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1. Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial

Author

Andrew Metcalfe, Helen Parsons, Nicholas Parsons, Jaclyn Brown, Josephine Fox, Elke Gemperlé Mannion, Aminul Haque, Charles Hutchinson, Rebecca Kearney, Iftekhar Khan, Tom Lawrence, James Mason, Nigel Stallard, Martin Underwood, Stephen Drew, Azra Arif, Susanne Arnold, Gev Bhabra, Sunayna Bora, Howard Bush, Jo Fox, Ceri Jones, Thomas Lawrence, Kerri McGowan, Chetan Modi, Bushra Rahman, Usama Rahman, Maria Ramirez, Marta Spocinska, Joanna Teuke, Varjithan Thayalan, Sumayyah Ul-Rahman, Aparna Viswanath, Iain Packham, Elizabeth Barnett, Rian Witham, Mark Crowther, Richard Murphy, Katherine Coates, Josephine Morley, Stephen Barnfield, Sukhdeep Gill, Alistair Jones, Ruth Halliday, Sarah Dunn, James Fagg, Peter Dacombe, Rajesh Nanda, Deborah Wilson, Lesley Boulton, Raymond Liow, Richard Jeavons, Andrea Meddes, Niel Kang, Leila Dehghani, Aileen Nacorda, Anuj Punnoose, Nicholas Ferran, Gbadebo Adewetan, Temi Adedoyin, Arun Pall, Matthew Sala, Tariq Zaman, Richard Hartley, Charif a-Sayyad, Luke Vamplew, Elizabeth Howe, Norbert Bokor, Steve Corbett, Robert Moverley, Elise Cox, Oliver Donaldson, Michael Jones, Diane Wood, Jess Perry, Alison Lewis, Linda Howard, Kate Beesley, Luke Harries, Ahmed Elmorsy, Katherine Wilcocks, Kate Shean, Sarah Diment, Helen Pidgeon, Victoria King, Soren Sjolin, Angharad Williams, Joanne Kellett, Lora Young, Michael Dunne, Tom Lockwood, Mark Curtis, Nashat Siddiqui, India Mckenley, Sarah Morrison, Charlotte Morrison, Tracey O'Brien, Isabel Bradley, Kenneth Lambatan, Cormac Kelly, Charlotte Perkins, Teresa Jones, Tessa Rowlands, Dawn Collins, Claire Nicholas, Claire Birch, Julie Lloyd -Evans, Pouya Akhbari, Jefin Jose Edakalathu, Campbell Hand, Andy Cole, Debbie Prince, Kerry Thorpe, Louise Rooke, Maria Baggot, Matt Morris, Dima Ivanova, David Baker, Tim Matthews, Jessica Falatoori, Heather Jarvis, Debbie Jones, Matthew Williams, Richard Evans, Huw Pullen, Gemma Hodkinson, Nicola Vannet, Alison Davey, Emma Poyser, Angela Hall, Hemang Mehta, Devi Prakash Tokola, Clare Connor, Caroline Jordan, Owain Ennis, Zohra Omar, Tracy Lewis, Angharad Lisa Owen, Andrew Morgan, Ravi Ponnada, Waheeb Al-Azzani, Carolyn Williams, Liam Knox, Harvinder Singh, Tracy Lee, Kathryn Robinson, Dileep Kumar, Alison Armstrong, Addie Majed, Mark Falworth, David Butt, Deborah Higgs, Will Rudge, Ben Hughes, Esther Hanison, Deirdre Brooking, Amit Patel, Andrew Symonds, Jenifer Gibson, Rodney Santiago, David Barlow, Joanne Lennon, Christopher Smith, Jane Hall, Emily Griffin, Rebecca Lear, William Thomas, David Rose, Janet Edkins, Helen Samuel, Hagen Jahnich, John Geoghegan, Ben Gooding, Siobhan Hudson, Jess Nightingale, Madhavan Papanna, Tom Briggs, Rebecca Pugh, Amy Neal, Lisa Warrem, Veronica Maxwell, Robert Chadwick, Thomas Jaki, Loretta Davies, Stephen Gwilym, Rod Taylor, Geoffrey Abel, John Graham, Christopher Littlewood, Angus Wallace, and Anthony Howard

Subjects
Male, Arthroscopy, Shoulder, Treatment Outcome, Shoulder Pain, Humans, Female, General Medicine, Muscle, Skeletal, RD, Rotator Cuff Injuries
Abstract

New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Published
2022
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2. Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage: a randomised, open-label, assessor-blinded, pilot phase, non-inferiority trial

Author

