COVID-19
Conditions
Keywords
COVID-19, SARS-CoV-2, AZD7442, EVUSHELD, Real-world Setting
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | 12 month | To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis |
| baseline and repeat administration | 12 month | To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection |
| clinical characteristics | 12 month | To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 risk behavior at time of AZD7442 | 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 |
| Incidence of SARS-CoV-2 infection | 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 |
| Incidence of all-cause hospitalization and mortality | 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 |
| Describe health-related quality of life | 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 |
| describe COVID-19-related healthcare resource utilization | 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
| Measure | Time frame | Description |
|---|---|---|
| Describe the incidence of long COVID syndrome | 12 Month | To describe the incidence of long COVID syndrome following AZD7442 administration for prevention of SARS-CoV-2 infection |
| Describe COVID-19-related work loss/school absenteeism | 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 |
| Describe the demographic and clinical characteristics | 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 |
| Describe all-cause HCRU | 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 |
Countries
United Arab Emirates
Outcome results
None listed