Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS), also known as multisystem inflammatory syndrome in children (MIS-C) emerged in April, 2020. The paediatric comparisons within the RECOVERY trial aimed to assess the effect of intravenous immunoglobulin or corticosteroids compared with usual care on duration of hospital stay for children with PIMS-TS and to compare tocilizumab (anti-IL-6 receptor monoclonal antibody) or anakinra (anti-IL-1 receptor antagonist) with usual care for those with inflammation refractory to initial treatment. METHODS: We did this randomised, controlled, open-label, platform trial in 51 hospitals in the UK. Eligible patients were younger than 18 years and had been admitted to hospital for PIMS-TS. In the first randomisation, patients were randomly assigned (1:1:1) to usual care (no additional treatments), usual care plus methylprednisolone (10mg/kg per day for 3 consecutive days), or usual care plus intravenous immunoglobulin (a single dose of 2 g/kg). If further anti-inflammatory treatment was considered necessary, children aged at least 1 year could be considered for a second randomisation, in which patients were randomly assigned (1:2:2) to usual care, intravenous tocilizumab (12 mg/kg in patients <30 kg; 8mg/kg in patients ≥30 kg, up to a maximum dose of 800 mg), or subcutaneous anakinra (2 mg/kg once per day in patients ≥10 kg). Randomisation was by use of a web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was duration of hospital stay. Analysis was by intention to treat. For treatments assessed in each randomisation, a single Bayesian framework assuming uninformative priors for treatment was used to jointly assess the efficacy of each intervention compared with usual care. The trial was registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). FINDINGS: Between May 18, 2020, and Jan 20, 2022, 237 children with PIMS-TS were enrolled and included in the intention-to-treat analysis. Of the 214 patients who entered the first randomisation, 73 were assigned to receive intravenous immunoglobulin, 61 methylprednisolone, and 80 usual care. Of the 70 children who entered the second randomisation (including 23 who did not enter the first randomisation), 28 were assigned to receive tocilizumab, 14 anakinra, and 28 usual care. Mean age was 9·5 years (SD 3·8) in the randomisation and 9·6 years (3·6) in the second randomisation. 118 (55%) of 214 patients in the first randomisation and 39 (56%) of 70 patients in the second randomisation were male. 130 (55%) of 237 patients were Black, Asian, or minority ethnic, and 105 (44%) were White. Mean duration of hospital stay was 7·4 days (SD 0·4) in children assigned to intravenous immunoglobulin and 7·6 days (0·4) in children assigned to usual care (difference -0·1 days, 95% credible interval [CrI] -1·3 to 1·0; posterior probability 59%). Mean duration of hospital stay was 6·9 days (SD 0·5) in children assigned to methylprednisolone (difference from usual care -0·7 days, 95% CrI -1·9 to 0·6; posterior probability 87%). Mean duration of hospital stay was 6·6 days (SD 0·7) in children assigned to second-line tocilizumab and 9·9 days (0·9) in children assigned to usual care (difference -3·3 days, 95% CrI -5·6 to -1·0; posterior probability >99%). Mean duration of hospital stay was 8·5 days (SD 1·2) in children assigned to anakinra (difference from usual care -1·4 days, 95% CrI -4·3 to 1·8; posterior probability 84%). Two persistent coronary artery aneurysms were reported among patients assigned to usual care in the first randomisation. There were few cardiac arrythmias, bleeding, or thrombotic events in any group. Two children died; neither was considered related to study treatment. INTERPRETATION: Moderate evidence suggests that, compared with usual care, first-line intravenous methylprednisolone reduces duration of hospital stay for children with PIMS-TS. Good evidence suggests that second-line tocilizumab reduces duration of hospital stay for children with inflammation refractory to initial treatment. Neither intravenous immunoglobulin nor anakinra had any effect on duration of hospital stay compared with usual care. FUNDING: Medical Research Council and National Institute of Health Research.
