Sargramostim in patients with acute hypoxic respiratory failure due to COVID-19

Phase 1

• Conditions: Acute hypoxic respiratory failure of COVID-19 patients; MedDRA version: 21.1Level: LLTClassification code 10074615Term: Hypoxic respiratory failureSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001254-22-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified