Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-23

Study Completion Date

2024-06-27

Brief Summary

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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

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Detailed Description

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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

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No