Authors: Saul N Faust, Richard Haynes, Christine E Jones, Natalie Staplin, Elizabeth Whittaker, Thomas Jaki, Ed Juszczak, Enti Spata, Mandy Wan, Alasdair Bamford, Paul Dimitri, Adam Finn, John Furness, Athimalaipet V Ramanan, Christopher Gale, Katrina Cathie, Simon Drysdale, Jolanta Bernatoniene, Clare Murray, Charles C Roehr, Paul Fleming, Andrew Riordan, Srini Bandi, Deepthi Jyothish, Jennifer Evans, Marieke Emonts, Dominic Kelly, Nazima Pathan, Patrick Davies, Rosie Hague, Louisa Pollock, Malcolm G Semple, Leon Peto, J Kenneth Baillie, Maya Buch, Katie Jeffery, Marian Knight, Wei Shen Lim, Alan Montgomery, Aparna Mukherjee, Andrew Mumford, Kathryn Rowan, Guy Thwaites, Marion Mafham, Jonathan Emberson, Martin J Landray, Peter W Horby, Lucy Chappell, Jeremy Day, DV Dung, Jeremy Day, NN Quang, Prof Binh, E Burhan, B Alisjahbana, J Koirala, S Basnet, E Kestelyn, B Basnyat, P Gyanwali, RL Hamers, P Sandercock, J Darbyshire, D DeMets, R Fowler, D Lalloo, M Munavvar, I Roberts, A Warris, J Wittes, A Craddock-Bamford, J Barton, A Basoglu, R Brown, W Brudlo, E Denis, L Fletcher, S Howard, S Musini, K Taylor, G Cui, B Goodenough, A King, M Lay, D Murray, W Stevens, K Wallendszus, R Welsh, C Crichton, J Davies, R Goldacre, C Harper, F Knight, M Nunn, H Salih, J Welch, M Campbell, G Pessoa-Amorim, M Zayed, J Wiles, G Bagley, S Cameron, S Chamberlain, B Farrell, H Freeman, A Kennedy, A Whitehouse, S Wilkinson, C Wood, C Reith, K Davies, H Halls, L Holland, R Truell, K Wilson, Emma Lingwood, L Howie, M Lunn, Penelope Rodgers, J Amuasi, K Baird, T Bao, B Basnyat, M Bittaye, J Bonney, U D'Alessandro, M Dhimal, P Gyanwali, RL Hamers, T Huyen, A Jagne, A Karkey, E Kestelyn, O Maiga, E Matey, B Nadjm, J Nel, S Pant, K Puspatriani, M Rahardjani, S Raijal, H Rees, A Rimainar, C Roberts, A Rocca, S Shrestha, E Usuf, C Vidaillic, F Wulandari, A Alexander, M Amezaga, C Armah, A Asghar, P Aubrey, K Barker-Williams, A Barnard, J Bartholomew, D Beaumont-Jewell, S Beddows, J Beety, C Birch, P Boyle, M Brend, M Brookes, C Callens, D Campbell, H Campbell, H Cate, E Chambers, K Chapman, A Coe, J Collins, S Crawshaw, S Das, A De Soyza, E Denton, P Dicks, M Dolman, K Donaldson, L Dowden, S Dowling, C Drake, H Duckles-Leech, H Duffy, L Gerdes, K Gibbons, L Gill, K Gilmour, J Goodwin, J Graham, C Green, C Hall, A Hall, K Hampshire, J Hanson, T Harman, H Harper, S Harrison, J Hicks, H Hodgson, M Hough, S Jackson, G Johnson, J Kirk, N Lemoine, C Levett, S Lock, T Lockett, M Logan, K Lomme, J Luo, N McMillan, H Membrey, N Mguni, J Minton, H Monaghan, S Murphy, N Muzengi, M Naz, I Nickson, M Odam, U Ohia, E Okell, A Oliver, K Pearson, K Pine, R Pleass, D Porter, L Porter, A Potter, V Poustie, S Pratt, A Price, A Priest, A Rodgers, C Rook, P Ryan, S Sam, P Sharratt, J Sheffield, J Shenton, K Shirley, T Skinner, H Slade, M Sutu, J Taylor, E Thomas, H Tinkler, A Unsworth, R Usher, W van't Hoff, S Walker, J Walters, E Walton, J Warmington, E Wayman, P