Phase 2
N=227
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04351243 ↗Enrolled (actual)
227
Serious AEs
40.9%
Results posted
Dec 2021
Primary outcome: Primary: Incidence of Mortality — 32; 26 Participants — p=0.1885
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gimsilumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kinevant Sciences GmbH
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Mortality |
32; 26 | 0.1885 |
| SECONDARY Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation |
80; 78 | — |
| SECONDARY Number of Ventilator-free Days |
29.0; 29.0 | — |
| SECONDARY Time to Hospital Discharge |
13.0; 15.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant female age ≥18 years, inclusive
- Subject (or legally authorized representative) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other approved clinical testing prior to randomization
- Radiographic evidence of bilateral infiltrates
- Subject requires high-flow oxygen or meets clinical classification for ARDS
- Elevated serum CRP or ferritin
- Subjects who have been treated with convalescent plasma (CP) prior to enrollment are eligible if the subject continues to meet all inclusion criteria at screening
- The use of investigational anti-viral treatment (e.g., remdesivir) is allowed if the subject continues to meet all inclusion criteria at screening
Additional inclusion criteria are detailed in the protocol
Exclusion Criteria
- Evidence of life-threatening dysrhythmia or cardiac arrest on presentation
- Intubated >72 hours
- Absolute neutrophil count 5X upper limit of normal
- eGFR 4 weeks) use of corticosteroids >10mg/day of prednisone or equivalent
- Known or suspected active and untreated TB, HIV, hepatitis B or C infection
Additional exclusion criteria are detailed in the protocol.
Data sourced from ClinicalTrials.gov (NCT04351243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.