Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Covid19 Clinical Trial

— REM-HD  

Official title:

Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854837
• Other study ID #: REM-HD
• Status: Completed
• Start date: April 12, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19
• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

Intervention

Drug:
• Remdesivir
Remdesivir treatment

Locations

Country	Name	City	State
Hungary	Semmelweis University - Department of Internal Medicine and Oncology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event frequency	Number of adverse events occuring through the observational period	14 days after completion of treatment
Secondary	Significant ASAT elevation	Number of patients with significant (>2× ULN or >5× baseline) serum aspartate aminotransferase elevation	continuously, 14 days after completion of treatment
Secondary	Significant ALAT elevation	Number of patients with significant (>2× ULN or >5× baseline) serum alanin aminotransferase elevation	continuously, 14 days after completion of treatment
Secondary	Significant ALP elevation	Number of patients with significant (>2× ULN or >5× baseline) serum alkaline phosphatase elevation	continuously, 14 days after completion of treatment
Secondary	Significant seBi elevation	Number of patients with significant (>2× ULN or >5× baseline) serum total bilirubin elevation	continuously, 14 days after completion of treatment
Secondary	Frequency of suspected drug-induced injury	Number of patients with drug induced liver injury	continuously, 14 days after completion of treatment
Secondary	QTc prolongation	Change in corrected QTc interval measured on 12-lead ECG, corrected by Bazett's formule	continuously, 14 days after completion of treatment
Secondary	Arrhythmia occurence	Number of patients with clinically significant (judged by investigator) ECG abnormalities	continuously, 14 days after completion of treatment