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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351243
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
Roivant Sciences, Inc.
Information provided by (Responsible Party):
Kinevant Sciences GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Gimsilumab Drug: Placebo Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Gimsilumab
Gimsilumab high dose on Day 1 Gimsilumab low dose on Day 8
Drug: Gimsilumab
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
Drug: Placebo
Normal saline




Primary Outcome Measures :
  1. Incidence of mortality [ Time Frame: Day 43 ]

Secondary Outcome Measures :
  1. Incidence of subjects who are alive and not on mechanical ventilation [ Time Frame: Day 29 ]
  2. Number of ventilator-free days [ Time Frame: Baseline to Day 29 ]
    Subjects who die will be assigned "0" ventilator-free days

  3. Time to hospital discharge [ Time Frame: Baseline to Day 43 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant female age ≥18 years, inclusive
  2. 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
  3. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other approved clinical testing prior to randomization
  4. Radiographic evidence of bilateral infiltrates
  5. Subject requires high-flow oxygen or meets clinical classification for ARDS
  6. Elevated serum CRP or ferritin
  7. Subjects who have been treated with convalescent plasma prior to enrollment are eligible if the subject continues to meet all entry criteria at screening
  8. The use of investigational antiviral treatments (e.g., remdesivir, hydroxychloroquine) is allowed during the study

Additional inclusion criteria are detailed in the protocol

Exclusion Criteria:

  1. Evidence of life-threatening dysrhythmia or cardiac arrest on presentation
  2. Intubated >72 hours
  3. Absolute neutrophil count < 1,000 per mm3
  4. Platelet count < 50,000 per mm3
  5. AST or ALT > 5X upper limit of normal
  6. eGFR <30 mL/min/1.73m2 or requiring hemofiltration or dialysis
  7. History of known anti-GM-CSF autoantibodies or pulmonary alveolar proteinosis
  8. 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)
  9. Known or suspected active and untreated TB, HIV, hepatitis B or C infection

Additional exclusion criteria are detailed in the protocol.


Information from the National Library of Medicine

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


Contacts
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Contact: Lisa Sherman 832-592-3466 lisa.sherman@roivant.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Kinevant Sciences GmbH
Roivant Sciences, Inc.
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Responsible Party: Kinevant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04351243    
Other Study ID Numbers: KIN-1901-2001
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kinevant Sciences GmbH:
Granulocyte macrophage-colony stimulating factor (GM-CSF)
Immunomodulator
Cytokine storm
COVID-19
Coronavirus
Severe Acute Respiratory Syndrome (SARS)
Lung Injury
Monoclonal antibody
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries