Clinical trial NCT05315323: Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
AZD7442
EVUSHELD
Real-world Setting
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Demographics
timeFrame: 12 month
measure: clinical characteristics
timeFrame: 12 month
measure: baseline and repeat administration
timeFrame: 12 month
Secondary outcomes:
measure: Incidence of SARS-CoV-2 infection
timeFrame: 12 Month
measure: Incidence of all-cause hospitalization and mortality
timeFrame: 12 Month
measure: COVID-19 risk behavior at time of AZD7442
timeFrame: 12 Month
measure: Describe health-related quality of life
timeFrame: 12 Month
measure: describe COVID-19-related healthcare resource utilization
timeFrame: 12 Month
Other outcomes:
measure: Describe the demographic and clinical characteristics
timeFrame: 12 Month
measure: Describe the incidence of long COVID syndrome
timeFrame: 12 Month
measure: Describe all-cause HCRU
timeFrame: 12 Month
measure: Describe COVID-19-related work loss/school absenteeism
timeFrame: 12 Month
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
Study officials:
References: