Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
NCT ID: NCT04854837
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
45 participants
OBSERVATIONAL
2021-04-12
2022-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hemodialysed patients received remdesivir
Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously
Remdesivir
Remdesivir treatment
Hemodialysed patients not received remdesivir
Standard of care
No interventions assigned to this group
Interventions
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Remdesivir
Remdesivir treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Istvan Takacs
Head of department
Locations
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Semmelweis University - Department of Internal Medicine and Oncology
Budapest, , Hungary
Countries
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Other Identifiers
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REM-HD
Identifier Type: -
Identifier Source: org_study_id
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