This is a Phase 3, open-label, multi-center, interventional safety study of REM therapy in participants 12 years of age or older with COVID-19, pneumonia and oxygen supplementation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
Remdesivir-HU 100 mg concentrate for solution for infusion
Department of Pulmonology Semmelweis University
Budapest, Hungary
National Korányi Institute for Pulmonology
Budapest, Hungary
North - Central Buda Center New St. János Hospital
Budapest, Hungary
Institute of Infectology, University of Debrecen
Debrecen, Hungary
To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA)
The primary endpoint of the study is the proportion of patients with at least one treatment-emergent AESI (hypersensitivity including infusion-related reaction, anaphylactic reaction, acute respiratory failure, hypotension, hepatic toxicity and nephrotoxicity).
Time frame: 30 days
The proportion of patients with at least 1 treatment-emergent adverse event
Secondary safety endpoint
Time frame: 30 days
Proportion of patients with treatment-emergent clinical
Secondary safety endpoint laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR)
Time frame: 30 days
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1st Department of Medicine, University of Pécs
Pécs, Hungary
Department of Internal Medicine University of Szeged
Szeged, Hungary
First Department of Internal Medicine, University of Szeged
Szeged, Hungary