NCT05069532

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

October 1, 2021

Last Update Submit

October 5, 2021

Conditions

COVID-19 Infection in Hemodialysis Patients

Outcome Measures

Primary Outcomes (1)

  • Incidence of COVID-19 infection in hemodialysis patients.

    radiological and laboratory findings on MSCT chest \& PCR respectively.

    1 year

Interventions

MSCT chestRADIATION

CORAD 4-5 MSCT chest

PCRDIAGNOSTIC_TEST

PCR positive for COVID-19

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • ALL Patients diagnosed COVID-19 other than hemodialysis patients.
  • Hemodialysis patients with chest infection other than COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 32467113BACKGROUND

  • Tortonese 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.

    PMID: 32838082BACKGROUND

  • Wu 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.

    PMID: 32444393BACKGROUND

  • Rombola 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.

    PMID: 32207068BACKGROUND

  • Xiong 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.

    PMID: 32385130BACKGROUND

  • Corbett 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.

    PMID: 32561681BACKGROUND

Central Study Contacts

Ahmad Bahieldeen Ahmad, MD

CONTACT

01009820300Ahmed-bahei@med.aun.edu.eg

Ashraf Anwar Elshazly, MD

CONTACT

01069176881

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 6, 2021

Study Start

October 1, 2021

Primary Completion

September 30, 2022

Study Completion

March 31, 2023

Last Updated

October 6, 2021

Record last verified: 2021-10