Rustam Al-Shahi Salman, Catriona Keerie, Jacqueline Stephen, Steff Lewis, John Norrie, Martin S. Dennis, David E. Newby, Joanna M. Wardlaw, Gregory Y.H. Lip, Adrian Parry-Jones, Philip M. White, Colin Baigent, Dan Lasserson, Colin Oliver, Fiach O'Mahony, Shannon Amoils, John Bamford, Jane Armitage, Jonathan Emberson, Gabriël J.R. Rinkel, Gordon Lowe, Karen Innes, Kasia Adamczuk, Lynn Dinsmore, Jonathan Drever, Garry Milne, Allan Walker, Aidan Hutchison, Carol Williams, Ruth Fraser, Rosemary Anderson, Kate Covil, Kelly Stewart, Jessica Rees, Peter Hall, Alistair Bullen, Andrew Stoddart, Tom J. Moullaali, Jeb Palmer, Eleni Sakka, Joanne Perthen, Nicola Lyttle, Neshika Samarasekera, Allan MacRaild, Seona Burgess, Jessica Teasdale, Michelle Coakley, Pat Taylor, Gordon Blair, William Whiteley, Susan Shenkin, Una Clancy, Malcolm Macleod, Rachel Sutherland, Tom Moullaali, Amanda Barugh, Christine Lerpiniere, Fiona Moreton, Nicholas Fethers, Tal Anjum, Manju Krishnan, Peter Slade, Sharon Storton, Marie Williams, Caroline Davies, Lynda Connor, Glyn Gainard, Carl Murphy, Mark Barber, Derek Esson, James Choulerton, Louise Shaw, Suzanne Lucas, Sarah Hierons, Joanne Avis, Andrew Stone, Lukuman Gbadamoshi, Telma Costa, Lauren Pearce, Kirsty Harkness, Emma Richards, Jo Howe, Christine Kamara, Ralf Lindert, Ali Ali, Jahanzeb Rehan, Sarah Chapman, Maria Edwards, Raj Bathula, David Cohen, Joseph Devine, Mushiya Mpelembue, Priya Yesupatham, Swati Chhabra, Gbadebo Adewetan, Robert Ballantine, Daniel Brooks, Gemma Smith, Gill Rogers, Stuart Marsden, Sarah Clark, Ami Wilkinson, Ellen Brown, Lynsey Stephenson, Khin Nyo, Annie Abraham, Yogish Pai, Gek Shim, Vidya Baliga, Anand Nair, Matthew Robinson, Catherine Hawksworth, Jill Greig, Irfan Alam, Tonicha Nortcliffe, Ridha Ramiz, Ryan Shaw, Stephanie Lee, Tracy Marsden, Jane Perez, Emily Birleson, Rajendra Yadava, Mirriam Sangombe, Sam Stafford, Tom Hughes, Lucy Knibbs, Bethan Morse, Stefan Schwarz, Benjamin Jelley, Susan White, Bella Richard, Heidi Lawson, Sally Moseley, Michelle Tayler, Mandy Edwards, Claire Triscott, Rebecca Wallace, Angela Hall, Amanda Dell, Khalid Rashed, Sarah Board, Clare Buckley, Alfonso Tanate, Tressy Pitt-Kerby, Kate Beesley, Jess Perry, Christine Hellyer, Paul Guyler, Nisha Menon, Sharon Tysoe, Raji Prabakaran, Martin Cooper, Anoja Rajapakse, Inez Wynter, Susan Smith, Nic Weir, Cherish Boxall, Hannah Yates, Simon Smith, Pamela Crawford, James Marigold, Fiona Smith, Jake Harvey, Sue Evans, Laura Baldwin, Sarah Hammond, Paul Mudd, Angela Bowring, Samantha Keenan, Kevin Thorpe, Mohammad Haque, Joanne Taaffe, Natalie Temple, Tracey Peachey, Kim Wells, Fiona Haines, Nicola Butterworth-Cowin, Zoey Horne, Radim Licenik, Hayley Boughton, Timothy England, Amanda Hedstrom, Brian Menezes, Ruth Davies, Venetia Johnson, Simon Whittingham-Jones, David Werring, Sabaa Obarey, Caroline Watchurst, Amy Ashton, Shez Feerick, Nina Francia, Azra Banaras, Daniel Epstein, Marilena Marinescu, Annick Williams, Anna Robinson, Fiona Humphries, Ijaz Anwar, Arunkumar Annamalai, Susan Crawford, Vicky Collins, Lorna Shepherd, Elaine Siddle, Justin Penge, Sam Qureshi, Vinodh Krishnamurthy, Vasileios Papavasileiou, Dean Waugh, Emelda Veraque, Nathan Douglas, Numan Khan, Sankaranarayanan Ramachandran, Peter Sommerville, Anthony Rudd, Sagal Kullane, Ajay Bhalla, Jonathan Birns, Rowshanara Ahmed, Meegan Gibbons, Eva Klamerus, Benjie Cendreda, Keith Muir, Nicola Day, Angela Welch, Wilma Smith, Jennifer Elliot, Salwa Eltawil, Ammad Mahmood, Kim Hatherley, Shirley Mitchell, Harjit Bains, Lauren Quinn, Rachel Teal, Ivie Gbinigie, George Harston, Phil Mathieson, Gary Ford, Ursula Schulz, James Kennedy, Kirubananthan Nagaratnam, Kiran Bangalore, Neelima Bhupathiraju, Chris Wharton, Ken Fotherby, Ahmad Nasar, Angie Stevens, Angela Willberry, Rachel Evans, Baljinder