COVID-19Phase 2NCT04351243
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)
A Phase 2 study testing Gimsilumab in people with COVID-19, run by Kinevant Sciences GmbH at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Gimsilumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 33 sitesUnited States
- Study dates
- 15 Apr 2020to 1 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Evidence of life-threatening dysrhythmia or cardiac arrest on presentation
- Intubated >72 hours
- Absolute neutrophil count < 1,000 per mm3
- Platelet count < 50,000 per mm3
- AST or ALT > 5X upper limit of normal
- eGFR <30 mL/min/1.73m2 or requiring hemofiltration or dialysis
Show all 12Show fewer
- History of known anti-GM-CSF autoantibodies or pulmonary alveolar proteinosis
- Severe chronic respiratory disease (e.g., COPD, PAH, IPF, ILD) requiring supplemental oxygen therapy or mechanical ventilation pre-hospitalization (e.g., prior to COVID-19 diagnosis)
- Use of any immunomodulatory biologic, cell therapy, or small molecule JAK inhibitor within past 7 days or 5 half lives or planned use of any of these agents unless approved by medical monitor
- Chronic (>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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Piedmont Healthcare
Atlanta, Georgia, 30309
Emory University School of Medicine
Atlanta, Georgia, 30322
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Baylor Jack & Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226
Baylor University Medical Center
Dallas, Texas, 75246
NorthShore University HealthSystem
Evanston, Illinois, 60201
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 75061
University of Florida
Gainesville, Florida, 32610
Memorial Hermann Hospital Affiliated with University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, 77030
Baylor Scott & White Medical Center
Irving, Texas, 75061
Jamaica Hospital Medical Center
Jamaica, New York, 11418
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
East Jefferson General Hospital
Metairie, Louisiana, 70006
Miami Cancer institute
Miami, Florida, 33176
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Beth Israel
New York, New York, 10003
Mount Sinai West
New York, New York, 10019
Mount Sinai Morningside
New York, New York, 10025
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Banner University Medical Center
Phoenix, Arizona, 85006
HonorHealth John C. Lincoln Medical Center
Phoenix, Arizona, 85020
Baylor Scott & White Heart Hospital
Plano, Texas, 75093
Baylor Scott & White Medical Center
Plano, Texas, 75093
Baylor Scott & White Medical Center
Round Rock, Texas, 78665
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
HonorHealth
Scottsdale, Arizona, 85258
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
Baylor Scott & White Medical Center
Temple, Texas, 76508
Banner University Medical Center
Tucson, Arizona, 85719
About this study
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)
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.
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- Gimsilumab, Placebo
- Keywords
- Granulocyte macrophage-colony stimulating factor (GM-CSF), Immunomodulator, Cytokine storm, COVID-19, Coronavirus, Severe Acute Respiratory Syndrome (SARS), Lung Injury, Monoclonal antibody
- Medical subject headings
- COVID-19, Cytokine Release Syndrome, Coronavirus Infections, Severe Acute Respiratory Syndrome, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GimsilumabDrug
Also called KIN-1901
Gimsilumab is a fully human monoclonal antibody (mAb).
PlaceboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Gimsilumab | Experimental | Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Receives: Drug: Gimsilumab |
| Placebo | Placebo comparator | Normal saline on Day 1 Normal saline on Day 8 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Mortality
"Incidence" is defined as the percent of subjects that died by Day 43
Measured: Day 43
Secondary outcomes (3)
Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation
Measured: Day 29
Number of Ventilator-free Days
Subjects who die will be assigned "0" ventilator-free days
Measured: Baseline to Day 29
Time to Hospital Discharge
Measured: Baseline to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start15 Apr 2020
- Primary completion1 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinevant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roivant Sciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351243
- Sponsor's protocol ID
- KIN-1901-2001
- Status last verified
- Dec 2021
- First submitted
- 15 Apr 2020
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Criner GJ, Lang FM, Gottlieb RL, Mathews KS, Wang TS, Rice TW, Madduri D, Bellam S, Jeanfreau R, Case AH, Glassberg MK, Lyon GM, Ahmad K, Mendelson R, DiMaio JM, Tran MP, Spak CW, Abbasi JA, Davis SG, Ghamande S, Shen S, Sherman L, Lowry S. Anti-Granulocyte-Macrophage Colony-Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1290-1299. doi: 10.1164/rccm.202108-1859OC.
PubMed 35290169
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04351243
- Acronym / sponsor ID
- KIN-1901-2001
- Conditions
- COVID-19
- Keywords
- Granulocyte macrophage-colony stimulating factor (GM-CSF), Immunomodulator, Cytokine storm, COVID-19, Coronavirus, Severe Acute Respiratory Syndrome (SARS), Lung Injury, Monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Kinevant Sciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Roivant Sciences, Inc.
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Posted 10 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gimsilumab | Experimental | Drug: GimsilumabGimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline on Day 1 Normal saline on Day 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- Evidence of life-threatening dysrhythmia or cardiac arrest on presentation
- Intubated >72 hours
- Absolute neutrophil count < 1,000 per mm3
- Platelet count < 50,000 per mm3
- AST or ALT > 5X upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GimsilumabAlso: KIN-1901Gimsilumab is a fully human monoclonal antibody (mAb). | Drug | Gimsilumab |
| PlaceboNormal saline | Drug | Placebo |
Primary outcome
Incidence of Mortality
Time frame: Day 43
"Incidence" is defined as the percent of subjects that died by Day 43
3 secondary outcomes
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
Time to Hospital Discharge
Time frame: Baseline to Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35290169Criner GJ, Lang FM, Gottlieb RL, Mathews KS, Wang TS, Rice TW, Madduri D, Bellam S, Jeanfreau R, Case AH, Glassberg MK, Lyon GM, Ahmad K, Mendelson R, DiMaio JM, Tran MP, Spak CW, Abbasi JA, Davis SG, Ghamande S, Shen S, Sherman L, Lowry S. Anti-Granulocyte-Macrophage Colony-Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1290-1299. doi: 10.1164/rccm.202108-1859OC.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gimsilumab in people with COVID-19, run by Kinevant Sciences GmbH at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Mortality (time frame: Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.