Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC) (NCT04326920) | Clinical Trial Compass
CompletedPhase 4
Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)
Belgium87 participantsStarted 2020-03-24
Plain-language 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 respiratory failure.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 met…
What they're measuring
1
Improvement in Oxygenation
Timeframe: on Day 6 or hospital discharge, whichever came first