Study of Sargramostim in Patients With COVID-19

NCT04411680 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PTX-001-002
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 11

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.

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19; sargramostim; Leukine; rhu-GM-CSF; acute hypoxemia; iLeukPulm; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6

  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.

  1-6 days

• Number of Patients Who Have Been Intubated by Day 14

  1-14 days

Secondary Outcomes (11)

• Change in Ordinal Scale

  1-28 days

• All Cause 28-day Mortality

  1-28 days

• Number of Patients With Treatment-related Adverse Events

  1-58 days

• Survival Time of Patients

  Day 1-90

• Causes of Death

  Day 1-90

Study Arms (2)

Sargramostim Arm

EXPERIMENTAL

Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19

Drug: Sargramostim; Drug: Standard of care

Control Arm

ACTIVE COMPARATOR

Standard of care for COVID-19

Drug: Standard of care

Interventions

Sargramostim DRUG

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.

Also known as: Leukine, GM-CSF

Sargramostim Arm

Standard of care DRUG

Standard of care for COVID-19

Control Arm; Sargramostim Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Partner Therapeutics, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (11)

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

California Pacific Medical Center - Van Ness Campus

San Francisco, California, 94109, United States

Location

TidalHealth Peninsula Regional, Inc

Salisbury, Maryland, 21801, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Great Plains Health

North Platte, Nebraska, 69101, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

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

Houston, Texas, 77030, United States

Location

University of Utah Health

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Paine R, Chasse R, Halstead ES, Nfonoyim J, Park DJ, Byun T, Patel B, Molina-Pallete G, Harris ES, Garner F, Simms L, Ahuja S, McManus JL, Roychowdhury DF. Inhaled Sargramostim (Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor) for COVID-19-Associated Acute Hypoxemia: Results of the Phase 2, Randomized, Open-Label Trial (iLeukPulm). Mil Med. 2023 Jul 22;188(7-8):e2629-e2638. doi: 10.1093/milmed/usac362.

  PMID: 36458916 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Limitations include lack of a blinded placebo control and reliance on ABG measurement for estimation of P(A-a)O2 gradient. Some clinical endpoints trial might have been affected by observer bias, availability of hospital or ICU resources, and/or hospital discharge. Missing ABG measurements may have resulted from decreased standard utilization of ABG in recent years, and hospital staff overload due to the COVID-19 pandemic may have led to absent follow-up assessment.

Results Point of Contact

• Title: Medical Information
• Organization: Partner Therapeutics, Inc.

PartnerTx@medcomminc.com

1-888-479-5385

Study Officials

• Medical Information

  Partner Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: August 18, 2020
• Primary Completion: March 2, 2021
• Study Completion: May 19, 2021
• Last Updated: August 23, 2023
• Results First Posted: February 18, 2022

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)