A prospective, randomized, open-label, interventional study to investigate the efficacy of sargramostim (Leukine®) in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. - SARPAC

niversity Hospital Ghent0 个研究点目标入组 80 人开始时间: 2020年3月24日最近更新: 2021年8月10日

适应症

试验速览

暂无简介。

•- 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

•- 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)

发起方

niversity Hospital Ghent