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NCT Number: NCT05315323

Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting 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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Abu Dhabi, United Arab Emirates

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Demographics

    Time frame: 12 month

    To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis

  2. clinical characteristics

    Time frame: 12 month

    To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis

  3. 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

Secondary outcomes

  1. Incidence of SARS-CoV-2 infection

    Time frame: 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

  2. Incidence of all-cause hospitalization and mortality

    Time frame: 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

  3. COVID-19 risk behavior at time of AZD7442

    Time frame: 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

  4. Describe health-related quality of life

    Time frame: 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

  5. describe COVID-19-related healthcare resource utilization

    Time frame: 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

Other outcomes

  1. Describe the demographic and clinical characteristics

    Time frame: 12 Month

    To describe the demographic and clinical characteristics of SARS-CoV-2 infection (asymptomatic or symptomatic), medically attended COVID-19, and COVID-19 related hospitalized cases occurring up to 12 months following AZD7442 first administration for prevention of SARS-CoV-2 infection in comparison to non-cases

  2. Describe the incidence of long COVID syndrome

    Time frame: 12 Month

    To describe the incidence of long COVID syndrome following AZD7442 administration for prevention of SARS-CoV-2 infection

  3. Describe all-cause HCRU

    Time frame: 12 Month

    To describe all-cause HCRU in the 12 months prior to and during the 12 months after AZD7442 first injection for prevention of SARS-CoV-2 infection

  4. Describe COVID-19-related work loss/school absenteeism

    Time frame: 12 Month

    To describe COVID-19-related work loss/school absenteeism at baseline (last 6 months) and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: EVOLVE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2022
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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