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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. 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: NCT04411680
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : August 21, 2020
Sponsor:
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-CoV2 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 60 patients with COVID-19 associated acute hypoxemia: of which 40 patients will receive sargramostim plus standard of care, and 20 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)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This Phase 2, randomized, open-label study will enroll approximately 60 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
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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 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 ]
  2. Percent 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 8 point ordinal scale will be 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-emergent serious adverse events or clinically significant adverse drug reactions (ADRs) [ Time Frame: 1-58 days ]


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
  • 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 minimal (≥ 2 L/min) oxygen supplementation
    • PaO2/FiO2 below 350

Exclusion Criteria:

  • Intubated and supported by mechanical ventilation
  • 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

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


Contacts
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Contact: Fiona Garner, PhD (781)819-4949 ext 1588 ileukpulmstudy@partnertx.com

Locations
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United States, Utah
University of Utah Health Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Robert Paine, MD         
Sponsors and Collaborators
Partner Therapeutics, Inc.
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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
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
GM-CSF
acute hypoxemia
iLeukPulm
Sars-CoV2
Additional relevant MeSH terms:
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Sargramostim
Immunologic Factors
Physiological Effects of Drugs