Williams, J Williamson, D Williamson, F Yelnoorkar, M Knight, K Hodson, S Pavord, C Williamson, L Bowman, F Chen, R Clarke, M Goonasekara, W Herrington, P Judge, S Ng, D Preiss, C Reith, E Sammons, D Zhu, C Arkley, P Bowker, J Bruce, V Byrne-Watts, G Chapman, G Coleman, T Denwood, J Gray, D Harrison, N Mather, H Pinches, A Rees, S Rees, G Turner, O Abani, A Abbas, F Abbas, J Abbas, K Abbas, M Abbas, 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 Aboaba, A Aboagye-Odei, 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, H Abu, A Abu-Arafeh, S Abubacker, A Abung, Y Abusamra, Y Aceampong, A Achara, D Acharya, S Acheampong, P Acheampong, J 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R Jeffrey, N Jeffreys, B Jeffs, C Jeffs, J Jeganathan Ponraj, D Jegede, T Jemima, I Jenkin, S Jenkin, A Jenkins, C Jenkins, D Jenkins, E Jenkins, I Jenkins, P Jenkins, S Jenkins, F Jennings, J Jennings, L Jennings, V Jennings, E Jerome, D Jerry, G Jervis, E Jessup-Dunton, J Jesus Silva, C Jetha, K Jethwa, S Jhanji, K Jian, Z Jiao, L Jimenez, A Jimenez Gil, J Jith, T Joefield, S Johal, N Johal, K Johannessen, A Johari, A John, M John, N John, E Johns, M Johns, A Johnson, E Johnson, K Johnson, L Johnson, M Johnson, N Johnson, O Johnson, R Johnson, B Johnston, C Johnston, J Johnston, S Johnston, V Johnston, D Johnstone, E Johnstone, J Johnstone, M Joishy, S Jone, A Jones, B Jones, C Jones, D Jones, E Jones, G Jones, J Jones, K Jones, L Jones, M Jones, N Jones, N Jones, O Jones, P Jones, R Jones, R E Jones, S Jones, T Jones, R Jonnalagadda, R Jordache, M Jordan, S Jordan, A Jose, L Jose, S Jose, A Joseph, G Joseph, P Joseph, R Joseph, S Joseph, D Joshi, P Joshi, T Joshi, M Joshi, B Josiah, L Joy, T Joyce, H Ju, A Ju Wen Kwek, A Judd, E Jude, J Juhl, S Jujjavarapu, M Juniper, K Kabiru Dawa, M Kacar, N Kadam, N Kader, A Kailey, M Kain, G Kakoullis, R Kalayi, A KalBhushan, R Kaliannan Periyasami, E Kallistrou, T Kalmus Eliasz, S Kalsoom, E Kam, J Kamara, A Kamath, P Kamath, R Kamath, S Kamerkar, N Kametas, M Kamfose, C Kamundi, D Kanabar, L Kane, O Kankam, T Kannan, A Kant, V Kapil, R Kapoor, S Kapoor, S Kaprapina, S Kar, J Kara, E Karbasi, S Karelia, R Kark, S Karmali, V Karunanithi, N Karunaratne, N Kasianczuk, A Kasiappan Balasubramanian, V Kasipandian, R Kassam, J Kathirgamachelvam, V Katsande, K Kaul, D Kaur, J Kaur, S Kaur, Z Kausar, L Kavanagh, S Kavanagh, M Kawser, A Kay, J Kay, R Kay, S Kay, J Kayappurathu, C Kaye, A Kazeem, M Ke, T Keady, R Kearns, N Kearsley, J Keating, L Keating, E Keddie-Gray, B Keegan, R Keen, N Keenan, J Kefas, S Kegg, L Keith, U Keke, J Kellett, J Kelliher, A Kelly, E Kelly, H Kelly, L Kelly, M Kelly, R Kelly, S Kelly, M Kelly-Baxter, O 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Mohamed, A Mohammad, W Mohammad, A Mohammed, O Mohammed, Y Mohammed, B Mohamud, A Moharram, H-P Mok, J Mok, L Mokogwu, M Molina, C Moller-Christensen, M Mollet, M Molloholli, A Molloy, L Molloy, A Molyneux, R