At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 212 enrolled
Drug / intervention
Sirukumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease
In Brief
A Phase 2 clinical trial evaluating Sirukumab, Placebo, and 1 other intervention for Critical Confirmed Coronavirus Disease (COVID)-19. Completed, enrolled 212 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartApr 2020
First PostedMay 2020
Primary CompletionApr 2021
Study CompletionJun 2021
TodayJul 2026
First PostedMay 8, 2020
Enrollment StartApr 24, 2020
Primary CompletionApr 9, 2021
Study CompletionJun 24, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.1 years ago
Interventions
Sirukumabdrug
Participants will receive single dose infusion of sirukumab on Day 1.
Placebodrug
Participants will receive placebo IV single dose infusion on Day 1.
Standard of Care (SOC)other
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.