Rai, Chloe Blake, Kamy Thavanesan, Gail Hann, Tanith Changuion, Sara Nix, Amanda Whiting, Michelle Dharmasiri, Louise Mallon, Marketa Keltos, Nigel Smyth, Charlotte Eglinton, John Duffy, Ela Tone, Lucy Sykes, Emily Porter, Carolyn Fitton, Nikolaos Kirkineziadis, Gillian Cluckie, Kate Kennedy, Sarah Trippier, Rebecca Williams, Elizabeth Hayter, James Rackie, Bhavini Patel, Ghatala Rita, Adrian Blight, Val Jones, Liqun Zhang, Lillian Choy, Anthony Pereira, Brian Clarke, Samer Al-Hussayni, Lynn Dixon, Andrew Young, Adrian Bergin, David Broughton, Senthil Raghunathan, Benjamin Jackson, Jason Appleton, Gwendoline Wilkes, Amanda Buck, Carla Richardson, Judith Clarke, Lucy Fleming, Gemma Squires, Zhe Law, Camille Hutchinson, Vera Cvoro, Mandy Couser, Amanda McGregor, Sean McAuley, Susan Pound, Patricia Cochrane, Clare Holmes, Peter Murphy, Nicola Devitt, Mairead Osborn, Amy Steele, Lucy Belle Guthrie, Elizabeth Smith, Jonathan Hewitt, Natalie Chaston, Min Myint, Andrew Smith, Louise Fairlie, Michelle Davis, Beth Atkinson, Stephen Woodward, Valerie Hogg, Michelle Fawcett, Louise Finlay, Anand Dixit, Eleanor Cameron, Breffni Keegan, Jim Kelly, Dónal Concannon, Dipankar Dutta, Deborah Ward, Jon Glass, Susan O'Connell, Joseph Ngeh, Alison O'Kelly, Emma Williams, Suzanne Ragab, Damian Jenkinson, Judith Dube, Laura Gleave, Jacqui Leggett, Nisha Kissoon, Louise Southern, Utpal Naghotra, Maria Bokhari, Beverley McClelland, Katja Adie, Abhijit Mate, Frances Harrington, Ali James, Elizabeth Swanson, Terri Chant, Miriam Naccache, Abbie Coutts, Gillian Courtauld, Sarah Whurr, Sue Webber, Emily Shead, Robert Luder, Maneesh Bhargava, Elodie Murali, Larissa Cuenoud, Kath Pasco, O Speirs, Lianne Chapman, Linda Inskip, Lisa Kavanagh, Meena Srinivasan, Nichola Motherwell, Indranil Mukherjee, Louise Tonks, Denise Donaldson, Heather Button, Rebecca Wilcox, Fran Hurford, Rachel Logan, Andy Taylor, Tracie Arden, Michael Carpenter, Prabal Datta, Tajammal Zahoor, Linda Jackson, Ann Needle, Andrew Stanners, Imran Ghouri, Donna Exley, Salman Akhtar, Hollie Brooke, Shannen Beadle, Eoin O'Brien, Jobbin Francis, Joanne McGee, Elaine Amis, Jennifer Mitchell, Sarah Finlay, Devesh Sinha, Csilla Manoczki, Sam King, James Tarka, Sumita Choudhary, Jegamalini Premaruban, Dorothy Sutton, Pradeep Kumar, Charlotte Culmsee, Caroline Winckley, Holly Davies, Hilary Thatcher, Evangelos Vasileiadis, Basaam Aweid, Melinda Holden, Cathy Mason, Thant Hlaing, Gladys Madzamba, Tanya Ingram, Michelle Linforth, Claire Cullen, Nibu Thomas, John France, Afaq Saulat, Biju Bhaskaran, Pauline Fitzell, Kathleen Horan, Catherine Manyoni, Josie Garfield-Smith, Hannah Griffin, Stacey Atkins, Joan Redome, Girish Muddegowda, Holly Maguire, Adrian Barry, Nenette Abano, Resti Varquez, Joanne Hiden, Susan Lyjko, Alda Remegoso, Kay Finney, Adrian Butler, Martin Strecker, Mary Joan MaCleod, Janice Irvine, Sandra Nelson, German Guzmangutierrez, Jacqueline Furnace, Vicky Taylor, Hawraman Ramadan, Kim Storton, Sohail Hassan, Eman Abdus Sami, Ruth Bellfield, Kelvin Stewart, Outi Quinn, Chris Patterson, Hedley Emsley, Bindu Gregary, Shakeel Ahmed, Shakeelah Patel, Sonia Raj, Sulaiman Sultan, Fiona Wright, Peter Langhorne, Ruth Graham, Terry Quinn, and Kate McArthur

Subjects
Adult, medicine.medical_specialty, Adolescent, medicine.drug_class, Population, Minimisation (clinical trials), Intracranial haemorrhage, subarachnoid haemorrhage, antiplatelet therapy, law.invention, Randomized controlled trial, law, Internal medicine, Atrial Fibrillation, Medicine, Humans, atrial fibrillation, Prospective Studies, education, Adverse effect, Stroke, oral anticoagulation, education.field_of_study, business.industry, Hazard ratio, intraventricular haemorrhage, Anticoagulants, Atrial fibrillation, intracerebral haemorrhage, Vitamin K antagonist, medicine.disease, United Kingdom, subdural haemorrhage, Neurology (clinical), business, Intracranial Hemorrhages, randomised controlled trial
