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Protease Inhibitor

Combination Therapy for COVID-19 (NATADEX Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by NeuroActiva, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [ time frame: 36 days ]
Awards & highlights

NATADEX Trial Summary

This trial is testing different combinations of drugs to see which is most effective in treating people with SARS-CoV-2 who are hospitalized but not critically ill.

Who is the study for?
This trial is for non-critically ill adults hospitalized with COVID-19 who aren't on mechanical ventilation. They must have recent blood tests, a positive SARS CoV-2 test, and an ECG. Participants of childbearing potential must use contraception. Exclusions include allergies to the drugs tested, other investigational treatments, severe medical conditions like heart or kidney disease, pregnancy, breastfeeding, and certain abnormal blood test results.Check my eligibility
What is being tested?
The study compares four treatment combinations for COVID-19: NA-831 alone; NA-831 with Atazanavir; NA-831 with Dexamethasone; and Atazanavir with Dexamethasone. It aims to determine which combination is most effective in non-critical hospitalized patients.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medications used in the trial (NA-831, Atazanavir or Dexamethasone), drug interactions leading to heart rhythm problems or liver issues indicated by elevated AST/ALT levels. Other risks could be related to low magnesium or calcium levels.

NATADEX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[ time frame: 36 days ]
This trial's timeline: 3 weeks for screening, Varies for treatment, and [ time frame: 36 days ] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. Time (Hours) to recovery
Secondary outcome measures
Time fever resolution

NATADEX Trial Design

4Treatment groups
Active Control
Group I: Active Comparator: Atazanavir and DexamethasoneActive Control1 Intervention
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.
Group II: Active Comparator: NA-831 plus Atazanavir SulfateActive Control1 Intervention
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.
Group III: Active Comparator: NA-83 plus DexamethasoneActive Control1 Intervention
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.
Group IV: Active Comparator: NA-831 aloneActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

NeuroActiva, Inc.Lead Sponsor
3 Previous Clinical Trials
3,771 Total Patients Enrolled
Biomed Industries, Inc.Industry Sponsor
1 Previous Clinical Trials
3,600 Total Patients Enrolled
Lloyd Tran, PhDStudy DirectorBiomed Industries, Inc.
3 Previous Clinical Trials
3,771 Total Patients Enrolled

Media Library

Coronavirus Research Study Groups: Active Comparator: Atazanavir and Dexamethasone, Active Comparator: NA-831 plus Atazanavir Sulfate, Active Comparator: NA-83 plus Dexamethasone, Active Comparator: NA-831 alone

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots left for subjects in this experiment?

"This study, as seen on clinicaltrials.gov, is looking for participants. The listing was first published on 6/15/2022 and was updated on 1/31/2022."

Answered by AI

Are there other ongoing studies that are using the drug combination of NA-831 and Atazanavir Sulfate?

"The active comparator in this case is NA-831 plus Atazanavir Sulfate, which was first studied in 2002. As of now, 1224 trials have been completed with 581 still active. Many of these active studies are based in Fort Sam Houston and District of Columbia."

Answered by AI

If I meet the requirements, may I enroll in this experiment?

"This clinical study is looking for 525 participants who have contracted SARS-CoV-2 and are between 18 and 80 years old."

Answered by AI

Are middle-aged adults part of the research group for this experiment?

"The age range for participants in this clinical trial is 18 to 80 years old."

Answered by AI

What do doctors most commonly prescribe Active Comparator: NA-831 plus Atazanavir Sulfate for?

"The active comparator in this study is NA-831 plus Atazanavir Sulfate, which is typically used to treat ophthalmia, sympathetic. However, it has also been shown to be effective in managing branch retinal vein occlusion, macular edema, communicable diseases."

Answered by AI

How many staff locations are responsible for this clinical trial's administration?

"With 30 available options, patients can choose from a variety of coronavirus research institute clinical trial sites, including locations in Fort Sam Houston, Washington, and San Diego."

Answered by AI

Who else is applying?

What state do they live in?
New York
Illinois
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
What site did they apply to?
Coronavirus Research Institute

Why did patients apply to this trial?

Just want to feel beter. I believe I lost my mother to COVID and I dont want it to happen to anybody else.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Is transportation offered and compensation?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection
2022. "NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04452565.
All > Covid
~185 spots leftby Apr 2025
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