Assess the Seroconversion Status of Health Care Workers Suspected or Confirmed Cases of COVID-19 Patients
A Prospective, Longitudinal, Observational Study to Assess the Seroconversion Status of Front Line Health Care Workers and Comparison With the Suspected or Confirmed Cases of COVID-19 Patients at Max Health Care (Project D)
1 other identifier
observational
1,000
1 country
1
Brief Summary
A large number of Health Care Workers (HCWs) would be potentially getting exposed to COVID19. Some of them would be asymptomatic or may get subclinical symptoms. Our HCW would have higher exposure and possibly higher seroconversion either symptomatic or with clinical symptoms than the general population. This study is aimed to understand the rate of seroconversion states at different stages of exposure. It is crucial to collect baseline immune status and the early immunological changes that might occur in asymptomatic or symptomatic health care workers and to compare that with the suspected or confirmed cases by following them for six weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2020
CompletedFirst Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedJuly 22, 2020
July 1, 2020
1.2 years
April 29, 2020
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of antibodies
Samples will be assessed for the presence of IgG and IgM
4-8 weeks
Study Arms (3)
Healthcare workers
The healthcare workers who are being tested for COVID-19 would be included in this group
OPD patients
Individuals outside from the hospital who are coming for the COVID-19 testing will be included in this group
IPD COVID-19 cases
Admitted positive cases of COVID-19 in the hospital will be included in this group
Eligibility Criteria
All employees of Max Hospital, Saket and Smart, New Delhi, who are coming to the hospital, working in the COVID ward or the nearby wards, and who would agree to participate will be recruited in this study including those who are being tested in suspicion of COVID-19. Samples and data of the COVID positive patients admitted in the hospital will also be collected. OPD patients coming to the hospital for COVID-19 testing will be one of the study subsets.
You may qualify if:
- Healthcare workers of Max Hospital, irrespective of age and gender OR
- COVID-19 positive patients admitted in the hospital OR
- Out-patients getting tested for COVID-19
You may not qualify if:
- Refusal to give informed consent, or contraindication to venipuncture.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Max Super Speciality Hospital, A Unit of Devki Devi Foundation
New Delhi, National Capital Territory of Delhi, 110017, India
Biospecimen
Serum and plasma samples are being stored at -70C
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sujeet Jha, MRCP (U.K)
Max Healthcare Institute Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
April 30, 2020
Study Start
April 22, 2020
Primary Completion
June 30, 2021
Study Completion
July 30, 2021
Last Updated
July 22, 2020
Record last verified: 2020-07