Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT04348500
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 28, 2020
Status verified
Feb 2024
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020

Study Design

Enrollment
17 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Clazakizumab
    25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes
  • Placebo Comparator: Placebo
    50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes

Primary Outcome Measure

Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-

Find similar trials in Los Angeles, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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