Sotrovimab versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: The Lancet Infectious Diseases
Authors: O Abani, A Abbas, F Abbas, K Abbas, M Abbas, J Abbasi, S Abbasi, H Abbass, A Abbott, N Abdallah, A Abdelaziz, M Abdelfattah, B Abdelqader, A Abdul, B Abdul, S Abdul, A Abdul Rasheed, A Abdulakeem, R Abdul-Kadir, A Abdullah, A Abdulmumeen, R Abdul-Raheem, N Abdulshukkoor, K Abdusamad, Y Abed El Khaleq, M Abedalla, A Abeer Ul Amna, L Abel, K Abernethy, M Abeywickrema, C Abhinaya, A Abidin, A Aboaba, A Aboagye-Odei, C Aboah, H Aboelela, H Abo-Leyah, K Abouelela, A Abou-Haggar, M Abouibrahim, A Abousamra, M Abouzaid, M Abraham, T Abraham, A Abraheem, J Abrams, R Abrams, HJ Abu, A Abu-Arafeh, SM Abubacker, A Abung, Y Abusamra, Y Aceampong, A Achara, D Acharya, F Acheampong, P Acheampong, S Acheampong, J Acheson, S Achieng, A Acosta, R Acquah, C Acton, J Adabie-Ankrah, P Adair, AS Adam, F Adam, M Adam, H Adamali, M Adamczyk, C Adams, D Adams, K Adams, L Adams, N Adams, R Adams, T Adams, L Adamu-Ikeme, K Adatia, K Adcock, L Addai-Boampong, A Addo, O Adeagbo, A Adebiyi, O Adedeji, Y Adegeye, K Adegoke, V Adell, S Adenwalla, FW Adeoye, OA Adesemoye, EO Adewunmi, A Adeyanju, J Adeyemi, T Adeyemo, B Adhikari, SA Adhikari, R Adhikary, A Aditya, P Adjepong, G Adkins, A Adnan, M Adriaanse, J Aeron-Thomas, D Affleck, C Afnan, M Afridi, P Afrim, FA Afriyie, ZA Aftab, A Afum-Adjei Awuah, M Agarwal, PN Agasiya, R Agbeko, C Agbo, S Aggarwal, A Aghababaie, L Aguilar Jimenez, JA Agyekum, K Agyen, EK Ahadome, S Ahamed Sadiq, MH Ahammed Nazeer, M Ahmad, S Ahmad, A Ahmed, BAR Ahmed, B Ahmed, F Ahmed, H Ahmed, I Ahmed, K Ahmed, L Ahmed, M Ahmed, MC Ahmed, MS Ahmed, N Ahmed, O Ahmed, R Ahmed, RA Ahmed, SG Ahmed, S Ahmed, SH Ahmed, R Ahmed Ali, B Ahmed Mohamud, S Ahmer, A Ahonia, C Aidoo, C Aiken, D Ail, M Ainsworth, M Aissa, L Aitken, B Ajay, A Ajibode, A Ajmi, N Akhtar, S Akili, B Akinbiyi, O Akindolie, Y Akinfenwa, O Akinkugbe, I Akinpelu, M Akram, O Aktinade, U Akudi, ASAR Al Aaraj, A Al Balushi, M Al Dakhola, A Al Swaifi, E Al-Abadi, A Alabi, N Aladangady, M Alafifi, A Alam, GF Alam, S Alam, A Al-Asadi, K Alatzoglou, P Albert, A Albertus, L Albon, A Alcala, G Alcorn, S Alcorn, A Aldana, D Alderdice, A Aldesouki, R Aldouri, J Aldridge, N Aldridge, RM Ale, A Alegria, A Alexander, C Alexander, J Alexander, PDG Alexander, J Al-fori, L Alghazawi, O Alhabsha, B Al-Hakim, R Alhameed, M Al-Hayali, S Al-Hity, A Ali, F Ali, J Ali, M Ali, MS Ali, N Ali, O Ali, R Ali, S Ali, E Aliberti, J Alin, A Alina, A Alipustain, B Alisjahbana, F Aliyuda, K Alizadeh, M Al-Jibury, S Al-Juboori, M Al-Khalil, A Alkhudhayri, M Alkhusheh, F Allan, N Allan, A Allanson, R Allcock, E Allen, J Allen, K Allen, L Allen, P Allen, R Allen, S Allen, T Allen, A Alli, K Allison, B Allman, HK Allsop, L Allsop, D Allsup, AFT Almahroos, H Al-Moasseb, M Al-Obaidi, L Alomari, A Al-Rabahi, B Al-Ramadhani, Z Al-Saadi, R Al-Sammarraie, I Alshaer, R Al-Shahi Salman, W Al-Shamkhani, F Alsheikh, B Al-Sheklly, S Altaf, A Alty, M Alvarez, M Alvarez Corral, E Alveyn, M Alzetani, S Amamou, N Amar, S Ambalavanan, R Ambrogetti, C Ambrose, A Ameen, K Ames, MR Amezaga, A Amin, K Amin, S Amin, T Amin, B Amit, A Amjad, N Amjad, J Amoah-Dankwa, A Amoako