NCT04872751

Brief Summary

The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 27, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

April 29, 2021

Last Update Submit

May 4, 2021

Conditions

Immune Response Post Covid 19 Vaccination

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level

    Study the antibody synthesis induced by vaccination, among end stage renal failure patients, and the change in its level at 1 month, at 6 months and at 1 year after complete vaccination.

    up to one year

Secondary Outcomes (1)

  • Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination)

    one month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end-stage renal failure (ESRF) receiving hemodialysis

You may qualify if:

  • ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme
  • years old and above
  • consented to join the study

You may not qualify if:

  • patient who refused to be vaccinated
  • patient who deemed unsuitable for Covid vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

RECRUITING

Study Officials

  • LokeMeng Ong

    Penang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

XueFang Tan

CONTACT

6042225333xf821020@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

April 27, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)