Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries
- Conditions
- COVID-19
- Registration Number
- NCT05315323
- Lead Sponsor
- AstraZeneca
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical characteristics 12 month To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis
baseline and repeat administration 12 month To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection
Demographics 12 month To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis
- Secondary Outcome Measures
Name Time Method COVID-19 risk behavior at time of AZD7442 12 Month 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
describe COVID-19-related healthcare resource utilization 12 Month To describe COVID-19-related healthcare resource utilization during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection
Incidence of SARS-CoV-2 infection 12 Month 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
Describe health-related quality of life 12 Month 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
Incidence of all-cause hospitalization and mortality 12 Month 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
Trial Locations
- Locations (1)
Research Site
🇦🇪Dubai, United Arab Emirates