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A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19

NCT04380961 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2022-06-21

Study results available
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Summary

The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.

Conditions

  • Critical Confirmed Coronavirus Disease (COVID)-19

Interventions

DRUG

Sirukumab

Participants will receive single dose infusion of sirukumab on Day 1.

DRUG

Placebo

Participants will receive placebo IV single dose infusion on Day 1.

OTHER

Standard of Care (SOC)

SOC treatment will be determined by the investigator based on local practice and consists of supportive care.

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V., Belgium Clinical Trial · Janssen Pharmaceutica N.V., Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2021-04-09
Completion
2021-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380961 on ClinicalTrials.gov