Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)
Condition: COVID-19
MeSH terms: COVID-19; Respiratory Insufficiency
Intervention: Sargramostim; Control
Intervention description: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration; Standard of care
Intervention MeSH terms: Sargramostim
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: GM-CSF; Acute Lung Injury; Hypoxia; Acute Respiratory Distress Syndrome; Corona virus; COVID-19; SARS (Severe Acute Respiratory Syndrome); Alveolar Macrophage; Acute Hypoxic respiratory failure

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.
    

Eligibility 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)