Official Title
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.

Completed
COVID-19
SARS-CoV-2

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 Name: Array

Drug: Standard of care

Standard of care for COVID-19

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

St. Jude Medical Center
Fullerton, California, United States

St. Joseph Hospital of Orange
Orange, California, United States

California Pacific Medical Center - Van Ness Campus
San Francisco, California, United States

TidalHealth Peninsula Regional, Inc
Salisbury, Maryland, United States

University of Missouri Health Care
Columbia, Missouri, United States

Great Plains Health
North Platte, Nebraska, United States

Richmond University Medical Center
Staten Island, New York, United States

Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States

University of Toledo Medical Center
Toledo, Ohio, United States

Memorial Hermann Hospital Affiliated with the University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, United States

University of Utah Health
Salt Lake City, Utah, United States

Medical Information, Study Director
Partner Therapeutics, Inc.

United States Department of Defense
NCT Number
Keywords
Covid-19
sargramostim
Leukine
rhu-GM-CSF
Acute Hypoxemia
iLeukPulm
SARS-CoV-2
MeSH Terms
COVID-19
Sargramostim