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)
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|ClinicalTrials.gov Identifier: NCT04351243|
Recruitment Status : Completed
First Posted : April 17, 2020
Results First Posted : December 10, 2021
Last Update Posted : December 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Gimsilumab Drug: Placebo||Phase 2|
Gimsilumab is a monoclonal antibody against granulocyte macrophage-colony stimulating factor (GM-CSF), which is a myeloid cell growth factor and pro- inflammatory cytokine. Late stages of COVID-19 can be marked by a "cytokine storm" and the overactivation of inflammatory myeloid cells that infiltrate and damage tissue, such as the lungs. Inhibition of GM-CSF may be able to reverse this pathology. The anti-GM-CSF mechanism is distinct from antiviral therapeutic mechanisms and may provide synergistic effects when used in combination.
Study KIN-1901-2001 will consist of a 2-week treatment period (last dose Day 8, if administered) and a 22-week follow-up period, for a total study duration of 24 weeks for each subject. A total of 270 subjects (135 subjects per arm) who have a confirmed diagnosis of COVID-19 with clinical evidence of acute lung injury or ARDS will be entered into the trial.
Subjects will receive a 400 mg dose of gimsilumab on Day 1 and a 200 mg dose of gimsilumab on Day 8, or matching placebo (saline solution) on Day 1 and on Day 8. The Day 8 dose will be omitted if the subject is discharged from the hospital prior to the dose or is no longer in need of supplemental oxygen or ventilatory support for >48 hours.
The primary objective of Study KIN-1901-2001 is to evaluate the impact of IV treatment with gimsilumab on mortality in subjects with lung injury or ARDS secondary to COVID-19.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||April 15, 2020|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||April 1, 2021|
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8
Gimsilumab is a fully human monoclonal antibody (mAb).
Other Name: KIN-1901
Placebo Comparator: Placebo
Normal saline on Day 1 Normal saline on Day 8
- Incidence of Mortality [ Time Frame: Day 43 ]"Incidence" is defined as the percent of subjects that died by Day 43
- Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation [ Time Frame: Day 29 ]
- Number of Ventilator-free Days [ Time Frame: Baseline to Day 29 ]Subjects who die will be assigned "0" ventilator-free days
- Time to Hospital Discharge [ Time Frame: Baseline to Day 43 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351243