Abstract

Summary Background Oral anticoagulation reduces the rate of systemic embolism for patients with atrial fibrillation by two-thirds, but its benefits for patients with previous intracranial haemorrhage are uncertain. In the Start or STop Anticoagulants Randomised Trial (SoSTART), we aimed to establish whether starting is non-inferior to avoiding oral anticoagulation for survivors of intracranial haemorrhage who have atrial fibrillation. Methods SoSTART was a prospective, randomised, open-label, assessor-masked, parallel-group, pilot phase trial done at 67 hospitals in the UK. We recruited adults (aged ≥18 years) who had survived at least 24 h after symptomatic spontaneous intracranial haemorrhage, had atrial fibrillation, and had a CHA2DS2-VASc score of at least 2. Web-based computerised randomisation incorporating a minimisation algorithm allocated participants (1:1) to start or avoid long-term (≥1 year) full treatment dose open-label oral anticoagulation. The participants assigned to start oral anticoagulation received either a direct oral anticoagulant or vitamin K antagonist, and the group assigned to avoid oral anticoagulation received standard clinical practice (antiplatelet agent or no antithrombotic agent). The primary outcome was recurrent symptomatic spontaneous intracranial haemorrhage, and was adjudicated by an individual masked to treatment allocation. All outcomes were ascertained for at least 1 year after randomisation and assessed in the intention-to-treat population of all randomly assigned participants, using Cox proportional hazards regression adjusted for minimisation covariates. We planned a sample size of 190 participants (one-sided p=0·025, power 90%, allowing for non-adherence) based on a non-inferiority margin of 12% (or adjusted hazard ratio [HR] of 3·2). This trial is registered with ClinicalTrials.gov (NCT03153150) and is complete. Findings Between March 29, 2018, and Feb 27, 2020, consent was obtained at 61 sites for 218 participants, of whom 203 were randomly assigned at a median of 115 days (IQR 49–265) after intracranial haemorrhage onset. 101 were assigned to start and 102 to avoid oral anticoagulation. Participants were followed up for median of 1·2 years (IQR 0·97–1·95; completeness 97·2%). Starting oral anticoagulation was not non-inferior to avoiding oral anticoagulation: eight (8%) of 101 in the start group versus four (4%) of 102 in the avoid group had intracranial haemorrhage recurrences (adjusted HR 2·42 [95% CI 0·72–8·09]; p=0·152). Serious adverse events occurred in 17 (17%) participants in the start group and 15 (15%) in the avoid group. 22 (22%) patients in the start group and 11 (11%) patients in the avoid group died during the study. Interpretation Whether starting oral anticoagulation was non-inferior to avoiding it for people with atrial fibrillation after intracranial haemorrhage was inconclusive, although rates of recurrent intracranial haemorrhage were lower than expected. In view of weak evidence from analyses of three composite secondary outcomes, the possibility that oral anticoagulation might be superior for preventing symptomatic major vascular events should be investigated in adequately powered randomised trials. Funding British Heart Foundation, Medical Research Council, Chest Heart & Stroke Scotland.

