COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04326920

Anja Delporte

anja.delporte@uzgent.be

2020-03-30

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

- 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)

2

University Hospital, Ghent

18

80

Belgium

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

87

Improvement in Oxygenation

None

Phase 4

[{"arm_notes": "", "treatment_id": 1147, "treatment_name": "Sargramostim", "treatment_type": "Csf", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]