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

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.

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.

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.

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.

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.

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