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

Primary Purpose

Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drug: NA-831
NA-831 and Atazanavir
NA-831and Dexamethasone
Atazanavir and Dexamethasone
Sponsored by
NeuroActiva, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus Infection focused on measuring NA-831, Atazanavir, Dexamethasone, COVID-19, Coronavirus Infection, Severe Acute Respiratory Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Coronavirus Research Institute- Testing SiteRecruiting
  • Coronavirus Research InstituteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing Site
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute- Testing SiteRecruiting
  • Coronavirus Research Institute-Testing Site
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing Site
  • Coronavirus Research Institute-Testing Site
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing Site-Recruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute- Testing Site
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute- Testing SiteRecruiting
  • Coronavirus Research Institute-Testing Site
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting
  • Coronavirus Research Institute-Testing SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Active Comparator: NA-831 alone

Active Comparator: NA-831 plus Atazanavir Sulfate

Active Comparator: NA-83 plus Dexamethasone

Active Comparator: Atazanavir and Dexamethasone

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2020
Last Updated
January 31, 2022
Sponsor
NeuroActiva, Inc.
Collaborators
Biomed Industries, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04452565
Brief Title
NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroActiva, Inc.
Collaborators
Biomed Industries, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2
Keywords
NA-831, Atazanavir, Dexamethasone, COVID-19, Coronavirus Infection, Severe Acute Respiratory Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: NA-831 alone
Arm Type
Active Comparator
Arm Description
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
Arm Title
Active Comparator: NA-831 plus Atazanavir Sulfate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Comparator: NA-83 plus Dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Comparator: Atazanavir and Dexamethasone
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Drug: NA-831
Intervention Description
NA-831 is a neuroprotective drug, available at 30 mg capsule
Intervention Type
Combination Product
Intervention Name(s)
NA-831 and Atazanavir
Other Intervention Name(s)
and Atazanavir
Intervention Description
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet
Intervention Type
Combination Product
Intervention Name(s)
NA-831and Dexamethasone
Other Intervention Name(s)
Dexamethasone
Intervention Description
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Intervention Type
Combination Product
Intervention Name(s)
Atazanavir and Dexamethasone
Other Intervention Name(s)
Dexamethasone
Intervention Description
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Primary Outcome Measure Information:
Title
1. Time (Hours) to recovery
Description
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
[ Time Frame: 36 days ]
Secondary Outcome Measure Information:
Title
Time fever resolution
Description
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
[ Time Frame: 36 days ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Tran, MD
Phone
800-824-5135
Email
BTran@biomedind.com
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Kennedy, PhD
Phone
800-824-5135
Email
FKennedy@biomedind.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lloyd Tran, PhD
Organizational Affiliation
Biomed Industries, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Coronavirus Research Institute- Testing Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
San Diego
State/Province
California
ZIP/Postal Code
92314
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Testing Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lloyd Tran, PhD
Phone
800-82405135
Email
LTran@biomedind.com
First Name & Middle Initial & Last Name & Degree
Markku Kurkinen, PhD
Phone
800-824-5135
Email
MKurkinen@biomedind.com
Facility Name
Coronavirus Research Institute-Testing Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute- Testing Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site-
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute- Testing Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute- Testing Site
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Name
Coronavirus Research Institute-Testing Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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