Covid19REM-HDNCT04854837
Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
An observational study of Covid19 and End Stage Renal Failure on Dialysis, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, End Stage Renal Failure on Dialysis
- What is being tested?
- Remdesivir
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteHungary
- Study dates
- 12 Apr 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysed COVID-19 patients requiring hospitalization
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University - Department of Internal Medicine and Oncology
Budapest, 1083
About this study
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.
Read more
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.
- Conditions
- Covid19, End Stage Renal Failure on Dialysis
- Being tested
- Remdesivir
- Keywords
- Remdesivir safety, COVID-19, Hemodialysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Remdesivir treatment
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysed patients received remdesivir | Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously Receives: Drug: Remdesivir | |
| Hemodialysed patients not received remdesivir | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event frequency
Number of adverse events occuring through the observational period
Measured: 14 days after completion of treatment
Secondary outcomes (7)
Significant ASAT elevation
Number of patients with significant (>2× ULN or >5× baseline) serum aspartate aminotransferase elevation
Measured: continuously, 14 days after completion of treatment
Significant ALAT elevation
Number of patients with significant (>2× ULN or >5× baseline) serum alanin aminotransferase elevation
Measured: continuously, 14 days after completion of treatment
Significant ALP elevation
Number of patients with significant (>2× ULN or >5× baseline) serum alkaline phosphatase elevation
Measured: continuously, 14 days after completion of treatment
Significant seBi elevation
Number of patients with significant (>2× ULN or >5× baseline) serum total bilirubin elevation
Measured: continuously, 14 days after completion of treatment
Frequency of suspected drug-induced injury
Number of patients with drug induced liver injury
Measured: continuously, 14 days after completion of treatment
QTc prolongation
Change in corrected QTc interval measured on 12-lead ECG, corrected by Bazett's formule
Measured: continuously, 14 days after completion of treatment
Arrhythmia occurence
Number of patients with clinically significant (judged by investigator) ECG abnormalities
Measured: continuously, 14 days after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start12 Apr 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Takacs, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854837
- Sponsor's protocol ID
- REM-HD
- Acronym
- REM-HD
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
- ClinicalTrials.gov ID
- NCT04854837
- Acronym / sponsor ID
- REM-HD / REM-HD
- Conditions
- Covid19, End Stage Renal Failure on Dialysis
- Keywords
- Remdesivir safety, COVID-19, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysed patients received remdesivir | – | Drug: RemdesivirRemdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously |
| Hemodialysed patients not received remdesivir | – | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysed COVID-19 patients requiring hospitalization
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemdesivirRemdesivir treatment | Drug | Hemodialysed patients received remdesivir |
Primary outcome
Adverse event frequency
Time frame: 14 days after completion of treatment
Number of adverse events occuring through the observational period
7 secondary outcomes
Significant ASAT elevation
Time frame: continuously, 14 days after completion of treatment
Significant ALAT elevation
Time frame: continuously, 14 days after completion of treatment
Significant ALP elevation
Time frame: continuously, 14 days after completion of treatment
Significant seBi elevation
Time frame: continuously, 14 days after completion of treatment
Frequency of suspected drug-induced injury
Time frame: continuously, 14 days after completion of treatment
QTc prolongation
Time frame: continuously, 14 days after completion of treatment
Arrhythmia occurence
Time frame: continuously, 14 days after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and End Stage Renal Failure on Dialysis, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event frequency (time frame: 14 days after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.