ICMR ââ?¬â?? RUMC COVID-19 Sequelae Study among Health Care Workers

• Register: CTRI
• Last refreshed on: 17 October 2022
• Main ID: CTRI/2021/06/034255
• Date of registration: 15-06-2021
• Prospective Registration: Yes
• Primary sponsor: ICMR
• Public title: ICMR ââ?¬â?? RUMC COVID-19 Sequelae Study among Health Care Workers
• Scientific title: ICMR ââ?¬â?? RUMC COVID-19 Sequelae Study among Health Care Workers
• Date of first enrolment: 01-07-2021
• Target sample size: 557
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53972
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Shubham Atal
• Affiliation: Department of Pharmacology, AIIMS, Bhopal, M.P.

• Name: Dr Shubham Atal
• Affiliation: Department of Pharmacology, AIIMS, Bhopal, M.P.

Key inclusion & exclusion criteria

Inclusion criteria: All consenting HCWs with laboratory confirmation of COVID-19 infection including asymptomatic cases, working in ICMR RUMC institutions who have recovered (been declared ââ?¬Ë?dischargedââ?¬•) as per MoHFW guidelines 12 to 52 weeks ago.
Exclusion criteria: 1. Any serious co-morbid medical or mental health condition that would make the subject unable to participate in the study.



2. Pregnancy



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Primary Outcome(s)

1. Estimation of prevalence of persistent symptoms in recovered COVID-19 HCWs.



2. Estimation of the associated with the medical sequelae in recovered COVID-19 HCWs.Timepoint: In this study, data collection from HCWs who had recovered (ââ?¬Ë?dischargedââ?¬â?¢) from COVID-19 12 to 52 weeks ago.

Secondary Outcome(s)

1. Occurrence of medical sequelae following COVID-19 infection among the HCWs who have taken hydroxychloroquine prophylaxis versus HCWs who have not taken hydroxychloroquine prophylaxis.



2. Prevalence of vaccination hesitancy and factors associated with it.Timepoint: In this study, data collection from HCWs who had recovered (ââ?¬Ë?dischargedââ?¬â?¢) from COVID-19 12 to 52 weeks ago.

Secondary ID(s)

NIL

Source(s) of Monetary Support

Name: Indian Council of Medical Research Address: V. Ramalingaswami Bhawan, P.O. Box No- 4911 Ansari Nagar, New Delhi- 110029, India

Ethics review

Status: Approved
Approval date: 23/03/2021
Contact:

Institutional Ethics Committee, IGIMS, Patna

Status: Approved
Approval date: 05/05/2021
Contact:

St. Johns Medical College IERB, Bangalore

Status: Approved
Approval date: 12/05/2021
Contact:

Institutional Ethics Committee for Observational Studies, JIPMER

Status: Approved
Approval date: 21/05/2021
Contact:

Institutional Human Ethics Committee, AIIMS Bhopal AIIMS Bhopal

Status: Approved
Approval date: 18/06/2021
Contact:

Institutional Ethics Committee, Seth GS Medical college and KEM Hospital, Mumbai

Status: Approved
Approval date: 29/06/2021
Contact:

Institute Ethics Committee, CMC, Ludhiana

Status: Approved
Approval date: 25/08/2021
Contact:

Institutional Ethics Committee, VMMC, New Delhi

Status: Approved
Approval date: 03/09/2021
Contact:

Institutional Ethics Committee for Biomedical and Health Research, Medical College and SSG Hospital, Vadodara

Results

• Date Completed: 15/10/2021