Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)

• Status: Completed
• Trial end date: 2021-02-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborator: Flanders Institute of Biotechnology
• Treatments: Sargramostim

Criteria

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 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)