SARS-CoV InfectionNCT04626076
International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
An observational study of SARS-CoV Infection and Covid19, run by Certara at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Covid19
- What is being tested?
- Comparative Observational Cohort Study
- How many people
- 6,808 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Aug 2020to 15 Jun 2022
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- SARS-CoV Infection, Covid19
- Being tested
- Comparative Observational Cohort Study
- Keywords
- SARS-CoV-2 infection, SARS-CoV-2, COVID-19, Healthcare Workers
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparative Observational Cohort StudyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Aga Khan University | Pakistan Receives: Other: Comparative Observational Cohort Study | |
| African Medical and Research Foundation- Uganda | Uganda Receives: Other: Comparative Observational Cohort Study | |
| African Medical and Research Foundation- Kenya | Kenya Receives: Other: Comparative Observational Cohort Study | |
| African Medical and Research Foundation- Zambia | Zambia Receives: Other: Comparative Observational Cohort Study | |
| African Medical and Research Foundation- Senegal | Senegal Receives: Other: Comparative Observational Cohort Study | |
| 54Gene | Nigeria Receives: Other: Comparative Observational Cohort Study | |
| African Institute of Biomedical Science & Technology | Zimbabwe Receives: Other: Comparative Observational Cohort Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
Occurrence of SARS-CoV-2 uninfected HCWs
Subjects reporting "No" clinical diagnosis of COVID-19 or positive test results.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Occurrence of all-cause mortality
Assess occurrence of all-cause mortality.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start3 Aug 2020
- Primary completion5 Aug 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,808 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Certara
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation, Parexel
- Responsible party
- Sponsor
- Investigators
- Roman Casciano, Masters, Principal investigator, CertaraCraig Rayner, PharmD, Principal investigator, Certara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626076
- Sponsor's protocol ID
- CER-HCW-001
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Providing survey response mapping, serology results, and technical report on an open access platform (Vivli)
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)
- ClinicalTrials.gov ID
- NCT04626076
- Acronym / sponsor ID
- CER-HCW-001
- Conditions
- SARS-CoV Infection, Covid19
- Keywords
- SARS-CoV-2 infection, SARS-CoV-2, COVID-19, Healthcare Workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,808 participants (actual)
- Lead sponsor
- CertaraIndustry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation, Parexel
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Aga Khan University | – | Other: Comparative Observational Cohort StudyPakistan |
| African Medical and Research Foundation- Uganda | – | Other: Comparative Observational Cohort StudyUganda |
| African Medical and Research Foundation- Kenya | – | Other: Comparative Observational Cohort StudyKenya |
| African Medical and Research Foundation- Zambia | – | Other: Comparative Observational Cohort StudyZambia |
| African Medical and Research Foundation- Senegal | – | Other: Comparative Observational Cohort StudySenegal |
| 54Gene | – | Other: Comparative Observational Cohort StudyNigeria |
| African Institute of Biomedical Science & Technology | – | Other: Comparative Observational Cohort StudyZimbabwe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparative Observational Cohort StudyThis 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) | Other | 54Gene, African Institute of Biomedical Science & Technology, African Medical and Research Foundation- Kenya, African Medical and Research Foundation- Senegal, African Medical and Research Foundation- Uganda, African Medical and Research Foundation- Zambia, Aga Khan University |
Primary outcome
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
7 secondary outcomes
Occurrence of SARS-CoV-2 uninfected HCWs
Time frame: 12 weeks
Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of activities
Time frame: 12 weeks
Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of activities
Time frame: 12 weeks
Occurrence of hospitalization due to COVID-19 illness with mild disease
Time frame: 12 weeks
Occurrence of hospitalization due to COVID-19 illness with severe disease
Time frame: 12 weeks
Occurrence of all-cause mortality
Time frame: 12 weeks
Type of prophylactic treatments by dose, frequency and duration, overall and by country/region/site
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Yes. Providing survey response mapping, serology results, and technical report on an open access platform (Vivli)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Casciano, Masters principal investigator
Certara
Craig Rayner, PharmD principal investigator
Certara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection and Covid19, run by Certara at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.