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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 : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
NeuroActiva, Inc.

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date July 13, 2020
Estimated Study Start Date  ICMJE August 15, 2020
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection
Official Title  ICMJE 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
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. Data from
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronavirus Infection
  • Severe Acute Respiratory Infection
  • Severe Acute Respiratory Syndrome Coronavirus 2
Intervention  ICMJE
  • 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

    Other Name: and Atazanavir
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Drug: NA-831
  • 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.

    Intervention: Combination Product: NA-831 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.

    Intervention: Combination Product: NA-831and 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.

    Intervention: Combination Product: Atazanavir and Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
525
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2021
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brian Tran, MD 1-415-941-3133 BTran@neuroactiva.com
Contact: Frank Kennedy, PhD 1-415-941-3133 FKennedy@neuroactiva.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452565
Other Study ID Numbers  ICMJE NATADEX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NeuroActiva, Inc.
Study Sponsor  ICMJE NeuroActiva, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lloyd Tran, PhD NeuroActiva, Inc.
PRS Account NeuroActiva, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP