COVID-19 Infection in Hemodialysis PatientsNCT05069532
COVID-19 Infection in Hemodialysis Patients
An observational study of COVID-19 Infection in Hemodialysis Patients, run by Assiut University.
Trial summary
Dialysis patients have a higher risk of infectious complications including complications from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19. There have been several reports describing the effect of CO¬VID-19 in the dialysis population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 Infection in Hemodialysis Patients
- What is being tested?
- MSCT chest and PCR
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 31 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with COVID-19 infection either highly suspicious radiological findings (CORAD 4-5) or proved by PCR for COVID-19.
Who may be able to join
- All hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with COVID-19 infection either highly suspicious radiological findings (CORAD 4-5) or proved by PCR for COVID-19.
Who cannot join
- ALL Patients diagnosed COVID-19 other than hemodialysis patients.
- Hemodialysis patients with chest infection other than COVID-19.
Trial locations and contacts
No sites are listed yet.
Ashraf Anwar Elshazly, MD contact
About this study
Official title: Incidence of COVID-19 Infection in Hemodialysis Patients and Predictors of Disease Complications and Mortality in Assiut University Hospital Hemodialysis Unit: A Cross-Sectional Study
Dialysis patients have a higher risk of infectious complications including complications from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19. There have been several reports describing the effect of CO¬VID-19 in the dialysis population.
Read the detailed description
A report of hospitalized COVID-19 patients from Wuhan, China, showed that hemodialysis patients had worse outcomes compared to controls without kidney failure. In addition, the hemodialysis COVID-19 patients developed serious complications such as shock, acute respiratory distress syndrome (ARDS), arrhythmias, and acute cardiac injury at a higher rate. In a population of hospitalized dialysis patients in New York City, there was a 31% mortality rate and 75% of those who required mechanical ventilation died.
These complications are due to some of their underlying comorbidities and difficulties of keeping adequate social distancing as recommended by CDC guidelines.
We aim to identify all hemodialysis patients who will be admitted from October 1, 2021 to Septemper 30, 2022. Patients who tested positive for COVID-19 by a polymerase chain reaction (PCR) or highly suspected (CORAD 4-5) according to radiological finding, will be selected and followed until discharge from hospital to determine who will develop complications and who will need ventilatory support. Also, the rate of death will be monitored. Therefore, the current study is aiming to better understand the hemodialysis patients' characteristics profile that makes them susceptible for complications and death.
- Being tested
- MSCT chest, PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCT chestRadiation
CORAD 4-5 MSCT chest
PCRDiagnostic test
PCR positive for COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID-19 infection in hemodialysis patients.
radiological and laboratory findings on MSCT chest \& PCR respectively.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Infection in Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aboelfatouh Tantawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069532
- Sponsor's protocol ID
- AATHAD
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Valeri AM, Robbins-Juarez SY, Stevens JS, Ahn W, Rao MK, Radhakrishnan J, Gharavi AG, Mohan S, Husain SA. Presentation and Outcomes of Patients with ESKD and COVID-19. J Am Soc Nephrol. 2020 Jul;31(7):1409-1415. doi: 10.1681/ASN.2020040470. Epub 2020 May 28.
PubMed 32467113Tortonese S, Scriabine I, Anjou L, Loens C, Michon A, Benabdelhak M, Ouali S, Morin G, Laifi M, Dobosziewicz H, Guillet M, Dekeyser M, Luong Nguyen LB, Grunenwald A, Dang J, Desbuissons G, Becquemont L, Snanoudj R, Legendre C, Hebibi H, Lefevre E, Beaudreuil S, Zaidan M; AP-HP/Universities/Inserm COVID-19 research collaboration. COVID-19 in Patients on Maintenance Dialysis in the Paris Region. Kidney Int Rep. 2020 Sep;5(9):1535-1544. doi: 10.1016/j.ekir.2020.07.016. Epub 2020 Jul 18.
PubMed 32838082Wu J, Li J, Zhu G, Zhang Y, Bi Z, Yu Y, Huang B, Fu S, Tan Y, Sun J, Li X. Clinical Features of Maintenance Hemodialysis Patients with 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. Clin J Am Soc Nephrol. 2020 Aug 7;15(8):1139-1145. doi: 10.2215/CJN.04160320. Epub 2020 May 22.
PubMed 32444393Rombola G, Heidempergher M, Pedrini L, Farina M, Aucella F, Messa P, Brunori G. Practical indications for the prevention and management of SARS-CoV-2 in ambulatory dialysis patients: lessons from the first phase of the epidemics in Lombardy. J Nephrol. 2020 Apr;33(2):193-196. doi: 10.1007/s40620-020-00727-y.
PubMed 32207068Xiong F, Tang H, Liu L, Tu C, Tian JB, Lei CT, Liu J, Dong JW, Chen WL, Wang XH, Luo D, Shi M, Miao XP, Zhang C. Clinical Characteristics of and Medical Interventions for COVID-19 in Hemodialysis Patients in Wuhan, China. J Am Soc Nephrol. 2020 Jul;31(7):1387-1397. doi: 10.1681/ASN.2020030354. Epub 2020 May 8.
PubMed 32385130Corbett RW, Blakey S, Nitsch D, Loucaidou M, McLean A, Duncan N, Ashby DR; West London Renal and Transplant Centre. Epidemiology of COVID-19 in an Urban Dialysis Center. J Am Soc Nephrol. 2020 Aug;31(8):1815-1823. doi: 10.1681/ASN.2020040534. Epub 2020 Jun 19.
PubMed 32561681
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of COVID-19 Infection in Hemodialysis Patients and Predictors of Disease Complications and Mortality in Assiut University Hospital Hemodialysis Unit: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05069532
- Acronym / sponsor ID
- AATHAD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 Oct 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.
Dialysis patients have a higher risk of infectious complications including complications from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19. There have been several reports describing the effect of CO¬VID-19 in the dialysis population.
Detailed description
A report of hospitalized COVID-19 patients from Wuhan, China, showed that hemodialysis patients had worse outcomes compared to controls without kidney failure. In addition, the hemodialysis COVID-19 patients developed serious complications such as shock, acute respiratory distress syndrome (ARDS), arrhythmias, and acute cardiac injury at a higher rate. In a population of hospitalized dialysis patients in New York City, there was a 31% mortality rate and 75% of those who required mechanical ventilation died.
These complications are due to some of their underlying comorbidities and difficulties of keeping adequate social distancing as recommended by CDC guidelines.
We aim to identify all hemodialysis patients who will be admitted from October 1, 2021 to Septemper 30, 2022. Patients who tested positive for COVID-19 by a polymerase chain reaction (PCR) or highly suspected (CORAD 4-5) according to radiological finding, will be selected and followed until discharge from hospital to determine who will develop complications and who will need ventilatory support. Also, the rate of death will be monitored. Therefore, the current study is aiming to better understand the hemodialysis patients' characteristics profile that makes them susceptible for complications and death.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with COVID-19 infection either highly suspicious radiological findings (CORAD 4-5) or proved by PCR for COVID-19.
Key inclusion criteria (1 listed)
- All hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with COVID-19 infection either highly suspicious radiological findings (CORAD 4-5) or proved by PCR for COVID-19.
Key exclusion criteria (2 listed)
- ALL Patients diagnosed COVID-19 other than hemodialysis patients.
- Hemodialysis patients with chest infection other than COVID-19.
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 |
|---|---|---|
| MSCT chestCORAD 4-5 MSCT chest | Radiation | – |
| PCRPCR positive for COVID-19 | Diagnostic test | – |
Primary outcome
Incidence of COVID-19 infection in hemodialysis patients.
Time frame: 1 year
radiological and laboratory findings on MSCT chest \& PCR respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 32467113Valeri AM, Robbins-Juarez SY, Stevens JS, Ahn W, Rao MK, Radhakrishnan J, Gharavi AG, Mohan S, Husain SA. Presentation and Outcomes of Patients with ESKD and COVID-19. J Am Soc Nephrol. 2020 Jul;31(7):1409-1415. doi: 10.1681/ASN.2020040470. Epub 2020 May 28.
- Background: PubMed 32838082Tortonese S, Scriabine I, Anjou L, Loens C, Michon A, Benabdelhak M, Ouali S, Morin G, Laifi M, Dobosziewicz H, Guillet M, Dekeyser M, Luong Nguyen LB, Grunenwald A, Dang J, Desbuissons G, Becquemont L, Snanoudj R, Legendre C, Hebibi H, Lefevre E, Beaudreuil S, Zaidan M; AP-HP/Universities/Inserm COVID-19 research collaboration. COVID-19 in Patients on Maintenance Dialysis in the Paris Region. Kidney Int Rep. 2020 Sep;5(9):1535-1544. doi: 10.1016/j.ekir.2020.07.016. Epub 2020 Jul 18.
- Background: PubMed 32444393Wu J, Li J, Zhu G, Zhang Y, Bi Z, Yu Y, Huang B, Fu S, Tan Y, Sun J, Li X. Clinical Features of Maintenance Hemodialysis Patients with 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. Clin J Am Soc Nephrol. 2020 Aug 7;15(8):1139-1145. doi: 10.2215/CJN.04160320. Epub 2020 May 22.
- Background: PubMed 32207068Rombola G, Heidempergher M, Pedrini L, Farina M, Aucella F, Messa P, Brunori G. Practical indications for the prevention and management of SARS-CoV-2 in ambulatory dialysis patients: lessons from the first phase of the epidemics in Lombardy. J Nephrol. 2020 Apr;33(2):193-196. doi: 10.1007/s40620-020-00727-y.
- Background: PubMed 32385130Xiong F, Tang H, Liu L, Tu C, Tian JB, Lei CT, Liu J, Dong JW, Chen WL, Wang XH, Luo D, Shi M, Miao XP, Zhang C. Clinical Characteristics of and Medical Interventions for COVID-19 in Hemodialysis Patients in Wuhan, China. J Am Soc Nephrol. 2020 Jul;31(7):1387-1397. doi: 10.1681/ASN.2020030354. Epub 2020 May 8.
- Background: PubMed 32561681Corbett RW, Blakey S, Nitsch D, Loucaidou M, McLean A, Duncan N, Ashby DR; West London Renal and Transplant Centre. Epidemiology of COVID-19 in an Urban Dialysis Center. J Am Soc Nephrol. 2020 Aug;31(8):1815-1823. doi: 10.1681/ASN.2020040534. Epub 2020 Jun 19.
- Individual participant dataSharing planned: Undecided
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.
Ashraf Anwar Elshazly, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection in Hemodialysis Patients, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Bahieldeen Ahmad, MD (01009820300, Ahmed-bahei@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of COVID-19 infection in hemodialysis patients. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069532, which also lists 6 linked publications.
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 6 Oct 2021.