Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Completed

• Conditions: Covid19; End Stage Renal Failure on Dialysis
• Interventions: Drug: Remdesivir

• Registration Number: NCT04854837
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-22
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysed patients received remdesivir	Remdesivir	Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously

Primary Outcome Measures

Name	Time	Method
Adverse event frequency	14 days after completion of treatment	Number of adverse events occuring through the observational period

Secondary Outcome Measures

Name	Time	Method
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 ASAT elevation	continuously, 14 days after completion of treatment	Number of patients with significant (\>2× ULN or \>5× baseline) serum aspartate 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
Frequency of suspected drug-induced injury	continuously, 14 days after completion of treatment	Number of patients with drug induced liver injury
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

Trial Locations

Locations (1)

Semmelweis University - Department of Internal Medicine and Oncology; 🇭🇺 Budapest, Hungary