The FDA approved the antiviral drug remdesivir for use in adults for the treatment of COVID-19 requiring hospitalization. There are only limited data about the safety of the drug in hemodialysed patents. Chronic kidney disease is a risk factor in COVID-19 for developing severe disease. The aim of our investigation is to observe the safety of remdesivir among hemodialysed patients requiring hospitalization for COVID-19. We are going to compare two group's data: 1. Hemodialysed COVID-19 patients requiring hospitalization because of pneumonia and need of oxygen supplementation, and admitted after 12/Apr/2021 - these patients received remdesivir. 2. Hemodialysed COVID-19 patients requiring hospitalization because of pneumonia and need of oxygen supplementation, and admitted before 12/Apr/2021 - these patients did not receive remdesivir.
Study Type
OBSERVATIONAL
Enrollment
45
Remdesivir treatment
Semmelweis University - Department of Internal Medicine and Oncology
Budapest, Hungary
Adverse event frequency
Number of adverse events occuring through the observational period
Time frame: 14 days after completion of treatment
Significant ASAT elevation
Number of patients with significant (\>2× ULN or \>5× baseline) serum aspartate aminotransferase elevation
Time frame: continuously, 14 days after completion of treatment
Significant ALAT elevation
Number of patients with significant (\>2× ULN or \>5× baseline) serum alanin aminotransferase elevation
Time frame: continuously, 14 days after completion of treatment
Significant ALP elevation
Number of patients with significant (\>2× ULN or \>5× baseline) serum alkaline phosphatase elevation
Time frame: continuously, 14 days after completion of treatment
Significant seBi elevation
Number of patients with significant (\>2× ULN or \>5× baseline) serum total bilirubin elevation
Time frame: continuously, 14 days after completion of treatment
Frequency of suspected drug-induced injury
Number of patients with drug induced liver injury
Time frame: continuously, 14 days after completion of treatment
QTc prolongation
Change in corrected QTc interval measured on 12-lead ECG, corrected by Bazett's formule
Time frame: continuously, 14 days after completion of treatment
Arrhythmia occurence
Number of patients with clinically significant (judged by investigator) ECG abnormalities
Time frame: continuously, 14 days after completion of treatment
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