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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.

Study Description
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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
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

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 Design
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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 : August 15, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
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Information from the National Library of Medicine

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


Contacts
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Contact: Brian Tran, MD 1-415-941-3133 BTran@neuroactiva.com
Contact: Frank Kennedy, PhD 1-415-941-3133 FKennedy@neuroactiva.com

Locations
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Sponsors and Collaborators
NeuroActiva, Inc.
Investigators
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Study Director: Lloyd Tran, PhD NeuroActiva, Inc.
More Information
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Responsible Party: NeuroActiva, Inc.
ClinicalTrials.gov Identifier: NCT04452565    
Other Study ID Numbers: NATADEX
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
NA-831
Atazanavir
Dexamethasone
 COVID-19
Coronavirus Infection
Severe Acute Respiratory Syndrome
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus 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
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Anti-HIV Agents