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Study of Sargramostim in Patients With COVID-19 (iLeukPulm)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04411680
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : June 21, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Partner Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 29, 2020
First Posted Date  ICMJE June 2, 2020
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE August 18, 2020
Actual Primary Completion Date March 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • Change in oxygenation parameter of P(A-a)O2 gradient by Day 6 [ Time Frame: 1-6 days ]
  • Percent of patients who have been intubated by Day 14 [ Time Frame: 1-14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Change in ordinal scale [ Time Frame: 1-28 days ]
    The 8 point ordinal scale will be used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.
  • All cause 28-day mortality [ Time Frame: 1-28 days ]
  • Number of patients with treatment-emergent serious adverse events or clinically significant adverse drug reactions (ADRs) [ Time Frame: 1-58 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • Change in ordinal scale [ Time Frame: 1-28 days ]
  • All cause 28-day mortality [ Time Frame: 1-28 days ]
  • Number of patients with treatment-emergent serious adverse events or clinically significant adverse drug reactions (ADRs) [ Time Frame: 1-58 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sargramostim in Patients With COVID-19
Official Title  ICMJE A Phase 2 Trial Evaluating Sargramostim in Patients With COVID-19 Associated Acute Hypoxemia
Brief Summary The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from the effects of COVID-19, and this research study will help to find this out.
Detailed Description

This Phase 2 study is designed as a proof of concept study and will randomize 2:1 approximately 120 patients with COVID-19 associated acute hypoxemia: of which 80 patients will receive sargramostim plus standard of care, and 40 patients who will receive standard of care alone. The aim of the study is to determine if inhaled sargramostim, as an adjunct to institutional standard of care, improves clinical outcomes in patients with COVID-19-associated acute hypoxemia. All patients on the sargramostim arm will be treated with 125 mcg inhaled sargramostim twice daily for 5 days, in addition to institutional standard of care. If required, upon progression to an invasive mechanical ventilator, administration of sargramostim may be delivered by intravenous infusion to complete a total of 5 days (including days delivered via inhalation).

GM-CSF is a critical cytokine for healthy pulmonary function and is necessary for the maturation and maintenance of alveolar macrophages. Preclinical studies have shown GM-CSF confers resistance to influenza by enhancing innate immune mechanisms that depend on alveolar macrophages for their health and normal functioning. Clinical studies of sargramostim in patients with severe sepsis and respiratory dysfunction or acute respiratory distress syndrome have shown improvements in oxygenation and lung compliance.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This Phase 2, randomized, open-label study will enroll approximately 120 patients with COVID-19 associated acute hypoxemia. It is a randomized 2:1 study to evaluate sargramostim treatment plus institutional standard of care compared to institutional standard of care alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Sars-CoV2
Intervention  ICMJE
  • Drug: Sargramostim
    Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.
    Other Names:
    • Leukine
    • GM-CSF
  • Drug: Standard of care
    Standard of care for COVID-19
Study Arms  ICMJE
  • Experimental: Sargramostim Arm
    Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19
    Interventions:
    • Drug: Sargramostim
    • Drug: Standard of care
  • Active Comparator: Control Arm
    Standard of care for COVID-19
    Intervention: Drug: Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2021)
122
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2020)
60
Actual Study Completion Date  ICMJE May 19, 2021
Actual Primary Completion Date March 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged ≥ 18 years
  • Patients (or legally authorized decision maker) must provide informed consent
  • Test positive for SARS-CoV-2 virus by PCR
  • Admitted to hospital
  • Presence of acute hypoxemia defined as (either or both)

    • saturation below 93% on ≥ 2 L/min oxygen supplementation
    • PaO2/FiO2 below 350

Exclusion Criteria:

  • Patients requiring invasive (mechanical ventilation) or non-invasive (CPAP, BiPAP for hypoxemia) ventilation or ECMO (Note: oxygen supplementation using high flow oxygen systems or low flow oxygen systems would not exclude patients from this study)
  • Intractable metabolic acidosis
  • Cardiogenic pulmonary edema
  • Hypotension requiring use of vasopressors
  • Hyperferritinemia (serum ferritin ≥2,000 mcg/L)
  • White blood cell count > 50,000/mm3
  • Participation in another interventional clinical trial for COVID-19 therapy
  • Highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24 hours prior to first dose of sargramostim
  • Known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product
  • Previous experience of severe and unexplained side effects during aerosol delivery of any kind of medical product
  • Presence of any preexisting illness that, in the opinion of the Investigator, would place the patient at an unreasonably increased risk through participation in this study
  • Pregnant or breastfeeding females
  • Severe or uncontrolled pulmonary comorbid conditions, including systemic steroid dependent asthma, systemic steroid dependent COPD, oxygen dependent COPD, lung transplant, known interstitial lung disease, or cystic fibrosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04411680
Other Study ID Numbers  ICMJE PTX-001-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Partner Therapeutics, Inc.
Study Sponsor  ICMJE Partner Therapeutics, Inc.
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE Not Provided
PRS Account Partner Therapeutics, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP