Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Study Overview
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Brief Summary
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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: Hemodialysed COVID-19 patients requiring hospitalization because of pneumonia and need of oxygen supplementation, and admitted after 12/Apr/2021 - these patients received remdesivir. 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.

Official Title
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Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Conditions
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Covid19, End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Drug: Remdesivir


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodialysed patients received remdesivir<br>Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously | Drug: Remdesivir<br>* Remdesivir treatment<br>|
| Hemodialysed patients not received remdesivir<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event frequency | Number of adverse events occuring through the observational period | 14 days after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Remdesivir safety, Hemodialysis