REM-HD: Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Sponsor

Semmelweis University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04854837

Collaborator

(none)

Enrollment

Location

14.6

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 End Stage Renal Failure on Dialysis	Drug: Remdesivir

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

Actual Study Start Date :

Apr 12, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Hemodialysed patients received remdesivir Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously	Drug: Remdesivir Remdesivir treatment
Hemodialysed patients not received remdesivir Standard of care

Arm

Intervention/Treatment

Hemodialysed patients received remdesivir

Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously

Drug: Remdesivir

Remdesivir treatment

Hemodialysed patients not received remdesivir

Standard of care

Outcome Measures

Primary Outcome Measures

Adverse event frequency [14 days after completion of treatment]
Number of adverse events occuring through the observational period

Secondary Outcome Measures

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 ALAT elevation [continuously, 14 days after completion of treatment]
Number of patients with significant (>2× ULN or >5× baseline) serum alanin 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)