Molyneux, T Momoniat, K Monaghan, S Mongolu, K Monsell, M Montasser, H Montgomery, P Moodley, M Moody, N Moody, A Moon, J Moon, M Moon, M Moonan, P Moondi, S Moorby, J Moorcroft, A Moore, C Moore, D Moore, F Moore, J Moore, L Moore, N Moore, S Moore, V Moore, R Moores, E Morab, J Morales, N Moramorell, L Moran, G Moray, J Moreno-Cuest, A Morgan, C Morgan, H Morgan, K Morgan, L Morgan, M Morgan, P Morgan, K Morgan-Jones, E Morgan-Smith, J Morilla, A Morley, T Morley, W Morley, A Morris, D Morris, F Morris, H Morris, J Morris, K Morris, L Morris, M Morris, N Morris, P Morris, S Morris, D Morrison, M Morrison, S Morrison, M Morrissey, A Morrow, F Morselli, G Mortem, V Mortland, C Morton, G Morton, P Morzaria, D Mosby, L Moseley, K Moshal, B Moshy, A Moss, C Moss, J Moss, S Moss, O Mostafa, G Moth, N Motherwell, S Mottershaw, G Mouce, H Moudgil, J Mouland, C Moulds, H Moulton, E Mousley, C Mowatt, K Moxham, B Moya, Q Moyo, E Mshengu, S Mtuwa, I Muazzam, N Muchenje, D Mudawi, G Muddegowda, R Mufti, I Mugal, A Mughal, J Muglu, F Muhammad, J Muhammad, C Muir, D Mukherjee, J Mukhtar, S Mukhtar, D Mukimbiri, J Mulcahy, M Mulcahy, P Mulgrew, B Mulhearn, A Mulla, D Mullan, D Mullasseril Kutten, N Mulle, R Mullett, C Mulligan, S Mulligan, L Mumelj, H Munby, H Munday, A Munro, S Munt, M Mupudzi, A Murad, O Muraina, K Muralidhara, M Murdoch, J Murira, A Murphy, B Murphy, C Murphy, E Murphy, G Murphy, H Murphy, P Murphy, R Murphy, S Murphy, D Murray, E Murray, K Murray, L Murray, T Murray, E Murtagh, M Murthy, C Murton, R Murton, N Muru, R Musanhu, M Mushabe, O Mushtaq, A Mustafa, E Mustafa, M Mustafa, I Mustapha, N Mustfa, Z Mustufvi, C Mutch, R Mutch, E Mutema, B Muthukrishnan, S Mutton, M Mwadeyi, B Mwale, E Mwaura, R Myagerimath, A Myers, S Myers, J Myerson, K Myint, Y Myint, G Mynott, L Myslivecek, Z N Oo, P Nabayego, E Nadar, I Nadeem, M Nadheem, B Nadjm, A Naeem, H Naeem, S Naeem, S Nafees, M Nafei, T Nagarajan, L Naglik, I Nagra, D Nagra, M Naguib, K Naguleswaran, K Nagumantry, K Naicker, S Naidoo, D Nair, G Naik, R Naik, S Naik, T Nair, J Naisbitt, K Naismith, D Nakiboneka-Ssenabulya, S Nallapareddy, S Nallapeta, A Nallasivan, U Nand, A Nandani, T Nandwani, A Naqvi, S Naqvi, S Nasa, D Nash, N Nasheed, A Nasimudeen, U Nasir, T Nasser, A Natarajan, G Natarajan, N Natarajan, R Natarajan, P Nath, N Nathaniel, M Nathvani, P Nathwani, G Nava, N Navaneetham, J Navaratnam, H Navarra, S Naveed, J Navin, K Nawaz, S Nawaz, B Nayar, S Naylor, M Nayyar, F Naz, B Nazari, A Nazir, S Nazir, D Ncomanzi, O Ndefo, N Ndoumbe, A Neal, E Neary, M Negmeldin, L Nei, J Neil, P Neill, H Neils, A Nejad, A Nelson, B Nelson, L Nelson, M Nelson, R Nelson, S Nelson, R Nemane, S Nepal, D Nethercott, K Netherton, K Nettleton, A Newby, D Newby, T Newcombe, H Newell, C Newman, D Newman, H Newman, J Newman, O Newman, T Newman, R Newport, M Newton, A Ng, H Ng, K Ng, M Ng, W Ng, Y Ng, T Ngan, G Ngui, S Ngumo, Q Nguyen, K Ngwenya, C Nic Fhogartaigh, N Nicholas, P