Status:
COMPLETED
Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
Lead Sponsor:
Semmelweis University
Conditions:
Covid19
End Stage Renal Failure on Dialysis
Eligibility:
All Genders
18+ years
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 pate...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04854837
Start Date
April 12 2021
End Date
September 30 2022
Last Update
November 9 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Semmelweis University - Department of Internal Medicine and Oncology
Budapest, Hungary, 1083