NCT05212675

Brief Summary

Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19. Also the potential variants according with worse outcomes remain to be fully elucidated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 24, 2022

Last Update Submit

January 26, 2022

Conditions

COVID-19

Keywords

Dialysis

Outcome Measures

Primary Outcomes (2)

  • Mortality

    discharged or dead

    From date of randomization until the date of first documented progression or date of death

  • ICU add

    admission to ICU or not

    From date of randomization until the date of first documented progression or date of death

Study Arms (2)

short daily dialysis

OTHER

7 days 2hours dialysis

Other: Short daily dialysis

conventional dialysis

NO INTERVENTION

3 times weekly 4hours dialysis

Interventions

Short daily dialysisOTHER

7 days 2hours dialysis

short daily dialysis

Eligibility Criteria

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

You may qualify if:

  • ESRD patients \>3months on hemodialysis admitted for COVID-19

You may not qualify if:

  • ESRD patients \<3 months on hemodialysis infected with COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nooshin Dalili

Tehran, Iran

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nooshin Dalili, MD

    SBMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2022

First Posted

January 28, 2022

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

August 30, 2021

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)