Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Tisha Wang, MD (ucla)

Description

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.

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)

Details

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.

Keywords

COVID-19 Granulocyte macrophage-colony stimulating factor (GM-CSF) Immunomodulator Cytokine storm Coronavirus Severe Acute Respiratory Syndrome (SARS) Lung Injury Monoclonal antibody Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Gimsilumab

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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.

Locations

  • UCLA Ronald Reagan Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Banner University Medical Center accepting new patients
    Phoenix Arizona 85006 United States
  • HonorHealth John C. Lincoln Medical Center accepting new patients
    Phoenix Arizona 85020 United States

Lead Scientist at UC Health

  • Tisha Wang, MD (ucla)
    Associate Professor of Clinical , Medicine. Authored (or co-authored) 9 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kinevant Sciences GmbH
ID
NCT04351243
Phase
Phase 2
Study Type
Interventional
Last Updated