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

NCT05917951 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 248

Last updated 2024-05-29

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • Jieming Qu, Doctor · 18917762988

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-24
Primary Completion
2023-07-20
Completion
2023-07-20

Countries

  • China

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05917951 on ClinicalTrials.gov