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

COVID-19 Clinical Trial

— EVOLVE  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05315323
• Other study ID #: D8851R00001
• Status: Active, not recruiting
• Start date: June 23, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United Arab Emirates	Research Site	Abu Dhabi
United Arab Emirates	Research Site	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Describe the demographic and clinical characteristics	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	12 Month
Other	Describe the incidence of long COVID syndrome	To describe the incidence of long COVID syndrome following AZD7442 administration for prevention of SARS-CoV-2 infection	12 Month
Other	Describe all-cause HCRU	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	12 Month
Other	Describe COVID-19-related work loss/school absenteeism	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	12 Month
Primary	Demographics	To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis	12 month
Primary	clinical characteristics	To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis	12 month
Primary	baseline and repeat administration	To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection	12 month
Secondary	Incidence of SARS-CoV-2 infection	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	12 Month
Secondary	Incidence of all-cause hospitalization and mortality	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	12 Month
Secondary	COVID-19 risk behavior at time of AZD7442	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	12 Month
Secondary	Describe health-related quality of life	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	12 Month
Secondary	describe COVID-19-related healthcare resource utilization	To describe COVID-19-related healthcare resource utilization during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection	12 Month