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

Certara

Status: Completed

Conditions: SARS-CoV Infection; Covid19

Treatments: Other: Comparative Observational Cohort Study

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04626076

CER-HCW-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 6,808 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

6,808 participants in 7 patient groups

Aga Khan University

Description:

Pakistan

Treatment:

Other: Comparative Observational Cohort Study

African Medical and Research Foundation- Uganda

Description:

Uganda

Treatment:

Other: Comparative Observational Cohort Study

African Medical and Research Foundation- Kenya

Description:

Kenya

Treatment:

Other: Comparative Observational Cohort Study

African Medical and Research Foundation- Zambia

Description:

Zambia

Treatment:

Other: Comparative Observational Cohort Study

African Medical and Research Foundation- Senegal

Description:

Senegal

Treatment:

Other: Comparative Observational Cohort Study

54Gene

Description:

Nigeria

Treatment:

Other: Comparative Observational Cohort Study

African Institute of Biomedical Science & Technology

Description:

Zimbabwe

Treatment:

Other: Comparative Observational Cohort Study