Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

NCT04854837 | Completed

• 1 other identifier: REM-HD
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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:

1. 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. 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.

Conditions

Covid19; End Stage Renal Failure on Dialysis

Keywords

Remdesivir safety; COVID-19; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Adverse event frequency

  Number of adverse events occuring through the observational period

  14 days after completion of treatment

Secondary Outcomes (7)

• Significant ASAT elevation

  continuously, 14 days after completion of treatment

• Significant ALAT elevation

  continuously, 14 days after completion of treatment

• Significant ALP elevation

  continuously, 14 days after completion of treatment

• Significant seBi elevation

  continuously, 14 days after completion of treatment

• Frequency of suspected drug-induced injury

  continuously, 14 days after completion of treatment

Study Arms (2)

Hemodialysed patients received remdesivir

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

Drug: Remdesivir

Hemodialysed patients not received remdesivir

Standard of care

Interventions

Remdesivir DRUG

Remdesivir treatment

Hemodialysed patients received remdesivir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hemodialysed COVID-19 patients requiring hospitalization

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University - Department of Internal Medicine and Oncology

Budapest, 1083, Hungary

Location

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 22, 2021
• Study Start: April 12, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)