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

NCT ID: NCT04626076

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6808 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2022-06-15

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.

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

Conditions

SARS-CoV Infection; Covid19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Aga Khan University

Pakistan

Comparative Observational Cohort Study

Intervention Type: OTHER

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)

African Medical and Research Foundation- Uganda

Uganda

Comparative Observational Cohort Study

Intervention Type: OTHER

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)

African Medical and Research Foundation- Kenya

Kenya

Comparative Observational Cohort Study

Intervention Type: OTHER

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)

African Medical and Research Foundation- Zambia

Zambia

Comparative Observational Cohort Study

Intervention Type: OTHER

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)

African Medical and Research Foundation- Senegal

Senegal

Comparative Observational Cohort Study

Intervention Type: OTHER

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)

54Gene

Nigeria

Comparative Observational Cohort Study

Intervention Type: OTHER

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)

African Institute of Biomedical Science & Technology

Zimbabwe

Comparative Observational Cohort Study

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Parexel

INDUSTRY

Sponsor Role: collaborator

Certara

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Casciano, Masters

Role: PRINCIPAL_INVESTIGATOR

Certara

Craig Rayner, PharmD

Role: PRINCIPAL_INVESTIGATOR

Certara

Locations

Aga Khan University

Karachi, , Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CER-HCW-001

Identifier Type: -

Identifier Source: org_study_id