Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries
EVOLVE
1 other identifier
observational
550
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedStudy Start
First participant enrolled
June 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2024
CompletedJune 29, 2025
June 1, 2025
2 years
March 30, 2022
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Demographics
To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis
12 month
clinical characteristics
To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis
12 month
baseline and repeat administration
To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection
12 month
Secondary Outcomes (5)
Incidence of SARS-CoV-2 infection
12 Month
Incidence of all-cause hospitalization and mortality
12 Month
COVID-19 risk behavior at time of AZD7442
12 Month
Describe health-related quality of life
12 Month
describe COVID-19-related healthcare resource utilization
12 Month
Other Outcomes (4)
Describe the demographic and clinical characteristics
12 Month
Describe the incidence of long COVID syndrome
12 Month
Describe all-cause HCRU
12 Month
- +1 more other outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Abu Dhabi, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2022
First Posted
April 7, 2022
Study Start
June 23, 2022
Primary Completion
June 27, 2024
Study Completion
June 27, 2024
Last Updated
June 29, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Url Preview for AstraZeneca Clinical Trials Website AstraZeneca Clinical Trials Website This web site provides clinical trial data, results and other information regarding clinical trials astrazenecagrouptrials.pharmacm.com
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.