Academic Journal
Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial
| العنوان: | Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial |
|---|---|
| المؤلفون: | Ginde, AA, Paredes, R, Murray, TA, Engen, N, Grandits, G, Vekstein, A, Ivey, N, Mourad, A, Sandkovsky, U, Gottlieb, RL, Berhe, M, Jain, MK, Marines-Price, R, Agbor Agbor, BT, Mateu, L, España-Cueto, S, Lladós, G, Mylonakis, E, Rogers, R, Shehadeh, F, Filbin, MR, Hibbert, KA, Kim, K, Tran, T, Morris, PE, Cassity, EP, Trautner, B, Pandit, LM, Knowlton, KU, Leither, L, Matthay, MA, Rogers, AJ, Drake, W, Jones, B, Poulakou, G, Syrigos, KN, Fernández-Cruz, E, Natale, MD, Almasri, E, Balerdi-Sarasola, L, Bhagani, SR, Boyle, KL, Casey, JD, Chen, P, Douin, DJ, Files, DC, Günthard, HF, Hite, RD, Hyzy, RC, Khan, A, Kibirige, M, Kidega, R, Kiweewa, F, Jensen, JU, Leshnower, BG, Lutaakome, JK, Manian, P, Menon, V, Morales-Rull, JL, O'Mahony, DS, Overcash, JS, Ramachandruni, S, Steingrub, JS, Taha, HS, Waters, M, Young, BE, Phillips, AN, Murray, DD, Jensen, TO, Padilla, ML, Sahner, D, Shaw-Saliba, K, Dewar, RL, Teitelbaum, M, Natarajan, V, Rehman, MT, Pett, S, Hudson, F, Touloumi, G, Brown, SM, Self, WH, Chang, CC, Sánchez, A, Weintrob, AC, Hatlen, T, Grund, B, Sharma, S, Reilly, CS, Garbes, P, Esser, MT, Templeton, A, Babiker, AG, Davey, VJ, Gelijns, AC, Higgs, ES, Kan, V, Matthews, G, Thompson, BT, Neaton, JD, Lane, HC |
| المصدر: | The Lancet Respiratory Medicine , 10 (10) pp. 972-984. (2022) |
| بيانات النشر: | Elsevier BV |
| سنة النشر: | 2022 |
| المجموعة: | University College London: UCL Discovery |
| مصطلحات موضوعية: | Adult, Antibodies, Monoclonal, Neutralizing, COVID-19, Double-Blind Method, Humans, Treatment Outcome |
| الوصف: | Background: Tixagevimab–cilgavimab is a neutralising monoclonal antibody combination hypothesised to improve outcomes for patients hospitalised with COVID-19. We aimed to compare tixagevimab–cilgavimab versus placebo, in patients receiving remdesivir and other standard care. Methods: In a randomised, double-blind, phase 3, placebo-controlled trial, adults with symptoms for up to 12 days and hospitalised for COVID-19 at 81 sites in the USA, Europe, Uganda, and Singapore were randomly assigned in a 1:1 ratio to receive intravenous tixagevimab 300 mg–cilgavimab 300 mg or placebo, in addition to remdesivir and other standard care. Patients were excluded if they had acute organ failure including receipt of invasive mechanical ventilation, extracorporeal membrane oxygenation, vasopressor therapy, mechanical circulatory support, or new renal replacement therapy. The study drug was prepared by an unmasked pharmacist; study participants, site study staff, investigators, and clinical providers were masked to study assignment. The primary outcome was time to sustained recovery up to day 90, defined as 14 consecutive days at home after hospital discharge, with co-primary analyses for the full cohort and for participants who were neutralising antibody-negative at baseline. Efficacy and safety analyses were done in the modified intention-to-treat population, defined as participants who received a complete or partial infusion of tixagevimab–cilgavimab or placebo. This study is registered with ClinicalTrials.gov, NCT04501978 and the participant follow-up is ongoing. Findings: From Feb 10 to Sept 30, 2021, 1455 patients were randomly assigned and 1417 in the primary modified intention-to-treat population were infused with tixagevimab–cilgavimab (n=710) or placebo (n=707). The estimated cumulative incidence of sustained recovery was 89% for tixagevimab–cilgavimab and 86% for placebo group participants at day 90 in the full cohort (recovery rate ratio [RRR] 1·08 [95% CI 0·97–1·20]; p=0·21). Results were similar in the seronegative ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text |
| اللغة: | English |
| Relation: | https://discovery.ucl.ac.uk/id/eprint/10161687/1/Tixagevimab%20cilgavimab%20for%20treatment%20of%20patients%20hospitalised%20with%20COVID%2019.pdf; https://discovery.ucl.ac.uk/id/eprint/10161687/ |
| الاتاحة: | https://discovery.ucl.ac.uk/id/eprint/10161687/1/Tixagevimab%20cilgavimab%20for%20treatment%20of%20patients%20hospitalised%20with%20COVID%2019.pdf https://discovery.ucl.ac.uk/id/eprint/10161687/ |
| Rights: | open |
| رقم الانضمام: | edsbas.F04D95D2 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |