Study of Sargramostim in Patients With COVID-19 (NCT04411680) | Clinical Trial Compass
CompletedPhase 2
Study of Sargramostim in Patients With COVID-19
United States123 participantsStarted 2020-08-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, inc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6
Timeframe: 1-6 days
2
Number of Patients Who Have Been Intubated by Day 14