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

Semmelweis University

Status

Completed

Conditions

End Stage Renal Failure on Dialysis

Covid19

Treatments

Drug: Remdesivir

Study type

Observational

Funder types

Other

Identifiers

NCT04854837

REM-HD

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)