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NCT Number: NCT04626076

International Registry of Healthcare Workers Exposed to COVID-19 Patients (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.

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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aga Khan University

Karachi, 74800, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comparative Observational Cohort Study

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)

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.

    Time frame: 12 weeks

    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

Secondary outcomes

  1. Occurrence of SARS-CoV-2 uninfected HCWs

    Time frame: 12 weeks

    Subjects reporting "No" clinical diagnosis of COVID-19 or positive test results.

  2. Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of activities

    Time frame: 12 weeks

    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.

  3. Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of activities

    Time frame: 12 weeks

    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.

  4. Occurrence of hospitalization due to COVID-19 illness with mild disease

    Time frame: 12 weeks

    Subjects being hospitalised without being admitted to the ICU or without ventilation.

  5. Occurrence of hospitalization due to COVID-19 illness with severe disease

    Time frame: 12 weeks

    Subjects being hospitalised with either admittance to the ICU and/or receiving ventilation.

  6. Occurrence of all-cause mortality

    Time frame: 12 weeks

    Assess occurrence of all-cause mortality.

  7. Type of prophylactic treatments by dose, frequency and duration, overall and by country/region/site

    Time frame: 12 weeks

    Assess the association between prophylactic treatments and the risk of SARS-CoV-2 infection in HCWs caring for COVID-19 patients.

Sponsors and collaborators

Lead sponsor

Certara

Industry

Collaborators

  • Bill and Melinda Gates Foundation
  • Parexel

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 12, 2020
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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