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Completed

NCT Number: NCT04854837

Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections End Stage Renal Failure on Dialysis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University - Department of Internal Medicine and Oncology

Budapest, 1083, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Remdesivir

Drug

Remdesivir treatment

Primary outcomes

  1. Adverse event frequency

    Time frame: 14 days after completion of treatment

    Number of adverse events occuring through the observational period

Secondary outcomes

  1. Significant ASAT elevation

    Time frame: continuously, 14 days after completion of treatment

    Number of patients with significant (>2× ULN or >5× baseline) serum aspartate aminotransferase elevation

  2. Significant ALAT elevation

    Time frame: continuously, 14 days after completion of treatment

    Number of patients with significant (>2× ULN or >5× baseline) serum alanin aminotransferase elevation

  3. Significant ALP elevation

    Time frame: continuously, 14 days after completion of treatment

    Number of patients with significant (>2× ULN or >5× baseline) serum alkaline phosphatase elevation

  4. Significant seBi elevation

    Time frame: continuously, 14 days after completion of treatment

    Number of patients with significant (>2× ULN or >5× baseline) serum total bilirubin elevation

  5. Frequency of suspected drug-induced injury

    Time frame: continuously, 14 days after completion of treatment

    Number of patients with drug induced liver injury

  6. QTc prolongation

    Time frame: continuously, 14 days after completion of treatment

    Change in corrected QTc interval measured on 12-lead ECG, corrected by Bazett's formule

  7. Arrhythmia occurence

    Time frame: continuously, 14 days after completion of treatment

    Number of patients with clinically significant (judged by investigator) ECG abnormalities

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Acronym: REM-HD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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