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NCT04626076 | COMPLETED | SARS-CoV Infection


International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
Sponsor:

To fight

Brief Summary:

The International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global), is an international registry of approximately 10,000 healthcare workers in low- and middle-income countries experiencing increasing numbers of COVID-19 cases and commensurate increased exposure to the SARS-CoV-2 virus among their healthcare worker populations.

Condition or disease

SARS-CoV Infection

Covid19

Intervention/treatment

Comparative Observational Cohort Study

Detailed Description:

The registry will enrol HCWs who are experiencing or are expected to experience ongoing and recurrent close contact with confirmed or clinically diagnosed COVID-19 patients. Recruitment for the registry will aim to enrol a representative distribution of HCWs on the front lines of diagnosing and caring for COVID-19 patients in both hospitals and community settings, as well as a balanced sample of HCWs receiving the most commonly administered putatively prophylactic drug regimens. The registry will collect information on a weekly basis from HCWs across a 12-week period following their first known exposure to confirmed or clinically diagnosed COVID-19 patients prior to or within 30 days after enrollment. Data collection will include the drug regimens being taken by the HCWs, information about their level of exposure to COVID-19 patients, their personal health status, and other factors such as the use of PPE which would likely impact their risk of developing a SARS-CoV-2 infection. A standard pharmaco-epidemiological inferential analysis will be conducted treating the registry data as a cohort with dynamic exposure to both prophylactic treatment and to COVID-19 infected patients and adjusting for potential confounding. Crude and adjusted hazards ratios will be estimated for each of the prophylactic regimens of interest and any observed impact on the risk of infection among HCWs based on all statistical inferential models will be reported

Study Type : OBSERVATIONAL
Estimated Enrollment : 6808 participants
Official Title : International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
Actual Study Start Date : 2020-08-03
Estimated Primary Completion Date : 2021-08-05
Estimated Study Completion Date : 2022-06-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • Healthcare workers will be entered into this study only if they meet ALL the following criteria
    • * Healthcare workers aged ≥ 18 years.
    • * Healthcare workers must be exposed through ongoing and recurrent contact to a confirmed or clinically diagnosed COVID-19 patient prior to enrollment, or anticipated within 30 days after enrollment.
    • * Healthcare workers must consent to provide data for the registry and must be willing to be contacted/reminded about data entry at each follow-up time point.
    • * Healthcare workers must agree to provide a secondary contact for follow-up.
    Exclusion Criteria
    • * A confirmed SARS-CoV-2 infection or clinically diagnosed COVID-19 prior to the first known exposure to confirmed or clinically diagnosed COVID-19 patient (Index Date).
    • * Participation in a 'blinded' clinical trial, i.e. unaware of exact treatment received as part of the clinical trial.

International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)

Location Details

NCT04626076


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Pakistan,

Aga Khan University

Karachi, Pakistan, 74800

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