Study on Determine the Utilisation and Clinical Outcomes of Evusheld in COVID-19 PrEP in China

NCT05917951 | Completed

• 1 other identifier: D8850R00019
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

Evusheld(AZD7442) is a combination of 2 human long-acting antibodies, which was selected for maximal potency and demonstrated synergistic neutralization of SARS-CoV-2 in vitro. PROVENT is a Phase III study in participants at an increased risk for inadequate response to COVID-19 vaccine, an increased risk of exposure to SARS-CoV-2 or both. The study met the primary endpoint of reduction in the incidence of symptomatic Coronavirus disease 2019 (COVID-19) with tixagevimab/cilgavimab (TIXA/CILGA) compared with placebo, risk reduction 76.7% (95% CI, 46.0-90.0), in 5172 patients who did not have a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Reverse transcription polymerase chain reaction (RT-PCR) positive COVID-19 infection at baseline. Although the PROVENT trial was invaluable in demonstrating AZD7442's ability to prevent symptomatic infection, it was conducted in highly controlled environments using a rigorous protocol, which does not accurately reflect the patient experience in clinical practice. Furthermore, the sample size of Asian population in phase 3 clinical trials is small (110 subjects in AZD7442 group and 60 subjects in placebo group), and there is very limited clinical trial/real-world data in Chinese population is reported. Therefore, this current study aims to describe the utilisation and clinical outcomes of AZD7442 in Chinese population for pre-exposure prophylaxis.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis

  * Proportion of individuals by demographic variables of interest (e.g. age, gender, race/ethnicity, smoking status, weight(kg) and height(cm) will be combined to reported body mass index(BMI) in kg/m\^2, cities of frequency travel and residence, long-term care or assisted living, household composition, high risk contacts) * Proportion of individuals by clinical characteristics of interest (e.g. comorbidities, prior and concurrent medications, including immunosuppressors by type/class) * Proportion of individuals by baseline COVID-19 vaccination status or any history of exposure to other prophylactic interventions for prevention of SARS-CoV-2 exposure. * Proportion of individuals by baseline history of SARS-CoV-2 infection/COVID-19 diagnosis and disease severity. * Proportion of individuals by priority AZD7442 subpopulations of interest

  up to 12 months before first administration of AZD7442 for pre-exposure prophylaxis

Secondary Outcomes (6)

• To describe the baseline demographic and clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis by population subgroup of key basic disease.

  up to 12 months before first administration of AZD7442 for pre-exposure prophylaxis

• 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 6 months after first administrationxposure prophylaxis of AZD7442 for pre-e

  6 months after first administration of AZD7442 for pre-exposure prophylaxis

• To describe the incidence of all-cause hospitalization and mortality during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis

  during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis

• To describe COVID-19 risk behaviours at the time of AZD7442 injection and during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis

  during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis

• To describe COVID-19-related healthcare resource utilisation (HCRU) during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis

  during the 6 months after first administration of AZD7442 for pre-exposure prophylaxis

Other Outcomes (7)

• To describe the demographic and clinical characteristics of SARS-CoV-2 infection, medically attended COVID-19, and COVID-19 related hospitalized cases occurring in comparison to non-cases.

  6 months following AZD7442 first administration for pre-exposure prophylaxis

• To describe the incidence of long COVID syndrome following AZD7442 first administration for pre-exposure prophylaxis

  12 weeks from first onset of COVID-19 symptoms

• To describe the baseline and repeat administration(s) of AZD7442

  when receive AZD7442

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants included in this this study are all individuals who have received AZD7442 since AZD7442 will be on market in China.

You may qualify if:

• Individuals receiving AZD7442 before enrolment date or have been prescribed or have planned to administrate at enrolment date.
• Individuals willing and able to sign informed consent signed.

You may not qualify if:

• Individuals currently participating in interventional clinical trials of SARS-CoV-2 prophylactic or treatments.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

(2) Ruijin-Hainan Hospital Shanghai Jiaotong University School of Medicine (Hainan Boao Research Hospital)

Qionghai, Hainan, China

Location

Related Publications (1)

• You J, Wu H, Tian J, Wen J, Shi W, Wang Z, Du Y, Xu H, Wei H, Li X, Kang W, Zhou M, Gu Z, Qu J. Real-world clinical outcomes of tixagevimab/cilgavimab in the Omicron outbreak in China: baseline characteristics and interim analysis of the CLEAR study. Virol J. 2024 Oct 24;21(1):262. doi: 10.1186/s12985-024-02509-5.

  PMID: 39448986 DERIVED

Related Links

• redacted CSR Synopsis

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jieming Qu, Doctor

  18917762988

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: June 26, 2023
• Study Start: December 24, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries Associations (EFPIA) Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: 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. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (1)