Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04326920
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04326920
Study Brief:
Protocol Section:
NCT04326920