Trial · NCT04351243

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)

NCT04351243, Phase 2, Completed, Kinevant Sciences GmbH; results first posted 2021-12-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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). Trials, record NCT04351243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04351243

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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)
NCT number: NCT04351243
Status: Completed
Phases: Phase 2
Enrollment: 227 participants, actual
Lead sponsor: Kinevant Sciences GmbH
Conditions: COVID-19
Interventions: Gimsilumab, Placebo
First posted: 2020-04-17
Last updated: 2021-12-14
Results first posted: 2021-12-10
Limitations and caveats: The Sponsor stopped enrollment of subjects prior to achieving the planned sample size of 270. At the completion of study enrollment, 227 subjects were randomized and 225 received at least one dose of gimsilumab or placebo. All randomized subjects (227 subjects), where possible, completed all study-related activities and had data collected through the planned Day 43 and Day 169 analyses. No safety findings were observed which warranted study termination.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Mortality	Day 43	"Incidence" is defined as the percent of subjects that died by Day 43
Secondary	Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation	Day 29
Secondary	Number of Ventilator-free Days	Baseline to Day 29	Subjects who die will be assigned "0" ventilator-free days
Secondary	Time to Hospital Discharge	Baseline to Day 43

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Mortality	Day 43	Intent-to-Treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation	Day 29	Intent-to-Treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Ventilator-free Days	Baseline to Day 29	Intent-to-Treat	Days	MEDIAN
SECONDARY	Time to Hospital Discharge	Baseline to Day 43	Intent-to-Treat	Days	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Incidence of Mortality	Gimsilumab	32		Participants
Incidence of Mortality	Placebo	26		Participants
Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation	Gimsilumab	80		Participants
Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation	Placebo	78		Participants
Number of Ventilator-free Days	Gimsilumab	29.0	Inter-Quartile Range 2.0 to 29.0	Days
Number of Ventilator-free Days	Placebo	29.0	Inter-Quartile Range 4.0 to 29.0	Days
Time to Hospital Discharge	Gimsilumab	13.0	95% Confidence Interval 10.0 to 18.0	Days
Time to Hospital Discharge	Placebo	15.0	95% Confidence Interval 9.0 to 19.0	Days

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gimsilumab	114
Overall Study	STARTED	Placebo	113
Overall Study	Completed Baseline Assessment	Gimsilumab	113
Overall Study	Completed Baseline Assessment	Placebo	112
Overall Study	COMPLETED	Gimsilumab	74
Overall Study	COMPLETED	Placebo	75
Overall Study	NOT COMPLETED	Gimsilumab	40
Overall Study	NOT COMPLETED	Placebo	38

Source ClinicalTrials.gov

Adverse events200

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Respiratory failure	Respiratory, thoracic and mediastinal disorders	Gimsilumab	21	113	22
other	Respiratory failure	Respiratory, thoracic and mediastinal disorders	Placebo	20	112	22
other	Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Gimsilumab	6	113	7
other	Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Placebo	6	112	6
other	Pneumothorax	Respiratory, thoracic and mediastinal disorders	Gimsilumab	4	113	4
other	Pneumothorax	Respiratory, thoracic and mediastinal disorders	Placebo	6	112	7
other	Hypoxia	Respiratory, thoracic and mediastinal disorders	Gimsilumab	0	113	0
other	Hypoxia	Respiratory, thoracic and mediastinal disorders	Placebo	6	112	6
other	Septic shock	Infections and infestations	Gimsilumab	8	113	8
other	Septic shock	Infections and infestations	Placebo	8	112	8

1 to 10 of 200Source ClinicalTrials.gov

See all 200 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gimsilumab	32	113
Total, all-cause mortality	Placebo	31	112
Total, other adverse events	Gimsilumab	84	113
Total, other adverse events	Placebo	77	112
Total, serious adverse events	Gimsilumab	47	113
Total, serious adverse events	Placebo	45	112

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35290169	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gimsilumab vs Placebo: Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation	Trial comparisons
Gimsilumab vs Placebo: Incidence of Mortality	Trial comparisons
Gimsilumab vs Placebo: deaths from any cause	Trial comparisons
Gimsilumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04351243

GET https://conductscience.org/api/trials/v1/NCT04351243/events?page=2

API reference For AI assistants