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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
Results First Posted : February 18, 2022
Last Update Posted : February 18, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Partner Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Drug: Sargramostim Drug: Standard of care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
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
Official Title: A Phase 2 Trial Evaluating Sargramostim in Patients With COVID-19 Associated Acute Hypoxemia
Actual Study Start Date : August 18, 2020
Actual Primary Completion Date : March 2, 2021
Actual Study Completion Date : May 19, 2021


Arm Intervention/treatment
Experimental: Sargramostim Arm
Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19
Drug: Sargramostim
Sargramostim is a glycosylated, yeast-derived 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

Active Comparator: Control Arm
Standard of care for COVID-19
Drug: Standard of care
Standard of care for COVID-19




Primary Outcome Measures :
  1. Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6 [ Time Frame: 1-6 days ]
    The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.

  2. Number of Patients Who Have Been Intubated by Day 14 [ Time Frame: 1-14 days ]

Secondary Outcome Measures :
  1. Change in Ordinal Scale [ Time Frame: 1-28 days ]
    The ordinal scale was used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.

  2. All Cause 28-day Mortality [ Time Frame: 1-28 days ]
  3. Number of Patients With Treatment-related Adverse Events [ Time Frame: 1-58 days ]
    Number of patients with side effects related to treatment with sargramostim. Patients on the control arm did not receive sargramostim.

  4. Survival Time of Patients [ Time Frame: Day 1-90 ]
  5. Causes of Death [ Time Frame: Day 1-90 ]
  6. Change From Baseline in P/F Ratio [ Time Frame: From Day 1 up to Day 6 ]

    The P/F ratio is a simple way to assess severity of low blood oxygen. It's the ratio of PaO2 (arterial oxygen partial pressure obtained from an arterial blood gas) to FiO2 (fraction of inspired oxygen expressed as a decimal). A normal arterial blood is gas 80 to 100 mm Hg. Normal room air has 21% or 0.21 oxygen. So a "normal" P/F ratio is about 380-475. A high P/F ratio means more oxygen in the bloodstream and a low P/F ratio means less oxygen in the bloodstream.

    This outcome measure compares the improvement (increase) in P/F ratio between treatment arms.


  7. Number of Participants Wtih Nosocomial Infections [ Time Frame: Day 1-90 ]
    Nosocomial infections also referred to as healthcare-associated infections (HAI), are infection(s) acquired during the process of receiving health care that was not present during the time of admission.

  8. Number of Patients Requiring Invasive Mechanical Ventilation [ Time Frame: Day 1-90 ]
    The is the number of patients that needed to be placed on a ventilator.

  9. Duration of Invasive, Non-invasive and Supplemental Oxygen [ Time Frame: Day 1-90 ]
    This endpoint includes duration of any/all types of respiratory support

  10. Duration of Hospitalization [ Time Frame: Day 1-90 ]
  11. Time to Normalization of White Blood Cells and Lymphocytes [ Time Frame: Day 1-90 ]
    Normalization of WBC and lymphocyte count is defined as whether WBC and lymphocyte count results are normal or below normal or above normal ranges at available visits.



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:

  • 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

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): NCT04411680


Locations
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United States, California
St. Jude Medical Center
Fullerton, California, United States, 92835
St. Joseph Hospital of Orange
Orange, California, United States, 92868
California Pacific Medical Center - Van Ness Campus
San Francisco, California, United States, 94109
United States, Maryland
TidalHealth Peninsula Regional, Inc
Salisbury, Maryland, United States, 21801
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
United States, Nebraska
Great Plains Health
North Platte, Nebraska, United States, 69101
United States, New York
Richmond University Medical Center
Staten Island, New York, United States, 10310
United States, North Carolina
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Texas
Memorial Hermann Hospital Affiliated with the University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, United States, 77030
United States, Utah
University of Utah Health
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Partner Therapeutics, Inc.
United States Department of Defense
Investigators
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Study Director: Medical Information Partner Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Partner Therapeutics, Inc.:
Study Protocol  [PDF] December 2, 2020
Statistical Analysis Plan  [PDF] March 17, 2021

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Responsible Party: Partner Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04411680    
Other Study ID Numbers: PTX-001-002
First Posted: June 2, 2020    Key Record Dates
Results First Posted: February 18, 2022
Last Update Posted: February 18, 2022
Last Verified: February 2022
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 Partner Therapeutics, Inc.:
COVID-19
sargramostim
Leukine
rhu-GM-CSF
acute hypoxemia
iLeukPulm
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Sargramostim
Immunologic Factors
Physiological Effects of Drugs