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NCT04343989 · ClinicalTrials.gov registry record · Phase 2
A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
A Phase 2 study of COVID-19, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 178
- Enrollment target
- 3
- Study locations
NCT04343989: Completed Phase 2 study of COVID-19, sponsored by NYU Langone Health.
NCT04343989 is a Phase 2 study of COVID-19 that has completed, run by NYU Langone Health. The registered enrollment target is 178 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04343989, a Phase 2 study of COVID-19, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 178 participants
- Enrollment target
- 3
- Study locations
Study Summary
In this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a double-blinded randomized multi-center trial designed as a phase II dose-finding three arm trial with seamless adaptive transition to a phase III efficacy trial. For phase II, patients were randomized 1:1:1 ratio to three study arms and received clazakizumab at a dose of 12.5 mg, 25 mg or placebo. Based on interim analysis, the low dose arm was dropped and the phase III portion of the study continued to enroll patients randomized 1:1 to high dose clazakizumab or placebo. Based on interim analysis, the remaining 10 subjects at NYU will be randomly assigned to a 1:1 ratio to two arms that will receive clazakizumab at a dose of 25 mg or placebo. The NYU site will serve as the central data management site for other centers who undertake this protocol. Other sites will enroll patients based on the two arm 1:1 randomization. 60 patients at outside sites are expected to enroll.
Primary Outcome
Ventilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Clazakizumab 25 mg
- DRUG Clazakizumab 12.5 mg
Study Locations (3)
Arizona
- Mayo Clinic - Phoenix
Maryland
- The Johns Hopkins Hospital - Baltimore
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2021-03-12 |
| Phase | Phase 2 |
What the finished NCT04343989 record still lists
NCT04343989 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04343989 reports a single indexed study location in Arizona, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT04343989 about?
NCT04343989 is a clinical study titled "A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection". In this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a double-blinded randomized multi-center trial designed as a phase II dose-findin...
What is the current status of trial NCT04343989?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2020-03-31. Estimated completion is 2021-03-12.
What conditions does trial NCT04343989 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04343989?
The interventions under investigation include: Placebo (OTHER), Clazakizumab 25 mg (DRUG), Clazakizumab 12.5 mg (DRUG).
Who is sponsoring clinical trial NCT04343989?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04343989 being conducted?
This trial has 3 study locations across Arizona, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04343989's enrollment target sits among peer trials
178 164th of 298 higher than 135 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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