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NCT04494646 · ClinicalTrials.gov registry record · Phase 2
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04494646 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 40 participants.
The verdict
NCT04494646, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This multi-center, double-blind, placebo-controlled, randomized Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in patients hospitalized with confirmed COVID-19. The trial will include approximately 40 patients and is designed to provide an early interim analysis of safety. Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo and treatment will be administered for the duration of hospitalization (until recovery), with a maximum treatment duration of 29 days.
Interventions
- DRUG Placebo
- DRUG Bardoxolone Methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-09-08 |
| Est. Completion | 2021-01-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04494646
The ClinicalTrials.gov registry entry for NCT04494646 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04494646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04494646 about?
NCT04494646 is a clinical study titled "BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)". This multi-center, double-blind, placebo-controlled, randomized Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in patients hospitalized with confirmed COVID-19. The trial will include approximately 40 patients and is designed to provide an early interim analysi...
What is the current status of trial NCT04494646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-09-08. Estimated completion is 2021-01-08.
What interventions are being tested in trial NCT04494646?
The interventions under investigation include: Placebo (DRUG), Bardoxolone Methyl (DRUG).
Who is sponsoring clinical trial NCT04494646?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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