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 : Recruiting
First Posted : April 17, 2020
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Injury or Acute Respiratory Distress Syndrome Due to 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 high dose of gimsilumab on Day 1 and a low 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 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)|
|Estimated Enrollment :||270 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 12, 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||March 2021|
Gimsilumab high dose on Day 1 Gimsilumab low dose 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
- Primary endpoint [ Time Frame: 43 days ]Mortality at Day 43
- Number of ventilator-free days. [ Time Frame: Day 43 ]Subjects who die will be assigned "0" ventilator-free days
- Number of days in the ICU [ Time Frame: Day 43 ]
- Number of days of inpatient hospitalization [ Time Frame: Day 43 ]
- Incidence of subjects who are alive and not on mechanical ventilation [ Time Frame: Days 15, 22, 29, and 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
|Contact: Lisa Shermanemail@example.com|