International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
1 other identifier
observational
6,808
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2020
CompletedFirst Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2022
CompletedApril 4, 2023
March 1, 2023
1 year
November 10, 2020
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Occurrence of SARS-CoV-2 uninfected HCWs
12 weeks
Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of activities
12 weeks
Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of activities
12 weeks
Occurrence of hospitalization due to COVID-19 illness with mild disease
12 weeks
Occurrence of hospitalization due to COVID-19 illness with severe disease
12 weeks
- +2 more secondary outcomes
Study Arms (7)
Aga Khan University
Pakistan
African Medical and Research Foundation- Uganda
Uganda
African Medical and Research Foundation- Kenya
Kenya
African Medical and Research Foundation- Zambia
Zambia
African Medical and Research Foundation- Senegal
Senegal
54Gene
Nigeria
African Institute of Biomedical Science & Technology
Zimbabwe
Interventions
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)
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Certaralead
- Bill and Melinda Gates Foundationcollaborator
- Parexelcollaborator
Study Sites (1)
Aga Khan University
Karachi, 74800, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Casciano, Masters
Certara
- PRINCIPAL INVESTIGATOR
Craig Rayner, PharmD
Certara
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2020
First Posted
November 12, 2020
Study Start
August 3, 2020
Primary Completion
August 5, 2021
Study Completion
June 15, 2022
Last Updated
April 4, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Available on the Vivli - Center for Global Clinical Research platform
- Access Criteria
- Open access
Providing survey response mapping, serology results, and technical report on an open access platform (Vivli)