Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • KIN-1901
Placebo Comparator
Placebo
Normal saline on Day 1 Normal saline on Day 8
  • Drug: Placebo
    Normal saline

Recruiting Locations

Memorial Hermann Hospital Affiliated with University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas 77030
Contact:
Bela Patel, MD

More Details

Status
Recruiting
Sponsor
Kinevant Sciences GmbH

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.