Adusei, V Amosun, M Amsal, K Amsha, J Amuasi, N Amutio Martin, P Amy, A Anada, A Anand, S Anandappa, SD Anantapatnaikuni, NKN Andari, E Anderson, J Anderson, L Anderson, M Anderson, N Anderson, R Anderson, S Anderson, W Anderson, P Andreou, A Andrews, J Andrews, K Aneke, A Ang, WW Ang, T Angel, P Angelini, L Anguvaa, O Anichtchik, M Anim-Somuah, K Aniruddhan, J Annett, L Anning, M Ansah, PJ Anstey, R Anstey, A Anthony, A Anthony-Pillai, P Antill, Z Antonina, V Anu, M Anwar, S Anwar, E Apetri, A Apostolopoulos, S Appleby, D Appleyard, MF Aquino, B Araba, A Aramburo, S Aransiola, M Araujo, A Archer, D Archer, S Archer, D Arcoria, C Ardley, G Arhin-Sam, A-M Arias, O Aribike, R Arimoto, NLPE Arisanti, C Arkley, C Armah, I Armata, J Armistead, A Armitage, C Armstrong, M Armstrong, S Armstrong, W Armstrong, P Armtrong, H Arndt, C Arnison-Newgass, D Arnold, R 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McLure, AM McMahon, G McMahon, M McMahon, S McMahon, T McManus, M McMaster, P McMaster, F Mcmeeken, S McMeekin, N McMillan, K McMillen, J McMinn, L McMorrow, H McMullen, C McMurran, H McNally, F McNeela, L McNeil, C McNeill, J McNeill, S McNeill, U McNelis, M McNulty, R McNulty, C McParland, M McPhail, A McQueen, A McSkeane, D McSorland, T McSorley, G McTaggart, J McTaggart, J Mead, P Mead, E Meadows, O Meakin, B Mearns, C Mearns, K Mears, W Mears, M Meda, A Mediana, R Medine, T Medveczky, S Meehan, E Meeks, A Megan, N Meghani, S Meghjee, S Megson, A Mehar, MN Mehmood, R Mehra, R Mehta, G Meintjes, J Meirill, J Meiring, R Mejri, E Mekonnen, S Melander, A-S Melinte, J Mellersh, L Melling, C Mellish, F Mellor, J Mellor, S Mellor, Z Mellor, K Mellows, V Melnic, A Melville, D Melville, J Melville, H Membrey, M Mencias, A Mendelski, M Mendelson, C Mendonca, C Meney, C Menezes, W Mensah, J Mensshan, A Mentzer, D Menzies, S Menzies, S Mepham, O Mercer, P Mercer, A Merchant, F Merchant, M 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Murtagh, M Murthy, C Murton, R Murton, N Muru, R Musanhu, M Mushabe, O Mushtaq, S Musini, AMM Mustafa, E Mustafa, M Mustafa, I Mustapha, N Mustfa, Z Mustufvi, C Mutch, R Mutch, E Mutema, B Muthukrishnan, S Mutton, N Muzengi, M Mwadeyi, B Mwale, E Mwaura, R Myagerimath, A Myers, S Myers, J Myerson, K Myint, Y Myint, G Mynott, L Myslivecek, P Nabayego, E Nadar, I Nadeem, M Nadheem, B Nadjm, A Naeem, H Naeem, S Naeem, S Nafees, M Nafei, W Naftalia, T Nagarajan, L Naglik, I Nagra, D Nagra, M Naguib, K Naguleswaran, KS Nagumantry, K Naicker, S Naidoo, V Naidoo, G Naik, R Naik, S Naik, DS Nair, R Nair, T Nair, J Naisbitt, K Naismith, D Nakiboneka-Ssenabulya, S Nallapareddy, S Nallapeta, A Nallasivan, H Nam, U Nanda, A Nandani, T Nandwani, A Naqvi, S Naqvi, S Nasa, D Nash, N Nasheed, A Nasimudeen, U Nasir, N Nasronudin
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $7,280
Funders: Bill and Melinda Gates Foundation, Regeneron Pharmaceuticals, Wellcome Trust, UK Research and Innovation, National Institute for Health and Care Research, Department of Health and Social Care, University of Oxford, Medical Research Council, NIHR Oxford Biomedical Research Centre, NIHR Nottingham Biomedical Research Centre, Health Data Research UK
OpenAlex ID: W4413813131