At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 227 enrolled
Drug / intervention
Gimsilumab +1 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.
A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
In Brief
A Phase 2 clinical trial evaluating Gimsilumab and Placebo for COVID-19. Completed, enrolled 227 participants across 33 sites.
Detailed Summary
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
CollaboratorsRoivant Sciences, Inc.
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartApr 2020
First PostedApr 2020
Primary CompletionDec 2020
Study CompletionApr 2021
TodayJul 2026
First PostedApr 17, 2020
Enrollment StartApr 15, 2020
Primary CompletionDec 1, 2020
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.2 years ago
Interventions
Gimsilumabdrug
Gimsilumab is a fully human monoclonal antibody (mAb).
Placebodrug
Normal saline