Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04381052
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Clazakizumab — DRUG
    Dose is 25mg intravenously over 30 minutes.
  • Placebo — OTHER
    Intravenously administered over 30 minutes.

Study Details

In this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.

Key Dates

Start date
May 18, 2020
Status verified
Apr 2022
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021

Study Design

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

Arms

  • Experimental: Clazakizumab 25 mg
    The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum C-reactive protein (CRP) will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
  • Placebo Comparator: Placebo
    The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.

Primary Outcome Measure

Cumulative Incidence of Serious Adverse Events Associated With Clazakizumab or Placebo [ Time Frame: 60 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical Center / New York Presbyerian HospitalNew YorkNew York10032-

Find similar trials in New York, NY

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Columbia University Medical Center / New York Presbyerian Hospital· New York, NY

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