Sotrovimab versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Obbina Abani, Amr E. Abbas, Fatima H. Abbas, Kaja Abbas, Mustafa A. Abbas, Jamil A. Abbasi, Sadia Abbasi, H Abbass, Anne L. Abbott, Nadine H. Abdallah, Ashraf Omar Abdelaziz, M Abdelfattah, Bushra Abdelqader, Annisa Mutiara Putri Abdul, Basir Abdul, Sami Aftab Abdul, Abdul A Rasheed, Rezan Abdul Kadir, Abdulfatahi Abdulmumeen, Rasheed Abdul-Raheem, Niyaz Abdulshukkoor, Kula Abdusamad, Yazeed Abed El Khaleq, Mai Abedalla, A Abeer Ul Amna, Laurent Abel, Kathy Abernethy, Movin Abeywickrema, Chandra Abhinaya, Ahmad Farid Abidin, Adebanke Aboaba, Abigail Aboagye-Odei, Christopher Aboah, Heba Aboelela, H Abo-Leyah, Karim Abouelela, Ahmed Abou-Haggar, Mahmoud Abouibrahim, Ahmed Abousamra, M Abouzaid, Mathew Puravady Abraham, Thomas Abraham, Azmeralda Abraheem, J Abrams, Richard K. Abrams, HJ Abu, Ahmad Abu-Arafeh, SM Abubacker, Akata Abung, Yousef Abdel-Kareem Abusamra, Yaa Aceampong, Amaka Achara, Dhruba Acharya, Faustina Acheampong, Paul Acheampong, Sarah Acheampong, James F Acheson, Shiella Achieng, Andres J Acosta, R Acquah, Connor Acton, Jacqueline Adabie-Ankrah, Pauline Adair, AS Adam, Fiona H. Adam, Matthew Adam, Huzaifa I. Adamali, Maryann Adamczyk, Christopher Adams, David Adams, Katie Adams, Laura E. Adams, Nicholas M. T. Adams, Richard Adams, Tempestt Adams, Laura Adamu-Ikeme, Krishma Adatia, Kim G. Adcock, L Addai-Boampong, A. Addo, Oluwafemi Adeagbo, Adewole Adesoji Adebiyi, O. S. Adedeji, Yewande Adegeye, K Adegoke, Vicki Adell, Sherna F. Adenwalla, FW Adeoye, OA Adesemoye, EO Adewunmi, A Adeyanju, Joyce Adeyemi, Titilope Adenike Adeyemo, Bidur Adhikari, SA Adhikari, R Adhikary, A Aditya, P Adjepong, Gabrielle Adkins, Ahmad Adnan, M Adriaanse, J Aeron‐Thomas, Debbie Affleck, Carmel Afnan, Muhammad Abdur Rahman Afridi, P Afrim, FA Afriyie, ZA Aftab, Agnes Awuah, Mudit Agarwal, PN Agasiya, Rachel Agbeko, C Agbo, Sandeep K Aggarwal, A Aghababaie, L A Aguilar Jimenez, JA Agyekum, K Agyen, EK Ahadome, S Ahamed Sadiq, MH Ahammed Nazeer, Saad Bilal Ahmad, A Ahmed, BAR Ahmed, Bilal Ahmed, Farhan Ahmed, Haroon Ahmed, Irshad Ahmed, Kamruddin Ahmed, Lamara Mohamed Ait Ahmed, Muhammad S. Ahmed, MC Ahmed, MS Ahmed, Nausheen Ahmed, Osama Ashraf Ahmed, R Ahmed, RA Ahmed, SG Ahmed, Sanam Ahmed, SH Ahmed, Rabeka A. Ali, Bilal A Mohamud, Sana Ahmer, Augustine Ahonia, Clement Aidoo, Christine Aiken, Dhiraj Ail, Mark Andrew Ainsworth, Myriam Aissa, L Aitken, B Ajay, Abdulakeem Ajibode, Ahdi Noomen Ajmi, Nahid Akhtar, Suha Akili, B Akinbiyi, Omowunmi Akindolie, Yinka Akinfenwa, Olugbenga Akinkugbe, Ibrahim Akinpelu, Muhammad Akram, Olugbenro Aktinade, Uzayr Akudi, ASAR Al Aaraj, Ali Al Balushi, Majd Al Dakhola, Aladdin Al Swaifi, Eslam Al‐Abadi, A Alabi, Narendra Aladangady, Mahmoud Alafifi, AHM Khurshid Alam, G. M. Monirul Alam, Shoaib Alam, Ali Kareem Najm AL-ASADI, Kyriaki S. Alatzoglou, Paul Albert, A. Albertus, Lorraine Albon, Gemma Alcorn, Stephen Alcorn, Andrés Gómez-Aldana, David Alderdice, Abdullah Aldesouki, Rayan Aldouri, Jonathan Aldridge, Nicolas Aldridge, RM Ale, Ana Alegria, Amit Alexander, Craig J. Alexander, John Hunter Alexander, PDG Alexander, Julyan Al-Fori, Laith Alghazawi, O Alhabsha, Bahij Al-Hakim, R Alhameed, M Al-Hayali, Shams Al‐Hity, Ala Ali, Faisal R. Ali, Johar Ali, Moazzam Ali, MS Ali, Nayab Ali, Rafat Ali, Syed Ahsan Ali, Emilio Aliberti, Jade Alin, Abid Alina, Analyn Alipustain, Bachti Alisjahbana, Fine Aliyuda, Kaveh Alizadeh, Maithem Al-Jibury, Saja Al-Juboori, A Alkhudhayri, Moutaz Alkhusheh, Frank N. Allan, Nicholas P. Allan, Alison Allanson, Robert Allcock, Emma C. Allen, Julie Allen, Keeley Allen, Louise E. Allen, Pamela B. Allen, R Allen, Stephen John Allen, Tammy D. Allen, A Alli, Kelly C. Allison, Brent E. Allman, HK Allsop, Lynne Allsop, David John Allsup, AFT Almahroos, Hassan Al-Moasseb, M Al-Obaidi, Lina Alomari, Akram Al-Rabahi, Bahar Al-Ramadhani, Z Al-Saadi, Riyam Al-Sammarraie, Inji Alshaer, Rustam Al‐Shahi Salman, Warkaq Al-Shamkhani, F Alsheikh, Bashar Al-Sheklly, Sana Altaf, A Alty, Míriam J. Álvarez, Maria Alvarez Corral, Edward Alveyn, Maysaa Alzetani, Susan Amamou, N. Amar, S Ambalavanan, Robert Ambrogetti, Christopher S. Ambrose, A Ameen, Kate Ames, M. R. 