Published
2021
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3. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Author

Merryn Voysey, Sue Ann Costa Clemens, Shabir A Madhi, Lily Y Weckx, Pedro M Folegatti, Parvinder K Aley, Brian Angus, Vicky L Baillie, Shaun L Barnabas, Qasim E Bhorat, Sagida Bibi, Carmen Briner, Paola Cicconi, Andrea M Collins, Rachel Colin-Jones, Clare L Cutland, Thomas C Darton, Keertan Dheda, Christopher J A Duncan, Katherine R W Emary, Katie J Ewer, Lee Fairlie, Saul N Faust, Shuo Feng, Daniela M Ferreira, Adam Finn, Anna L Goodman, Catherine M Green, Christopher A Green, Paul T Heath, Catherine Hill, Helen Hill, Ian Hirsch, Susanne H C Hodgson, Alane Izu, Susan Jackson, Daniel Jenkin, Carina C D Joe, Simon Kerridge, Anthonet Koen, Gaurav Kwatra, Rajeka Lazarus, Alison M Lawrie, Alice Lelliott, Vincenzo Libri, Patrick J Lillie, Raburn Mallory, Ana V A Mendes, Eveline P Milan, Angela M Minassian, Alastair McGregor, Hazel Morrison, Yama F Mujadidi, Anusha Nana, Peter J O’Reilly, Sherman D Padayachee, Ana Pittella, Emma Plested, Katrina M Pollock, Maheshi N Ramasamy, Sarah Rhead, Alexandre V Schwarzbold, Nisha Singh, Andrew Smith, Rinn Song, Matthew D Snape, Eduardo Sprinz, Rebecca K Sutherland, Richard Tarrant, Emma C Thomson, M Estée Török, Mark Toshner, David P J Turner, Johan Vekemans, Tonya L Villafana, Marion E E Watson, Christopher J Williams, Alexander D Douglas, Adrian V S Hill, Teresa Lambe, Sarah C Gilbert, Andrew J Pollard, Marites Aban, Fatola Abayomi, Kushala Abeyskera, Jeremy Aboagye, Matthew Adam, Kirsty Adams, James Adamson, Yemi A. Adelaja, Gbadebo Adewetan, Syed Adlou, Khatija Ahmed, Yasmeen Akhalwaya, Saajida Akhalwaya, Andrew Alcock, Aabidah Ali, Elizabeth R. Allen, Lauren Allen, Thamires C. D. S. C Almeida, Mariana P.S. Alves, Fabio Amorim, Foteini Andritsou, Rachel Anslow, Matthew Appleby, Edward H. Arbe-Barnes, Mark P. Ariaans, Beatriz Arns, Laiana Arruda, Paula Azi, Lorena Azi, Gavin Babbage, Catherine Bailey, Kenneth F. Baker, Megan Baker, Natalie Baker, Philip Baker, Lisa Baldwin, Ioana Baleanu, Danieli Bandeira, Anna Bara, Marcella A.S. Barbosa, Debbie Barker, Gavin D. Barlow, Eleanor Barnes, Andrew S. Barr, Jordan R. Barrett, Jessica Barrett, Louise Bates, Alexander Batten, Kirsten Beadon, Emily Beales, Rebecca Beckley, Sandra Belij-Rammerstorfer, Jonathan Bell, Duncan Bellamy, Nancy Bellei, Sue Belton, Adam Berg, Laura Bermejo, Eleanor Berrie, Lisa Berry, Daniella Berzenyi, Amy Beveridge, Kevin R. Bewley, Helen Bexhell, Sutika Bhikha, Asad E. Bhorat, Zaheda E. Bhorat, Else Bijker, Geeta Birch, Sarah Birch, Adam Bird, Olivia Bird, Karen Bisnauthsing, Mustapha Bittaye, Katherine Blackstone, Luke Blackwell, Heather Bletchly, Caitlin L. Blundell, Susannah R. Blundell, Pritesh Bodalia, Bruno C. Boettger, Emma Bolam, Elena Boland, Daan Bormans, Nicola Borthwick, Francesca Bowring, Amy Boyd, Penny Bradley, Tanja Brenner, Phillip Brown, Claire Brown, Charlie Brown-O'Sullivan, Scott Bruce, Emily Brunt, Ruaridh Buchan, William Budd, Yusuf A. Bulbulia, Melanie Bull, Jamie Burbage, Hassan Burhan, Aileen Burn, Karen R. Buttigieg, Nicholas Byard, Ingrid Cabera Puig, Gloria Calderon, Anna Calvert, Susana Camara, Michelangelo Cao, Federica Cappuccini, João R. Cardoso, Melanie Carr, Miles W. Carroll, Andrew Carson-Stevens, Yasmin de M. Carvalho, José A.M. Carvalho, Helen R. Casey, Paul Cashen, Thais Castro, Lucia Carratala Castro, Katrina Cathie, Ana Cavey, José Cerbino-Neto, Jim Chadwick, David Chapman, Sue Charlton, Irina Chelysheva, Oliver Chester, Sunder Chita, Jee-Sun