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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; End Stage Renal Failure on Dialysis
• Intervention / Treatment: Drug: Remdesivir

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis University - Department of Internal Medicine and Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hemodialysed COVID-19 patients requiring hospitalization

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Hemodialysis; Remdesivir safety
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; COVID-19; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Remdesivir
• Other Study ID Numbers: REM-HD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No