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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 is a Phase 2 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 17 participants.
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.
Interventions
- DRUG Clazakizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-04-28 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04348500
The ClinicalTrials.gov registry entry for NCT04348500 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Clazakizumab is the first listed.
NCT04348500 reports 0 study locations.
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.
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