Cho, Liliana Cifuentes, Elizabeth Clark, Matthew Clark, Andrea Clarke, Elizabeth A. Clutterbuck, Sarah L.K. Collins, Christopher P. Conlon, Sean Connarty, Naomi Coombes, Cushla Cooper, Rachel Cooper, Lynne Cornelissen, Tumena Corrah, Catherine Cosgrove, Tony Cox, Wendy E.M. Crocker, Sarah Crosbie, Lorraine Cullen, Dan Cullen, Debora R.M.F. Cunha, Christina Cunningham, Fiona C. Cuthbertson, Suzete N. Farias Da Guarda, Larissa P. da Silva, Brad E. Damratoski, Zsofia Danos, Maria T.D.C. Dantas, Paula Darroch, Mehreen S. Datoo, Chandrabali Datta, Malika Davids, Sarah L. Davies, Hannah Davies, Elizabeth Davis, Judith Davis, John Davis, Maristela M.D. De Nobrega, Lis Moreno De Oliveira Kalid, David Dearlove, Tesfaye Demissie, Amisha Desai, Stefania Di Marco, Claudio Di Maso, Maria I.S. Dinelli, Tanya Dinesh, Claire Docksey, Christina Dold, Tao Dong, Francesca R. Donnellan, Tannyth Dos Santos, Thainá G. dos Santos, Erika Pachecho Dos Santos, Naomi Douglas, Charlotte Downing, Jonathan Drake, Rachael Drake-Brockman, Kimberley Driver, Ruth Drury, Susanna J. Dunachie, Benjamin S. Durham, Lidiana Dutra, Nicholas J.W. Easom, Samual van Eck, Mandy Edwards, Nick J. Edwards, Omar M. El Muhanna, Sean C. Elias, Mike Elmore, Marcus English, Alisgair Esmail, Yakub Moosa Essack, Eoghan Farmer, Mutjaba Farooq, Madi Farrar, Leonard Farrugia, Beverley Faulkner, Sofiya Fedosyuk, Sally Felle, Carla Ferreira Da Silva, Samantha Field, Richard Fisher, Amy Flaxman, James Fletcher, Hazel Fofie, Henry Fok, Karen J. Ford, Jamie Fowler, Pedro H.A. Fraiman, Emma Francis, Marilia M. Franco, John Frater, Marilúcia S.M. Freire, Samantha H. Fry, Sabrina Fudge, Julie Furze, Michelle Fuskova, Pablo Galian-Rubio, Eva Galiza, Harriet Garlant, Madita Gavrila, Ailsa Geddes, Karyna A. Gibbons, Ciaran Gilbride, Hardeep Gill, Sharon Glynn, Kerry Godwin, Karishma Gokani, Ursula Carvalho Goldoni, Maria Goncalves, Isabela G.S. Gonzalez, Jayne Goodwin, Amina Goondiwala, Katherine Gordon-Quayle, Giacomo Gorini, Janet Grab, Lara Gracie, Melanie Greenland, Nicola Greenwood, Johann Greffrath, Marisa M. Groenewald, Leonardo Grossi, Gaurav Gupta, Mark Hackett, Bassam Hallis, Mainga Hamaluba, Elizabeth Hamilton, Joseph Hamlyn, Daniel Hammersley, Aidan T. Hanrath, Brama Hanumunthadu, Stephanie A. Harris, Clair Harris, Tara Harris, Thomas D. Harrison, Daisy Harrison, Thomas C. Hart, Birgit Hartnell, Shadin Hassan, John Haughney, Sophia Hawkins, Jodie Hay, Ian Head, John Henry, Macarena Hermosin Herrera, David B. Hettle, Jennifer Hill, Gina Hodges, Elizea Horne, Mimi M. Hou, Catherine Houlihan, Elizabeth Howe, Nicola Howell, Jonathan Humphreys, Holly E. Humphries, Katrina Hurley, Claire Huson, Angela Hyder-Wright, Catherine Hyams, Sabina Ikram, Alka Ishwarbhai, Monica Ivan, Poppy Iveson, Vidyashankara Iyer, Frederic Jackson, Jeanne De Jager, Shameem Jaumdally, Helen Jeffers, Natasha Jesudason, Bryony Jones, Kathryn Jones, Elizabeth Jones, Christopher Jones, Marianna Rocha Jorge, Aylin Jose, Amar Joshi, Eduardo A.M.S. Júnior, Joanne Kadziola, Reshma Kailath, Faeeza Kana, Konstantinos Karampatsas, Mwila Kasanyinga, Jade Keen, Elizabeth J. Kelly, Dearbhla M. Kelly, Debbie Kelly, Sarah Kelly, David Kerr, Renato de Ávila Kfouri, Liaquat Khan, Baktash Khozoee, Sarah Kidd, Annabel Killen, Jasmin Kinch, Patrick Kinch, Lloyd D.W. King, Thomas B. King, Lucy Kingham, Paul Klenerman, Francesca Knapper, Julian C. Knight, Daniel Knott, Stanislava Koleva, Matilda Lang, Gail Lang, Colin W. Larkworthy, Jessica P.J. Larwood, Rebecca Law, Erica M. Lazarus, Amanda Leach, Emily A. Lees, Nana-Marie