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NCT04348500 · ClinicalTrials.gov registry record · Phase 2
Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT04348500: Completed Phase 2 study, sponsored by Cedars-Sinai Medical Center.
NCT04348500 is a Phase 2 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04348500, a Phase 2 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a single center, randomized, double-blind, placebo-controlled, exploratory phase II study enrolling 60 patients. We propose the administration of a blinded dose of an investigational product (IP) (clazakizumab or placebo \[0.9% saline\]) in patients with COVID-19 disease and signs of pulmonary involvement who have not yet required mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). If a patient progresses to mechanical ventilation and/or ECMO or develops clinical signs of deteriorating COVID-19 disease, and there are no treatment related serious adverse events (SAEs), within the initial 14 day period after the first dose of the IP, at the discretion of the investigator or treating physician, open-label clazakizumab 25mg IV x 1 dose may be administered. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. The patient will remain blinded as to the identity of the IP administered in the first dose.
Primary Outcome
Number of severe adverse events (SAEs) that are unusual, unexpected, or assessed as related to the investigational product (IP)
Interventions
- DRUG Clazakizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-04-28 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 2 |
What the finished NCT04348500 record still lists
NCT04348500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Clazakizumab is the first listed.
NCT04348500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04348500 about?
NCT04348500 is a clinical study titled "Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)". This is a single center, randomized, double-blind, placebo-controlled, exploratory phase II study enrolling 60 patients. We propose the administration of a blinded dose of an investigational product (IP) (clazakizumab or placebo \[0.9% saline\]) in patients with COVID-19 disease and signs of pulmona...
What is the current status of trial NCT04348500?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-04-28. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT04348500?
The interventions under investigation include: Clazakizumab (DRUG).
Who is sponsoring clinical trial NCT04348500?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04348500's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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