Covid19, End Stage Renal Failure on Dialysis
Conditions
Keywords
Remdesivir safety, COVID-19, Hemodialysis
Brief summary
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.
Interventions
DRUGRemdesivir
Remdesivir treatment
Sponsors
Semmelweis University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients at least 18 ys. of age * Ability to understand and sign informed consent form * End stage kidney disease of any cause, requiring hemodialysis * COVID-19 disease (with at least one positive SARS-CoV-2 RT-PCR or COVID-19 antigene quick test) * Radiologic evidence for pneumonia * Need for oxygen supplemental oxygen
Exclusion criteria
* Hemodynamically unstable patients (systolic blood pressure \<90Hgmm; heart rate\>120/min) * Significant liver enzyme elevation at screening (ASAT or ALAT \>2.5×ULN) * QTc \> 470 msec at baseline ECG (Bazett formule) * Need for mechanical ventilation or intensive care unit admission * Limited life expectancy (\<3 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event frequency | 14 days after completion of treatment | Number of adverse events occuring through the observational period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant ALAT elevation | continuously, 14 days after completion of treatment | Number of patients with significant (\>2× ULN or \>5× baseline) serum alanin aminotransferase elevation |
| Significant ALP elevation | continuously, 14 days after completion of treatment | Number of patients with significant (\>2× ULN or \>5× baseline) serum alkaline phosphatase elevation |
| Significant seBi elevation | continuously, 14 days after completion of treatment | Number of patients with significant (\>2× ULN or \>5× baseline) serum total bilirubin elevation |
| Significant ASAT elevation | continuously, 14 days after completion of treatment | Number of patients with significant (\>2× ULN or \>5× baseline) serum aspartate aminotransferase elevation |
| QTc prolongation | continuously, 14 days after completion of treatment | Change in corrected QTc interval measured on 12-lead ECG, corrected by Bazett's formule |
| Arrhythmia occurence | continuously, 14 days after completion of treatment | Number of patients with clinically significant (judged by investigator) ECG abnormalities |
| Frequency of suspected drug-induced injury | continuously, 14 days after completion of treatment | Number of patients with drug induced liver injury |
Countries
Hungary
Outcome results
None listed