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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; SARS-CoV Infection
• Intervention / Treatment: Other: 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
• Enrollment (Actual): 6808

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan, 74800
    • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

As per the WHO definition10, HCWs eligible for enrollment are limited, based on the high likelihood of being exposed to COVID-19 patients during patient care, to the following positions:

• Medical doctors*
• Clinical officers*
• Licensed physician assistant or nurse practitioner*
• Registered nurse (or equivalent)*
• Assistant nurse, nurse technician (or equivalent)*
• Phlebotomist
• Clinical pharmacist
• Clinical physical therapist
• Respiratory therapist

• Community healthcare worker

  *These should include the following primary specialties:

• Surgery (all sub-specialties)
• Internal medicine (general)
• Pulmonology/critical care
• Emergency medicine
• Geriatrics
• Cardiology
• Infectious disease
• Anesthesiology
• Pediatrics
• Obstetrics/Midwifery
• Other

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aga Khan University; Pakistan	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)
African Medical and Research Foundation- Uganda; Uganda	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)
African Medical and Research Foundation- Kenya; Kenya	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)
African Medical and Research Foundation- Zambia; Zambia	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)
African Medical and Research Foundation- Senegal; Senegal	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)
54Gene; Nigeria	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)
African Institute of Biomedical Science & Technology; Zimbabwe	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of SARS-CoV-2 infection among HCWs caring for COVID-19 patients, in terms of time, geography, healthcare setting, type of HCW.	Assess the association of potential prophylactic treatments with reduced risk of COVID-19 (or SARS-CoV-2 infection) in HCWs caring for COVID-19 patients	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of SARS-CoV-2 uninfected HCWs	Subjects reporting "No" clinical diagnosis of COVID-19 or positive test results.	12 weeks
Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of activities	Subjects reporting COVID-19 related symptoms, clinical diagnosis of COVID-19 or positive test results but reporting "No" limitation of activities due to their symptoms and no hospitalization.	12 weeks
Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of activities	Subjects reporting COVID-19 symptoms, clinical diagnosis of COVID-19 or positive test results and reporting "Yes" to having their usual activities limited being limited due to their symptoms, but no hospitalization.	12 weeks
Occurrence of hospitalization due to COVID-19 illness with mild disease	Subjects being hospitalised without being admitted to the ICU or without ventilation.	12 weeks
Occurrence of hospitalization due to COVID-19 illness with severe disease	Subjects being hospitalised with either admittance to the ICU and/or receiving ventilation.	12 weeks
Occurrence of all-cause mortality	Assess occurrence of all-cause mortality.	12 weeks
Type of prophylactic treatments by dose, frequency and duration, overall and by country/region/site	Assess the association between prophylactic treatments and the risk of SARS-CoV-2 infection in HCWs caring for COVID-19 patients.	12 weeks

Collaborators and Investigators

• Sponsor: Certara
• Collaborators: Bill and Melinda Gates Foundation; Parexel
• Investigators: Principal Investigator: Roman Casciano, Masters, Certara; Principal Investigator: Craig Rayner, PharmD, Certara

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): August 5, 2021
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; SARS-CoV-2 infection; Healthcare Workers
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: CER-HCW-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Providing survey response mapping, serology results, and technical report on an open access platform (Vivli)
• IPD Sharing Time Frame: Available on the Vivli - Center for Global Clinical Research platform
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No