Coronavirus InfectionPhase 2/3NATADEXNCT04452565
NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection
A Phase 2/3 study testing Drug: NA-831, NA-831 and Atazanavir and NA-831and Dexamethasone in people with Coronavirus Infection and Severe Acute Respiratory Infection, run by Biomed Industries, Inc. at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Drug: NA-831, NA-831 and Atazanavir and NA-831and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 31 sitesUnited States
- Study dates
- 15 Jun 2022to 15 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites, 31 recruiting
- Not yet recruiting
Coronavirus Research Institute-Testing Site
Ann Arbor, Michigan, 48109
- Recruiting
Coronavirus Research Institute-Testing Site
Baltimore, Maryland, 21287
- Recruiting
Coronavirus Research Institute-Testing Site
Bethesda, Maryland, 20892
- Recruiting
Coronavirus Research Institute-Testing Site
Boston, Massachusetts, 02114
- Recruiting
Coronavirus Research Institute- Testing Site
Chicago, Illinois, 60612
- Recruiting
Coronavirus Research Institute-Testing Site
Detroit, Michigan, 48202
- Recruiting
Coronavirus Research Institute-Testing Site
Durham, North Carolina, 27704
- Recruiting
Coronavirus Research Institute-Testing Site
Fort Lauderdale, Florida, 33308
- Recruiting
Coronavirus Research Institute- Testing Site
Fort Sam Houston, Texas, 78234
- Not yet recruiting
Coronavirus Research Institute-Testing Site
Galveston, Texas, 77555
- Recruiting
Coronavirus Research Institute-Testing Site
Houston, Texas, 77030
- Recruiting
Coronavirus Research Institute-Testing Site
Kirkland, Washington, 98034
- Recruiting
Coronavirus Research Institute- Testing Site
Los Angeles, California, 90095
- Not yet recruiting
Coronavirus Research Institute-Testing Site
Naperville, Illinois, 60540
- Recruiting
Coronavirus Research Institute-Testing Site
New York, New York, 10016
- Recruiting
Coronavirus Research Institute-Testing Site
Newark, New Jersey, 07102
- Recruiting
Coronavirus Research Institute
Orange, California, 92868
- Recruiting
Coronavirus Research Institute-Testing Site
Palo Alto, California, 94304
- Recruiting
Coronavirus Research Institute-Testing Site
Philadelphia, Pennsylvania, 19104
- Not yet recruiting
Coronavirus Research Institute- Testing Site
Rochester, New York, 14642
- Recruiting
Coronavirus Research Institute-Testing Site
Sacramento, California, 95817
- Recruiting
Coronavirus Research Institute-Testing Site
San Diego, California, 92314
- Recruiting
Coronavirus Research Testing Site
San Francisco, California, 94110
- Recruiting
Coronavirus Research Institute-Testing Site
Seattle, Washington, 98104
- Recruiting
Coronavirus Research Institute-Testing Site
Sunnyvale, California, 94086
Lloyd Tran, PhD, 800-82405135, LTran@biomedind.com
Markku Kurkinen, PhD, 800-824-5135, MKurkinen@biomedind.com
- Recruiting
Coronavirus Research Institute-Testing Site
Tacoma, Washington, 98431
- Recruiting
Coronavirus Research Institute-Testing Site
Tampa, Florida, 33620
- Recruiting
Coronavirus Research Institute-Testing Site-
The Bronx, New York, 10467
- Recruiting
Coronavirus Research Institute-Testing Site
Washington D.C., District of Columbia, 20007
- Not yet recruiting
Coronavirus Research Institute-Testing Site
Washington D.C., District of Columbia, 20010
- Not yet recruiting
Coronavirus Research Institute-Testing Site
Worcester, Massachusetts, 01655
About this study
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
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.
Read the 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.
- Conditions
- Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2
- Being tested
- Drug: NA-831, NA-831 and Atazanavir, NA-831and Dexamethasone, Atazanavir and Dexamethasone
- Keywords
- NA-831, Atazanavir, Dexamethasone, COVID-19, Coronavirus Infection, Severe Acute Respiratory Syndrome
- Medical subject headings
- Coronavirus Infections, COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: NA-831Drug
NA-831 is a neuroprotective drug, available at 30 mg capsule
NA-831 and AtazanavirCombination product
Also called 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
NA-831and DexamethasoneCombination product
Also called Dexamethasone
Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule
Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
Atazanavir and DexamethasoneCombination product
Also called Dexamethasone
Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: NA-831 alone | Active comparator | 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 Receives: Drug: Drug: NA-831 |
| Active Comparator: NA-831 plus Atazanavir Sulfate | Active comparator | 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. Receives: Combination Product: NA-831 and Atazanavir |
| Active Comparator: NA-83 plus Dexamethasone | Active comparator | 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. Receives: Combination Product: NA-831and Dexamethasone |
| Active Comparator: Atazanavir and Dexamethasone | Active comparator | 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. Receives: Combination Product: Atazanavir and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [ Time Frame: 36 days ]
Secondary outcomes (1)
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
Measured: [ Time Frame: 36 days ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start15 Jun 2022 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomed Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lloyd Tran, PhD, Study director, Biomed Industries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452565
- Sponsor's protocol ID
- NATADEX
- Acronym
- NATADEX
- Status last verified
- Jan 2022
- First submitted
- 26 Jun 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04452565
- Acronym / sponsor ID
- NATADEX / NATADEX
- Conditions
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Biomed Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: NA-831 alone | Active comparator | Drug: Drug: NA-831Arm 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 |
| Active Comparator: NA-831 plus Atazanavir Sulfate | Active comparator | Combination Product: NA-831 and AtazanavirArm 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-83 plus Dexamethasone | Active comparator | Combination Product: NA-831and DexamethasoneActive 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. |
| Active Comparator: Atazanavir and Dexamethasone | Active comparator | Combination Product: Atazanavir and DexamethasoneAtazanavir 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (24 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: NA-831NA-831 is a neuroprotective drug, available at 30 mg capsule | Drug | Active Comparator: NA-831 alone |
| NA-831 and AtazanavirAlso: and AtazanavirDrug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet | Combination product | Active Comparator: NA-831 plus Atazanavir Sulfate |
| NA-831and DexamethasoneAlso: DexamethasoneDrug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg | Combination product | Active Comparator: NA-83 plus Dexamethasone |
| Atazanavir and DexamethasoneAlso: DexamethasoneDrug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg | Combination product | Active Comparator: Atazanavir and Dexamethasone |
Primary outcome
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
1 secondary outcome
Time fever resolution
Time frame: [ Time Frame: 36 days ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lloyd Tran, PhD study director
Biomed Industries, Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Drug: NA-831, NA-831 and Atazanavir and NA-831and Dexamethasone in people with Coronavirus Infection and Severe Acute Respiratory Infection, run by Biomed Industries, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Tran, MD (800-824-5135, BTran@biomedind.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Time (Hours) to recovery (time frame: [ Time Frame: 36 days ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.