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.
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
Other: Comparative Observational Cohort Study
This is a comparative observational cohort study; therefore, no preventive interventions, visits or laboratory tests are mandated. Dosing and duration of potential prophylactic treatment is at the discretion of the institution and/or healthcare provider, in accordance with regular local practice. However, serology testing for SARS-CoV-2 antibodies will be offered to the first 50% of participating HCWs per country, at enrollment and at the last follow-up (i.e. at Week 12)
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.
Aga Khan University
Karachi, Pakistan