Lemm, Alvaro Lessa, Stephanie Leung, Yuanyuan Li, Amelia M. Lias, Kostas Liatsikos, Aline Linder, Samuel Lipworth, Shuchang Liu, Xinxue Liu, Adam Lloyd, Stephanie Lloyd, Lisa Loew, Raquel Lopez Ramon, Leandro Lora, Vicki Lowthorpe, Kleber Luz, Jonathan C. MacDonald, Gordon MacGregor, Meera Madhavan, David O. Mainwaring, Edson Makambwa, Rebecca Makinson, Mookho Malahleha, Ross Malamatsho, Garry Mallett, Kushal Mansatta, Takalani Maoko, Katlego Mapetla, Natalie G. Marchevsky, Spyridoula Marinou, Emma Marlow, Gabriela N. Marques, Paula Marriott, Richard P. Marshall, Julia L. Marshall, Flávia J. Martins, Masebole Masenya, Mduduzi Masilela, Shauna K. Masters, Moncy Mathew, Hosea Matlebjane, Kedidimetse Matshidiso, Olga Mazur, Andrea Mazzella, Hugh McCaughan, Joanne McEwan, Joanna McGlashan, Lorna McInroy, Zoe McIntyre, Daniela McLenaghan, Nicky McRobert, Steve McSwiggan, Clare Megson, Savviz Mehdipour, Wilma Meijs, Renata N.Á. Mendonça, Alexander J. Mentzer, Neginsadat Mirtorabi, Celia Mitton, Sibusiso Mnyakeni, Fiona Moghaddas, Kgaogelo Molapo, Mapule Moloi, Maria Moore, M. Isabel Moraes-Pinto, Marni Moran, Ella Morey, Róisín Morgans, Susan Morris, Sheila Morris, Helen C. Morris, Franca Morselli, Gertraud Morshead, Richard Morter, Lynelle Mottal, Andrew Moultrie, Nathifa Moya, Mushiya Mpelembue, Sibekezelo Msomi, Yvonne Mugodi, Ekta Mukhopadhyay, Jilly Muller, Alasdair Munro, Claire Munro, Sarah Murphy, Philomena Mweu, Celia Hatsuko Myasaki, Gurudutt Naik, Kush Naker, Eleni Nastouli, Abida Nazir, Bongani Ndlovu, Fabio Neffa, Cecilia Njenga, Helena Noal, Andrés Noé, Gabrielle Novaes, Fay L. Nugent, Géssika Nunes, Katie O'Brien, Daniel O'Connor, Miranda Odam, Suzette Oelofse, Blanche Oguti, Victoria Olchawski, Neil J. Oldfield, Marianne G. Oliveira, Catarina Oliveira, Angela Oosthuizen, Paula O'Reilly, Piper Osborne, David R.J. Owen, Lydia Owen, Daniel Owens, Nelly Owino, Mihaela Pacurar, Brenda V.B. Paiva, Edna M.F. Palhares, Susan Palmer, Sivapriyai Parkinson, Helena M.R.T. Parracho, Karen Parsons, Dipak Patel, Bhumika Patel, Faeezah Patel, Kelly Patel, Maia Patrick-Smith, Ruth O. Payne, Yanchun Peng, Elizabeth J. Penn, Anna Pennington, Marco Polo Peralta Alvarez, James Perring, Nicola Perry, Rubeshan Perumal, Sahir Petkar, Tricia Philip, Daniel J. Phillips, Jennifer Phillips, Mary Kgomotso Phohu, Lorinda Pickup, Sonja Pieterse, Jo Piper, Dimitra Pipini, Mary Plank, Joan Du Plessis, Samuel Pollard, Jennifer Pooley, Anil Pooran, Ian Poulton, Claire Powers, Fernando B. Presa, David A. Price, Vivien Price, Marcelo Primeira, Pamela C. Proud, Samuel Provstgaard-Morys, Sophie Pueschel, David Pulido, Sheena Quaid, Ria Rabara, Alexandra Radford, Kajal Radia, Durga Rajapaska, Thurkka Rajeswaran, Alberto San Francisco Ramos, Fernando Ramos Lopez, Tommy Rampling, Jade Rand, Helen Ratcliffe, Tom Rawlinson, David Rea, Byron Rees, Jesús Reiné, Mila Resuello-Dauti, Emilia Reyes Pabon, Carla M. Ribiero, Marivic Ricamara, Alex Richter, Neil Ritchie, Adam J. Ritchie, Alexander J. Robbins, Hannah Roberts, Ryan E. Robinson, Hannah Robinson, Talita T. Rocchetti, Beatriz Pinho Rocha, Sophie Roche, Christine Rollier, Louisa Rose, Amy L. Ross Russell, Lindie Rossouw, Simon Royal, Indra Rudiansyah, Sarah Ruiz, Stephen Saich, Claudia Sala, Jessica Sale, Ahmed M. Salman, Natalia Salvador, Stephannie Salvador, Milla Sampaio, Annette D. Samson, Amada Sanchez-Gonzalez, Helen Sanders, Katherine Sanders, Erika Santos, Mayara F.S. Santos Guerra, Iman Satti, Jack E. Saunders, Caroline Saunders, Aakifah Sayed, Ina Schim van der Loeff, Annina B. Schmid, Ella