Phase 2
Completed N=122
Study of Sargramostim in Patients With COVID-19
Source: ClinicalTrials.gov NCT04411680 ↗Enrolled (actual)
122
Serious AEs
23.8%
Results posted
Feb 2022
Primary outcomePrimary: Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6 — -102.3; -30.5 millimeters of mercury (mmHg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6 |
-102.3; -30.5 | — |
| PRIMARY Number of Patients Who Have Been Intubated by Day 14 |
9; 7 | — |
| SECONDARY Change in Ordinal Scale |
-2.6; -2.5 | — |
| SECONDARY All Cause 28-day Mortality |
9; 6 | — |
| SECONDARY Number of Patients With Treatment-related Adverse Events |
5; 0 | — |
| SECONDARY Survival Time of Patients |
76.0; 72.6 | — |
| SECONDARY Causes of Death |
4; 2; 6; 3; 1; 2 | — |
| SECONDARY Change From Baseline in P/F Ratio |
65.70; 47.24 | — |
| SECONDARY Number of Participants Wtih Nosocomial Infections |
0; 0 | — |
| SECONDARY Number of Patients Requiring Invasive Mechanical Ventilation |
12; 9 | — |
| SECONDARY Duration of Invasive, Non-invasive and Supplemental Oxygen |
37.9; 32.8 | — |
| SECONDARY Duration of Hospitalization |
12.1; 11.8 | — |
| SECONDARY Time to Normalization of White Blood Cells and Lymphocytes |
NA; NA | — |
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
Data sourced from ClinicalTrials.gov (NCT04411680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.