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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626076
• Other study ID #: CER-HCW-001
• Status: Completed
• Start date: August 3, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: March 2023
• Source: Certara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6808
• Est. completion date: June 15, 2022
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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)

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (3)

Lead Sponsor	Collaborator
Certara	Bill and Melinda Gates Foundation, Parexel

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of SARS-CoV-2 uninfected HCWs	Subjects reporting "No" clinical diagnosis of COVID-19 or positive test results.	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Occurrence of all-cause mortality	Assess occurrence of all-cause mortality.	12 weeks
Secondary	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