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Campbell, Marilyn Anne Campbell, Ryan J Campbell, W Campbell, Quentin Campbell Hewson, Julie Camsooksai, Lisa Canclini, SM Candido, Cielito Caneja, A Cann, J Cann, Ruby Cannan, Andréa Cannon, Eileen Cannon, Mary D Cannon, Paul Cannon, V Cannons, Ebnier Canonizado, Jane Cantliff, Neşe Kanbal Çap, Ben Caplin, Santino Capocci, Noemi Caponi, Anne Capp, Richard Capstick, Toby Capstick, Catalin Caraenache, Aimee Card, Michael D. Cardwell, Charles Carey, Rachel Carey, Simon David Carley, Ffion Carlin, Tammy Carlin, Stacy Koser Carmichael, M. Carmody, Mandy Carnahan, Charlotte Caroline, James R. Carpenter, Sue Carr, Araceli Ramos Carrasco, Z Carrington, A Carroll, Paul A Carroll, Richard T. Carson, C Cart, E Carter, Jonathan R. Carter, Madison W. Carter, N Carter, P Carter, Douglas Cartwright, J-A Cartwright, Cara L. Carty, Lucy Carty, Jaime Carungcong, Catherine Carver, Emma Carver, Richard Carver, Susan A. Casey, Andrea N. Cassells, Teresa Castiello, G. Castle, Bridget Castles, M. 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Le résumé fourni par la source
BACKGROUND: Sotrovimab is a neutralising monoclonal antibody targeting the SARS-CoV-2 spike protein. We aimed to evaluate the efficacy and safety of sotrovimab in the RECOVERY trial, an investigator-initiated, individually randomised, controlled, open-label, adaptive platform trial testing treatments for patients admitted to hospital with COVID-19. METHODS: Patients admitted with COVID-19 pneumonia to 107 UK hospitals were randomly assigned (1:1) to either usual care alone or usual care plus a single 1 g infusion of sotrovimab, using web-based unstratified randomisation. Participants were eligible if they were aged at least 18 years, or aged 12-17 years if weighing at least 40kg, and had confirmed COVID-19 pneumonia with no medical history that would put them at significant risk if they participated in the trial. Participants were retrospectively categorised as having a high antigen level if baseline serum SARS-CoV-2 nucleocapsid antigen was above the median concentration (the prespecified primary efficacy population), otherwise they were categorised as having a low antigen level. The primary outcome was 28-day mortality assessed by intention to treat. Safety outcomes were assessed among all participants, regardless of antigen level. Recruitment closed on March 31, 2024, when funding ended. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). FINDINGS: From Jan 4, 2022, to March 19, 2024, 1723 patients were enrolled in the RECOVERY sotrovimab comparison. Of these, 828 (48%) were assigned to usual care plus sotrovimab and 895 (52%) were assigned to usual care only. Mean patient age was 70·7 years (SD 14·8) and 1033 (60%) were male. 720 (42%) patients were classified as having a high antigen level, 717 (42%) as having a low antigen level, and 286 (17%) had unknown antigen status. 1389 (81%) patients were vaccinated, 1179 (82%) of 1438 patients with known serostatus had anti-spike antibodies at randomisation, and 1021 (>99%) of 1026 patients with sequenced samples were infected with omicron variants. Among patients with a high antigen level, 82 (23%) of 355 assigned to sotrovimab versus 106 (29%) of 365 assigned usual care died within 28 days (rate ratio 0·75, 95% CI 0·56-0·99; p=0·046). In an analysis of all randomly assigned patients (regardless of antigen status), 177 (21%) of 828 patients assigned to sotrovimab versus 201 (22%) of 895 assigned to usual care died within 28 days (0·95, 0·77-1·16; p=0·60). Infusion reactions were recorded in 12 (2%) of 781 patients receiving sotrovimab. We found no difference between groups in any other safety outcome. INTERPRETATION: In patients admitted to hospital with COVID-19 pneumonia, sotrovimab was associated with reduced mortality in the primary analysis population who had a high serum SARS-CoV-2 antigen concentration at baseline, but not in the overall population. Treatment options for patients admitted to hospital are limited, and mortality in those receiving current standard of care was high. The emergence of high-level resistance to sotrovimab among subsequent SARS-CoV-2 variants restricts its current usefulness, but these results indicate that targeted neutralising antibody therapy could potentially still benefit some patients admitted to hospital who are at high risk of death in an era of widespread vaccination and omicron infection. FUNDING: UK Research and Innovation (Medical Research Council) and National Institute for Health and Care Research.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Sotrovimab versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
- Date Crossref
- 01/01/2026
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.