COVID-19Phase 2iLeukPulmNCT04411680

Study of Sargramostim in Patients With COVID-19

A Phase 2 study testing Sargramostim in people with COVID-19 and SARS-CoV-2, run by Partner Therapeutics, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19, SARS-CoV-2
What is being tested?: Sargramostim
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 11 sitesUnited States
Study dates: 18 Aug 2020to 19 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

University of Missouri Health Care
Columbia, Missouri, 65212
St. Jude Medical Center
Fullerton, California, 92835
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
Memorial Hermann Hospital Affiliated with the University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, 77030
Great Plains Health
North Platte, Nebraska, 69101
St. Joseph Hospital of Orange
Orange, California, 92868
TidalHealth Peninsula Regional, Inc
Salisbury, Maryland, 21801
University of Utah Health
Salt Lake City, Utah, 84108
California Pacific Medical Center - Van Ness Campus
San Francisco, California, 94109
Richmond University Medical Center
Staten Island, New York, 10310
University of Toledo Medical Center
Toledo, Ohio, 43614

Other trials in United States

About this study

Official title: A Phase 2 Trial Evaluating Sargramostim in Patients With COVID-19 Associated Acute Hypoxemia

Read the 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.

Conditions: COVID-19, SARS-CoV-2
Being tested: Sargramostim, Standard of care
Keywords: COVID-19, sargramostim, Leukine, rhu-GM-CSF, acute hypoxemia, iLeukPulm, SARS-CoV-2
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SargramostimDrug
Also called Leukine, GM-CSF
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.
Standard of careDrug
Standard of care for COVID-19

Study groups in NCT04411680
Study group	Role	What they receive
Sargramostim Arm	Experimental	Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Receives: Drug: Sargramostim; Drug: Standard of care
Control Arm	Active comparator	Standard of care for COVID-19 Receives: Drug: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1-6 days
Number of Patients Who Have Been Intubated by Day 14
Measured: 1-14 days

Secondary outcomes (11)

Change in Ordinal Scale
The ordinal scale was used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.
Measured: 1-28 days
All Cause 28-day Mortality
Measured: 1-28 days
Number of Patients With Treatment-related Adverse Events
Number of patients with side effects related to treatment with sargramostim. Patients on the control arm did not receive sargramostim.
Measured: 1-58 days
Survival Time of Patients
Measured: Day 1-90
Causes of Death
Measured: Day 1-90
Change From Baseline in P/F Ratio
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.
Measured: From Day 1 up to Day 6
Number of Participants Wtih Nosocomial Infections
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.
Measured: Day 1-90
Number of Patients Requiring Invasive Mechanical Ventilation
The is the number of patients that needed to be placed on a ventilator.
Measured: Day 1-90
Duration of Invasive, Non-invasive and Supplemental Oxygen
This endpoint includes duration of any/all types of respiratory support
Measured: Day 1-90
Duration of Hospitalization
Measured: Day 1-90
Time to Normalization of White Blood Cells and Lymphocytes
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.
Measured: Day 1-90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 202019 May 2021

First posted2 Jun 2020
Study start18 Aug 2020
Primary completion2 Mar 2021
Study completion19 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04411680
Sponsor's protocol ID: PTX-001-002
Acronym: iLeukPulm
Status last verified: Aug 2023
First submitted: 29 May 2020
Last updated: 23 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36458916

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Trial Evaluating Sargramostim in Patients With COVID-19 Associated Acute Hypoxemia
ClinicalTrials.gov ID: NCT04411680
Acronym / sponsor ID: iLeukPulm / PTX-001-002
Conditions: COVID-19, SARS-CoV-2
Keywords: COVID-19, sargramostim, Leukine, rhu-GM-CSF, acute hypoxemia, iLeukPulm, SARS-CoV-2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Partner Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: United States Department of Defense
Study start: 18 Aug 2020 (actual)
Primary completion: 2 Mar 2021 (actual)
Study completion: 19 May 2021 (actual)
First posted: 2 Jun 2020 (actual)
Results: Posted 18 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Sargramostim Arm	Experimental	Drug: Sargramostim, Drug: Standard of careDay 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19
Control Arm	Active comparator	Drug: Standard of careStandard of care for COVID-19

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SargramostimAlso: Leukine, GM-CSFSargramostim 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.	Drug	Sargramostim Arm
Standard of careStandard of care for COVID-19	Drug	Control Arm, Sargramostim Arm

Primary outcome

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.
Number of Patients Who Have Been Intubated by Day 14
Time frame: 1-14 days

11 secondary outcomes

Change in Ordinal Scale
Time frame: 1-28 days
All Cause 28-day Mortality
Time frame: 1-28 days
Number of Patients With Treatment-related Adverse Events
Time frame: 1-58 days
Survival Time of Patients
Time frame: Day 1-90
Causes of Death
Time frame: Day 1-90
Change From Baseline in P/F Ratio
Time frame: From Day 1 up to Day 6
Number of Participants Wtih Nosocomial Infections
Time frame: Day 1-90
Number of Patients Requiring Invasive Mechanical Ventilation
Time frame: Day 1-90
Duration of Invasive, Non-invasive and Supplemental Oxygen
Time frame: Day 1-90
Duration of Hospitalization
Time frame: Day 1-90
Time to Normalization of White Blood Cells and Lymphocytes
Time frame: Day 1-90

Results and safety

Results posted to the registry on 18 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sargramostim Arm	78	49
Control Arm	44	36

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

Time frame: 1-6 days. Least squares mean (Standard Error). Unit: millimeters of mercury (mmHg)

Measure	Sargramostim Arm n = 63	Control Arm n = 33
Value	-102.3 (19.44)	-30.5 (26.88)

Population analysed: Patients analyzed if they had both a baseline and at least 1 post-baseline measurement.

Primary outcome: Number of Patients Who Have Been Intubated by Day 14

Time frame: 1-14 days. Count of participants. Unit: Participants

Measure	Sargramostim Arm n = 78	Control Arm n = 44
Value	9	7

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sargramostim Arm	15 of 78 (19.2%)	47 of 78 (60.3%)	11 of 78
Control Arm	14 of 44 (31.8%)	30 of 44 (68.2%)	8 of 44

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36458916Paine 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Information study director

Partner Therapeutics, Inc.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sargramostim in people with COVID-19 and SARS-CoV-2, run by Partner Therapeutics, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6 (time frame: 1-6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04411680, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.