دورية أكاديمية
أعرض في EDS

Real-world effectiveness of an intranasal spray A8G6 antibody cocktail in the post-exposure prophylaxis of COVID-19.

التفاصيل البيبلوغرافية
العنوان: Real-world effectiveness of an intranasal spray A8G6 antibody cocktail in the post-exposure prophylaxis of COVID-19.
المؤلفون: Li X; Clinical Molecular Medicine Testing Center, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.; Key Laboratory of Major Brain Disease and Aging Research (Ministry of Education), Institute for Brain Science and Disease, Chongqing Medical University, Chongqing, 400016, China., Peng P; Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Department of Infectious Diseases, Chongqing Medical University, Chongqing, China.; Institute for Viral Hepatitis, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China., Deng H; Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Department of Infectious Diseases, Chongqing Medical University, Chongqing, China.; Institute for Viral Hepatitis, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China., Yang Q; Clinical Molecular Medicine Testing Center, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China., Chen S; Clinical Molecular Medicine Testing Center, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China., Li B; Clinical Molecular Medicine Testing Center, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China., He M; Laboratory Animal Center of Chongqing Medical University, Chongqing, China., Jin A; Department of Immunology, College of Basic Medicine, Chongqing Medical University, Chongqing, 400010, China.; Chongqing Key Laboratory of Basic and Translational Research of Tumor Immunology, Chongqing Medical University, Chongqing, 400010, China., Yang Z; Department of Gynecology and Obstetrics, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China., Tang N; Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Department of Infectious Diseases, Chongqing Medical University, Chongqing, China. nitang@cqmu.edu.cn.; Institute for Viral Hepatitis, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. nitang@cqmu.edu.cn., Huang A; Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Department of Infectious Diseases, Chongqing Medical University, Chongqing, China. ahuang@cqmu.edu.cn.; Institute for Viral Hepatitis, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. ahuang@cqmu.edu.cn.
المصدر: Signal transduction and targeted therapy [Signal Transduct Target Ther] 2023 Oct 23; Vol. 8 (1), pp. 403. Date of Electronic Publication: 2023 Oct 23.
نوع المنشور: Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101676423 Publication Model: Electronic Cited Medium: Internet ISSN: 2059-3635 (Electronic) Linking ISSN: 20593635 NLM ISO Abbreviation: Signal Transduct Target Ther Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : Nature Publishing Group, [2016]-
مواضيع طبية MeSH: COVID-19*, Humans ; Combined Antibody Therapeutics ; SARS-CoV-2 ; Post-Exposure Prophylaxis ; Antibodies, Neutralizing
مستخلص: Previously, we identified an antibody combination A8G6 that showed promising efficacy in COVID-19 animal models and favorable safety profile in preclinical models as well as in a first-in-human trial. To evaluate the real-word efficacy of A8G6 neutralizing antibody nasal spray in post-exposure prophylaxis of COVID-19, an open-label, non-randomized, two-arm, blank-controlled, investigator-initiated trial was conducted in Chongqing, China (the register number: ChiCTR2200066416). High-risk healthy participants (18-65 years) within 72 h after close contact to COVID-19 patients were recruited and received a three-dose (1.4 mg/dose) A8G6 treatment daily or no treatment (blank control) for 7 consecutive days. SARS-CoV-2 infection occurred in 151/340 (44.4%) subjects in the blank control group and 12/173 (6.9%) subjects in the A8G6 treatment group. The prevention efficacy of the A8G6 treatment within 72 h exposure was calculated to be 84.4% (95% CI: 74.4-90.4%). Moreover, compared to the blank-control group, the time from the SARS-CoV-2 negative to the positive COVID-19 conversion was significantly longer in the AG86 treatment group (mean time: 3.4 days vs 2.6 days, p = 0.019). In the secondary end-point analysis, the A8G6 nasal treatment had no effects on the viral load at baseline SARS-CoV-2 RT-PCR positivity and the time of the negative COVID-19 conversion. Finally, except for 5 participants (3.1%) with general adverse effects, we did not observe any severe adverse effects related to the A8G6 treatment. In this study, the intranasal spray AG86 antibody cocktail showed potent efficacy for prevention of SARS-CoV-2 infection in close contacts of COVID-19 patients.
(© 2023. West China Hospital, Sichuan University.)
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المشرفين على المادة: 0 (Combined Antibody Therapeutics)
0 (Antibodies, Neutralizing)
تواريخ الأحداث: Date Created: 20231022 Date Completed: 20231026 Latest Revision: 20231123
رمز التحديث: 20231123
مُعرف محوري في PubMed: PMC10590774
DOI: 10.1038/s41392-023-01656-5
PMID: 37867182
قاعدة البيانات: MEDLINE
الوصف
تدمد:2059-3635
DOI:10.1038/s41392-023-01656-5