COVID-19EVOLVENCT05315323
Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries
An observational study of COVID-19, run by AstraZeneca at 2 sites in United Arab Emirates.
Trial summary
Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 550 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 23 Jun 2022to 27 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants included in this this study are all individuals who have received a AZD7442 first ever dose for the prevention of SARS-CoV-2 infection. In most countries this will be primarily subjects aged 12+ years.
Who may be able to join
- Individuals receiving their first dose of AZD7442 for the prevention of SARS-CoV-2 infection within the 30 days prior to study enrolment.
- The ability or willingness to sign informed consent/assent forms
Who cannot join
- Patients currently participating in interventional clinical trials of SARS-CoV-2 vaccines, other SARS-CoV-2 prophylactic interventions, or COVID-19 treatments.
- Patients with an ongoing COVID-19 infection at the time of AZD7442 administration as judged by the study physician.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
Research Site
Abu Dhabi
Research Site
Dubai
About this study
Official title: Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting - A Multi-center Observational Prospective Study to Determine Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
Read the detailed description
Study on Clinical use of EVUSHELD (AZD7442) as pre-exposure prophylaxis in the Real-world Setting Observational Prospective Study to determine the utilization and Clinical Outcomes of EVUSHELD in GCC.
This will be a multi-country, multi-centre, single-arm, observational, prospective study using primary data collection to describe the demographic and clinical characteristics of patients who received the first dose of AZD7442 for the prevention of SARS-CoV-2 infection causing symptomatic COVID-19 illness. The study will be conducted in the hospital/centers that are authorized to administer AZD7442, agree to participate in the study, and wherein investigators have access to all medical records (electronic/paper) for individual patients. The physicians at the hospital/centers will make a decision to administer AZD7442 to patients according to the local regulations (including the prescribing information) and such a decision to use AZD7442 is independent of the study.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, AZD7442, EVUSHELD, Real-world Setting
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis
Measured: 12 month
clinical characteristics
To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis
Measured: 12 month
baseline and repeat administration
To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection
Measured: 12 month
Secondary outcomes (5)
Incidence of SARS-CoV-2 infection
To describe the incidence of SARS-CoV-2 infection (asymptomatic or symptomatic), medically attended COVID-19, and COVID-19 related hospitalization and death up to 12 months after administration of AZD7442 for prevention of SARS-CoV-2 infection
Measured: 12 Month
Incidence of all-cause hospitalization and mortality
To describe the incidence of all-cause hospitalization and mortality during the 12 months after administration of AZD7442 for prevention of SAR-CoV-2 infection
Measured: 12 Month
COVID-19 risk behavior at time of AZD7442
To describe COVID-19 risk behavior at the time of AZD7442 injection and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection
Measured: 12 Month
Describe health-related quality of life
To describe health-related quality of life (QoL) at the time of AZD7442 first injection and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection
Measured: 12 Month
describe COVID-19-related healthcare resource utilization
To describe COVID-19-related healthcare resource utilization during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start23 Jun 2022
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315323
- Sponsor's protocol ID
- D8851R00001
- Acronym
- EVOLVE
- Status last verified
- Jun 2025
- First submitted
- 30 Mar 2022
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ is accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting - A Multi-center Observational Prospective Study to Determine Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
- ClinicalTrials.gov ID
- NCT05315323
- Acronym / sponsor ID
- EVOLVE / D8851R00001
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, AZD7442, EVUSHELD, Real-world Setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 7 Apr 2022 (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.
Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
Detailed description
Study on Clinical use of EVUSHELD (AZD7442) as pre-exposure prophylaxis in the Real-world Setting Observational Prospective Study to determine the utilization and Clinical Outcomes of EVUSHELD in GCC.
This will be a multi-country, multi-centre, single-arm, observational, prospective study using primary data collection to describe the demographic and clinical characteristics of patients who received the first dose of AZD7442 for the prevention of SARS-CoV-2 infection causing symptomatic COVID-19 illness. The study will be conducted in the hospital/centers that are authorized to administer AZD7442, agree to participate in the study, and wherein investigators have access to all medical records (electronic/paper) for individual patients. The physicians at the hospital/centers will make a decision to administer AZD7442 to patients according to the local regulations (including the prescribing information) and such a decision to use AZD7442 is independent of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants included in this this study are all individuals who have received a AZD7442 first ever dose for the prevention of SARS-CoV-2 infection. In most countries this will be primarily subjects aged 12+ years.
Key inclusion criteria (2 listed)
- Individuals receiving their first dose of AZD7442 for the prevention of SARS-CoV-2 infection within the 30 days prior to study enrolment.
- The ability or willingness to sign informed consent/assent forms
Key exclusion criteria (2 listed)
- Patients currently participating in interventional clinical trials of SARS-CoV-2 vaccines, other SARS-CoV-2 prophylactic interventions, or COVID-19 treatments.
- Patients with an ongoing COVID-19 infection at the time of AZD7442 administration as judged by the study physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographics
Time frame: 12 month
To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis
clinical characteristics
Time frame: 12 month
To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis
baseline and repeat administration
Time frame: 12 month
To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection
5 secondary outcomes
Incidence of SARS-CoV-2 infection
Time frame: 12 Month
Incidence of all-cause hospitalization and mortality
Time frame: 12 Month
COVID-19 risk behavior at time of AZD7442
Time frame: 12 Month
Describe health-related quality of life
Time frame: 12 Month
describe COVID-19-related healthcare resource utilization
Time frame: 12 Month
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 29 Jun 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ is accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by AstraZeneca at 2 sites in United Arab Emirates.
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 2 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. 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?
Demographics (time frame: 12 month). The study lists 3 primary outcomes in all. 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 29 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.