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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
CTRI/2020/11/029438 |
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Date of registration:
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27-11-2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Reinfection with SARS-COV-2 and associated factors
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Scientific title:
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Risk of COVID-19 re-infection and its predictors |
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Date of first enrolment:
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04-01-2021 |
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Target sample size:
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600 |
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Recruitment status: |
Closed to Recruitment of Participants |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49809 |
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Study type:
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Observational |
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Study design:
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Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Jacob John
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Address:
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Department of Community Health Christian Medical College
632002
Vellore, TAMIL NADU
India |
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Telephone:
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9442631628 |
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Email:
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jebu@cmcvellore.ac.in |
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Affiliation:
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Christian Medical College Vellore |
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Name:
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Jacob John
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Address:
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Department of Community Health Christian Medical College
632002
Vellore, TAMIL NADU
India |
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Telephone:
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9442631628 |
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Email:
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jebu@cmcvellore.ac.in |
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Affiliation:
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Christian Medical College Vellore |
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Key inclusion & exclusion criteria
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Inclusion criteria: Residents of the study area
Exclusion criteria: Acute febrile illness compatible with COVID19 at recruitment
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
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Primary Outcome(s)
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PCR confirmed SARS-COV-2 infectionTimepoint: 104 weekly samples for asymptomatic infection and adhoc samples when presenting with clinical illness compatible with COVID-19
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Secondary Outcome(s)
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SARS-COV-2 specific T Cell responsesTimepoint: Baseline, At diagnosis of covid-19 (D0), 2 weeks, 4 weeks, 3 months, 6 months, 12 months following diagnosis
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Memory B Cell AssaysTimepoint: Baseline, At diagnosis of COVID-19 (D0), 2 weeks, 4 weeks, 3 months, 6 months and 12 months following diagnosis
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cross-reactive T cells to non-SARS-CoV-2 human Coronaviruses (hCoV)Timepoint: Baseline at recruitment
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Source(s) of Monetary Support
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Bill and Melinda Gates Foundation
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Ethics review
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Status: Approved
Approval date: 25/11/2020
Contact:
Christian Medical College Vellore Institutional Review Board
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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