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Clinical Trial Details

Trial ID: L1680
Source ID: NCT04854837
Associated Drug: Remdesivir
Title: Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
Acronym: REM-HD
Status: COMPLETED
Study Results: NO
Results:
Conditions: Covid19|End Stage Renal Failure on Dialysis
Interventions: DRUG: Remdesivir
Outcome Measures: Primary: Adverse event frequency, Number of adverse events occuring through the observational period, 14 days after completion of treatment | Secondary: Significant ASAT elevation, Number of patients with significant (\>2× ULN or \>5× baseline) serum aspartate aminotransferase elevation, continuously, 14 days after completion of treatment|Significant ALAT elevation, Number of patients with significant (\>2× ULN or \>5× baseline) serum alanin aminotransferase elevation, continuously, 14 days after completion of treatment|Significant ALP elevation, Number of patients with significant (\>2× ULN or \>5× baseline) serum alkaline phosphatase elevation, continuously, 14 days after completion of treatment|Significant seBi elevation, Number of patients with significant (\>2× ULN or \>5× baseline) serum total bilirubin elevation, continuously, 14 days after completion of treatment|Frequency of suspected drug-induced injury, Number of patients with drug induced liver injury, continuously, 14 days after completion of treatment|QTc prolongation, Change in corrected QTc interval measured on 12-lead ECG, corrected by Bazett's formule, continuously, 14 days after completion of treatment|Arrhythmia occurence, Number of patients with clinically significant (judged by investigator) ECG abnormalities, continuously, 14 days after completion of treatment
Sponsor/Collaborators: Sponsor: Semmelweis University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 45
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2021-04-12
Completion Date: 2022-09-30
Results First Posted:
Last Update Posted: 2022-11-09
Locations: Semmelweis University - Department of Internal Medicine and Oncology, Budapest, 1083, Hungary
URL: https://clinicaltrials.gov/show/NCT04854837