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c19early.org COVID-19 treatment researchTixagevimab/cilgavimabTixagev../c.. (more..)
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Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period

Fomina et al., Frontiers in Immunology, doi:10.3389/fimmu.2023.1259725, NCT05982704, Oct 2023
https://c19early.org/fomina.html
41st treatment shown to reduce risk in May 2022, now with p = 0.0066 from 19 studies, recognized in 33 countries. Efficacy is variant dependent.
Lower risk for mortality, hospitalization, and cases.
No treatment is 100% effective. Protocols combine treatments.
6,000+ studies for 175 treatments. c19early.org
Prospective study of 77 COVID-19 outpatients showing improved efficacy with tixagevimab/cilgavimab compared to regdanvimab during Omicron variant dominance.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, BQ.1.11, BA.5, BA.2.75, XBB2,3, XBB.1.53, ХВВ.1.9.13, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.14.
Study covers tixagevimab/cilgavimab and regdanvimab.
Fomina et al., 20 Oct 2023, prospective, Russia, peer-reviewed, 16 authors, study period 20 August, 2022 - 1 February, 2023, this trial compares with another treatment - results may be better when compared to placebo, trial NCT05982704 (history). Contact: marina.ivanova0808@yandex.ru.
Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period
Daria S Fomina, Marina S Lebedkina, Anna A Iliukhina, Anna V Kovyrshina, Artem Y Shelkov, Sergey S Andreev, Anton A Chernov, Inna V Dolzhikova, Tatyana S Kruglova, Gerelma V Andrenova, Amir I Tukhvatulin, Dmitry V Shcheblyakov, Alexander V Karaulov, Maryana A Lysenko, Denis Y Logunov, Alexander L Gintsburg
Frontiers in Immunology, doi:10.3389/fimmu.2023.1259725
Several virus-neutralizing monoclonal antibodies (mAbs) have become new tools in the treatment of the coronavirus disease (COVID-19), but their effectiveness against the rapidly mutating virus is questionable. The present study investigated the effectiveness of Tixagevimab/Cilgavimab and Regdanvimab for mild and moderate COVID-19 treatment in real-world clinical practice during the Omicron variant-dominant period. Patients with known risk factors for disease progression and increasing disease severity were enrolled in the study within the first 7 days of symptom onset. Seventy-seven patients were divided into four groups: first 15 patients received 300 mg Tixagevimab/Cilgavimab intravenously (IV) and 23 patients got the same drug 300 mg intramuscularly (IM), the next 15 patients was on the same combination in dose of 600 mg IV, and 24 patients were on Regdanvimab at a dose of 40 mg/kg IV. By Day 4, 100% of Tixagevimab/ Cilgavimab IV patients showed negative polymerase chain reaction results for SARS-CoV-2 Ribonucleic acid (RNA) regardless of the mAbs dose while in the Regdanvimab group 29% of the patients were positive for SARS-CoV-2 virus RNA. The testing for virus neutralizing antibodies (nAbs) to various Omicron sublineages (BA.1, BA.2, and BA.5) showed that an increase in nAb levels was detected in blood serum immediately after the drug administration only in Tixagevimab/Cilgavimab 300 mg and 600 mg IV groups. In the group of Frontiers in Immunology frontiersin.org 01
Ethics statement The studies involving humans were approved by Local ethics committee City Clinical Hospital 52 (version 1.1 of 478 08.09.2022). The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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DOI record: { "DOI": "10.3389/fimmu.2023.1259725", "ISSN": [ "1664-3224" ], "URL": "http://dx.doi.org/10.3389/fimmu.2023.1259725", "abstract": "<jats:p>Several virus-neutralizing monoclonal antibodies (mAbs) have become new tools in the treatment of the coronavirus disease (COVID-19), but their effectiveness against the rapidly mutating virus is questionable. The present study investigated the effectiveness of Tixagevimab/Cilgavimab and Regdanvimab for mild and moderate COVID-19 treatment in real-world clinical practice during the Omicron variant-dominant period. Patients with known risk factors for disease progression and increasing disease severity were enrolled in the study within the first 7 days of symptom onset. Seventy-seven patients were divided into four groups: first 15 patients received 300 mg Tixagevimab/Cilgavimab intravenously (IV) and 23 patients got the same drug 300 mg intramuscularly (IM), the next 15 patients was on the same combination in dose of 600 mg IV, and 24 patients were on Regdanvimab at a dose of 40 mg/kg IV. By Day 4, 100% of Tixagevimab/Cilgavimab IV patients showed negative polymerase chain reaction results for SARS-CoV-2 Ribonucleic acid (RNA) regardless of the mAbs dose while in the Regdanvimab group 29% of the patients were positive for SARS-CoV-2 virus RNA. The testing for virus neutralizing antibodies (nAbs) to various Omicron sublineages (BA.1, BA.2, and BA.5) showed that an increase in nAb levels was detected in blood serum immediately after the drug administration only in Tixagevimab/Cilgavimab 300 mg and 600 mg IV groups. 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