Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis (NCT04854837) | Clinical Trial Compass
CompletedNot Applicable
Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
Hungary45 participantsStarted 2021-04-12
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.