirus Research Institute-Testing Site Fort Lauderdale Florida United States 33308
    11 Coronavirus Research Institute-Testing Site Tampa Florida United States 33620
    12 Coronavirus Research Institute- Testing Site Chicago Illinois United States 60612
    13 Coronavirus Research Institute-Testing Site Naperville Illinois United States 60540
    14 Coronavirus Research Institute-Testing Site Baltimore Maryland United States 21287
    15 Coronavirus Research Institute-Testing Site Bethesda Maryland United States 20892
    16 Coronavirus Research Institute-Testing Site Boston Massachusetts United States 02114
    17 Coronavirus Research Institute-Testing Site Worcester Massachusetts United States 01655
    18 Coronavirus Research Institute-Testing Site Ann Arbor Michigan United States 48109
    19 Coronavirus Research Institute-Testing Site Detroit Michigan United States 48202
    20 Coronavirus Research Institute-Testing Site Newark New Jersey United States 07102
    21 Coronavirus Research Institute-Testing Site- Bronx New York United States 10467
    22 Coronavirus Research Institute-Testing Site New York New York United States 10016
    23 Coronavirus Research Institute- Testing Site Rochester New York United States 14642
    24 Coronavirus Research Institute-Testing Site Durham North Carolina United States 27704
    25 Coronavirus Research Institute-Testing Site Philadelphia Pennsylvania United States 19104
    26 Coronavirus Research Institute- Testing Site Fort Sam Houston Texas United States 78234
    27 Coronavirus Research Institute-Testing Site Galveston Texas United States 77555
    28 Coronavirus Research Institute-Testing Site Houston Texas United States 77030
    29 Coronavirus Research Institute-Testing Site Kirkland Washington United States 98034
    30 Coronavirus Research Institute-Testing Site Seattle Washington United States 98104
    31 Coronavirus Research Institute-Testing Site Tacoma Washington United States 98431

    Sponsors and Collaborators

    • NeuroActiva, Inc.
    • Biomed Industries, Inc.

    Investigators

    • Study Director: Lloyd Tran, PhD, Biomed Industries, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NeuroActiva, Inc.
    ClinicalTrials.gov Identifier:
    NCT04452565
    Other Study ID Numbers:
    • NATADEX
    First Posted:
    Jun 30, 2020
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Keywords provided by NeuroActiva, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 16, 2022