Schofield, Gavin Screaton, Samiullah Seddiqi, Rameswara R. Segireddy, Roberta Senger, Sonia Serrano, Rajiv Shah, Imam Shaik, Hannah E. Sharpe, Katherine Sharrocks, Robert Shaw, Adam Shea, Amy Shepherd, James G. Shepherd, Farah Shiham, Emad Sidhom, Sarah E. Silk, Antonio Carlos da Silva Moraes, Gilberto Silva-Junior, Laura Silva-Reyes, Anderson D. Silveira, Mariana B.V. Silveira, Jaisi Sinha, Donal T. Skelly, Daniel C. Smith, Nick Smith, Holly E. Smith, David J. Smith, Catherine C. Smith, Airanuédida Soares, Tiago Soares, Carla Solórzano, Guilherme L. Sorio, Kim Sorley, Tiffany Sosa-Rodriguez, Cinthia M.C.D.L. Souza, Bruno S.D.F. Souza, Alessandra R. Souza, Alexandra J. Spencer, Fernanda Spina, Louise Spoors, Lizzie Stafford, Imogen Stamford, Igor Starinskij, Ricardo Stein, Jill Steven, Lisa Stockdale, Lisa V. Stockwell, Louise H. Strickland, Arabella C. Stuart, Ann Sturdy, Natalina Sutton, Anna Szigeti, Abdessamad Tahiri-Alaoui, Rachel Tanner, Carol Taoushanis, Alexander W. Tarr, Keja Taylor, Ursula Taylor, Iona Jennifer Taylor, Justin Taylor, Rebecca te Water Naude, Yrene Themistocleous, Andreas Themistocleous, Merin Thomas, Kelly Thomas, Tonia M. Thomas, Asha Thombrayil, Fawziyah Thompson, Amber Thompson, Kevin Thompson, Ameeka Thompson, Julia Thomson, Viv Thornton-Jones, Patrick J. Tighe, Lygia Accioly Tinoco, Gerlynn Tiongson, Bonolo Tladinyane, Michele Tomasicchio, Adriana Tomic, Susan Tonks, James Towner, Nguyen Tran, Julia Tree, Gerry Trillana, Charlotte Trinham, Rose Trivett, Adam Truby, Betty Lebogang Tsheko, Aadil Turabi, Richard Turner, Cheryl Turner, Marta Ulaszewska, Benjamin R. Underwood, Rachel Varughese, Dennis Verbart, Marije Verheul, Iason Vichos, Taiane Vieira, Claire S. Waddington, Laura Walker, Erica Wallis, Matthew Wand, Deborah Warbick, Theresa Wardell, George Warimwe, Sarah C. Warren, Bridget Watkins, Ekaterina Watson, Stewart Webb, Alice Webb-Bridges, Angela Webster, Jessica Welch, Jeanette Wells, Alison West, Caroline White, Rachel White, Paul Williams, Rachel L. Williams, Rebecca Winslow, Mark Woodyer, Andrew T. Worth, Danny Wright, Marzena Wroblewska, Andy Yao, Rafael Zimmer, Dalila Zizi, Peter Zuidewind, Group, Oxford COVID Vaccine Trial, Toshner, Mark [0000-0002-3969-6143], and Apollo - University of Cambridge Repository

Subjects
Male, COVID-19/prevention & control, 030204 cardiovascular system & hematology, law.invention, South Africa, 0302 clinical medicine, Randomized controlled trial, law, Oxford COVID Vaccine Trial Group, wc_505, Single-Blind Method, 030212 general & internal medicine, Young adult, 11 Medical and Health Sciences, wa_105, Covid19, General Medicine, Articles, Middle Aged, Treatment Outcome, Cohort, Perspective, Female, Brazil, Adult, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, qw_806, qw_805, 03 medical and health sciences, Young Adult, Double-Blind Method, Conjugate vaccine, Internal medicine, General & Internal Medicine, ChAdOx1 nCoV-19, medicine, Humans, Adverse effect, Aged, business.industry, SARS-CoV-2, COVID-19, Viral Vaccines, Vaccine efficacy, Interim analysis, United Kingdom, Clinical trial, bf023de6, business, COVID-19 Vaccines/adverse effects
Abstract

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. \ud \ud \ud METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. \ud \ud \ud FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. \ud \ud \ud INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. \ud \ud \ud FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.

Published
2020
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