COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001254-22/BE

University Hospital Ghent - HIRUZ CTU

hiruz.ctu@uzgent.be

2020-03-24

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

- Recent (≤2weeks prior to randomization) confident diagnosis of COVID-19 confirmed by antigen detection and/or PCR, 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 350 - 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)

3

University Hospital Ghent

18

80

Belgium

Severe disease at enrollment

6: Severe disease at enrollment

80

To measure the effectiveness of sargramostim on restoring lung homeostasis, the primary endpoint of this intervention is measuring oxygenation after 5 DAYS of inhaled (and intravenous) treatment through assessment of pretreatment (day 0) and post-treatment (day 5) ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient, which can easily be performed in the setting of clinical observation of patients admitted to the COVID -19 ward or ICU COVID-19 unit. Preferentially, this measurement should be done in the upright position, while breathing room air for a minimum of 3 minutes.. If this is impossible due to need for supplemental oxygen, FiO2 and oxygen supplementation method should be recorded in patient record, so that A-a gradient can be normalized for age expected normal A-a gradient while on supplemental oxygen use. During the 5 day treatment period, we will perform daily measurements of oxygen saturation (pulse oximetry) in relation to FiO2, and the slope of alterations in this parameters could also be an indicator that our hypothesis is correct. If the patient leaves hospital prior to the day 6 analysis point, oxygenation at day of discharge will be used as value for measuring primary endpoint.

nan

Phase 4

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