Clinical trial NCT04626076: International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
Official title: International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Covid19
Keywords: SARS-CoV-2 infection
SARS-CoV-2
COVID-19
Healthcare Workers
Lead sponsor: Certara
Sponsor class: INDUSTRY
Collaborators: name: Bill and Melinda Gates Foundation
name: Parexel
First posted: 2020-11-12
Enrollment: 6808
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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.

Primary outcomes:
measure: Occurrence of SARS-CoV-2 infection among HCWs caring for COVID-19 patients, in terms of time, geography, healthcare setting, type of HCW.
timeFrame: 12 weeks
Secondary outcomes:
measure: Occurrence of SARS-CoV-2 uninfected HCWs
timeFrame: 12 weeks
measure: Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of activities
timeFrame: 12 weeks
measure: Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of activities
timeFrame: 12 weeks
measure: Occurrence of hospitalization due to COVID-19 illness with mild disease
timeFrame: 12 weeks
measure: Occurrence of hospitalization due to COVID-19 illness with severe disease
timeFrame: 12 weeks
measure: Occurrence of all-cause mortality
timeFrame: 12 weeks
measure: Type of prophylactic treatments by dose, frequency and duration, overall and by country/region/site
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: Certara
name: Roman Casciano, Masters
role: PRINCIPAL_INVESTIGATOR
affiliation: Certara
name: Craig Rayner, PharmD
role: PRINCIPAL_INVESTIGATOR
References: