Status:
COMPLETED
Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Flemish institute of biotechnology (VIB)
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic ...
Detailed Description
Leukine® is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF, sargramostim) and the only FDA approved GM-CSF. GMCSF, a pleiotropic cytokine, is an impo...
Eligibility Criteria
Inclusion
- Recent (≤2weeks prior to Randomization) confident diagnosis of COVID-19 confirmed by antigen detection and/or PCR (Polymerase Chain Reaction), and/or seroconversion or any other emerging and validated diagnostic test
- In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (\<24h) chest-CT scan (confirmed by a radiologist and pulmonary physician as probable COVID-19), a patient can be enrolled as probable COVID-19 infected. In all cases, this needs confirmation by later seroconversion.
- Presence of acute hypoxic respiratory failure defined as (either or both)
- saturation below 93% on minimal 2 l/min O2
- PaO2/FiO2 below 300
- Admitted to specialized COVID-19 ward
- Age 18-80
- Male or Female
- Willing to provide informed consent
Exclusion
- Patients with known history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product.
- mechanical ventilation before start of study
- patients with peripheral white blood cell count above 25.000 per microliter and/or active myeloid malignancy
- patients on high dose systemic steroids (\> 20 mg methylprednisolone or equivalent)
- patients on lithium carbonate therapy
- Patients enrolled in another investigational drug study
- Pregnant or breastfeeding females (all female subjects regardless of childbearing potential status must have negative pregnancy test at screening)
- Patients with serum ferritin \>2000 mcg/ml (which will exclude ongoing HLH)
Key Trial Info
Start Date :
March 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04326920
Start Date
March 24 2020
End Date
February 26 2021
Last Update
November 16 2022
Active Locations (4)
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1
AZ Sint Jan Brugge
Bruges, Belgium, 8000
2
University Hospital Ghent
Ghent, Belgium, 9000
3
UZ Brussel
Jette, Belgium, 1090
4
AZ Delta Roeselare
Roeselare, Belgium, 8800