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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysed patients received remdesivir | Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously |
| |
| Hemodialysed patients not received remdesivir | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Remdesivir treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event frequency | Number of adverse events occuring through the observational period | 14 days after completion of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hemodialysed COVID-19 patients requiring hospitalization
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University - Department of Internal Medicine and Oncology | Budapest | 1083 | Hungary |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
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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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |