Clinical trial NCT04854837: Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
Official title: Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
End Stage Renal Failure on Dialysis
Keywords: Remdesivir safety
COVID-19
Hemodialysis
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hemodialysed COVID-19 patients requiring hospitalization

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Adverse event frequency
timeFrame: 14 days after completion of treatment
Secondary outcomes:
measure: Significant ASAT elevation
timeFrame: continuously, 14 days after completion of treatment
measure: Significant ALAT elevation
timeFrame: continuously, 14 days after completion of treatment
measure: Significant ALP elevation
timeFrame: continuously, 14 days after completion of treatment
measure: Significant seBi elevation
timeFrame: continuously, 14 days after completion of treatment
measure: Frequency of suspected drug-induced injury
timeFrame: continuously, 14 days after completion of treatment
measure: QTc prolongation
timeFrame: continuously, 14 days after completion of treatment
measure: Arrhythmia occurence
timeFrame: continuously, 14 days after completion of treatment
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University - Department of Internal Medicine and Oncology
Study officials:
References: