COVID-19 Infection in Hemodialysis Patients | NCT05069532

Studies
COVID-19 Infection in Hemodialysis Patients

NCT05069532

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 6, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19 Infection in Hemodialysis Patients

Interventions

MSCT chest
PCR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Estimated

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Mar 31, 2023Estimated

First Submitted Date

Oct 1, 2021

First Submission Date that Met QC Criteria

Oct 5, 2021

First Posted Date

Oct 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2021

Last Update Posted Date

Oct 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Aboelfatouh Tantawy, principal investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSCT chest	Radiation	CORAD 4-5 MSCT chest
PCR	Diagnostic Test	PCR positive for COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of COVID-19 infection in hemodialysis patients.	radiological and laboratory findings on MSCT chest & PCR respectively.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmad Bahieldeen Ahmad, MD	Contact	01009820300		Ahmed-bahei@med.aun.edu.eg
Ashraf Anwar Elshazly, MD	Contact	01069176881

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32467113	Background	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.
32838082	Background	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.