Nicholas, R Nicholas, D Nicholls, L Nicholls, S Nicholls, A Nicholson, E Nicol, R Nicol, P Nicola, A Nicoll, T Nightingale, F Nikita, P Nikolaos, G Nikonovich, A Nilsson, K Nimako, L Nimako, C Nimmo, P Ninan, M Nirmalan, A Nisar, M Nisar, T Nisar, T Nisbett, A Nisha James, S Nishat, T Nishiyama, S Nix, J Nixon, M Nixon, K Nizam Ud Din, M Nizami, S Nizamis, R Njafuh, I Noakes, L Noba, H Noble, J Noble, H Noe, J Nolan, J Nolasco, Z Noor, Z Noori, J Norcliffe, L Norman, R Norman, E Norris, K Norris, L Norris, J Nort e
Institutions: University of Regensburg, University of Nottingham, University of Oxford, King's College London, Guy's and St Thomas' NHS Foundation Trust, Evelina London Children's Healthcare, Great Ormond Street Hospital for Children NHS Foundation Trust, University College London, Sheffield Children's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Hospital for Children, University of Bristol, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Chelsea and Westminster Hospital, Imperial College London, University Hospital Southampton NHS Foundation Trust, NIHR Southampton Biomedical Research Centre, University of Southampton, St George's, University of London, University Hospitals Bristol and Weston NHS Foundation Trust, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, North Bristol NHS Trust, Southmead Hospital, Queen Mary University of London, Blizard Institute, Alder Hey Children's Hospital, University Hospitals of Leicester NHS Trust, Birmingham Women’s and Children’s NHS Foundation Trust, MRC Population Health Research Unit
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,780
Funders: Bill and Melinda Gates Foundation, Eli Lilly and Company, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Gilead Sciences, Chiesi Farmaceutici, Wellcome Trust, Health Research Board, University Hospital Southampton NHS Foundation Trust, UK Research and Innovation, Novavax, Moderna, National Institute for Health and Care Research, British Heart Foundation, Department of Health and Social Care, Imperial College London, Imperial College Healthcare NHS Trust, University of Oxford, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Public Health England, Department for International Development, Newcastle upon Tyne Hospitals NHS Foundation Trust, Swedish Orphan Biovitrum, Medical Research Council, NIHR Oxford Biomedical Research Centre, Health Data Research UK
Awards: G120503279, Maternal and perinatal outcomes of pandemic influenza in pregnancy, G2055608351, NIHR Senior Investigator Award, G2574353342, G2763620747, NIHR Senior Investigator Award, PRIME-RESTART: Promoting Recruitment using Information Management Efficiently (PRIME) for randomised controlled trials of secondary prevention after stroke, piloted using the REstart or STop Antithrombotics Randomised Trial (RESTART), G3907262765, G3915638553, G4289882605, G4345404560, Cavernomas A Randomised Effectiveness (CARE) pilot trial, to address the effectiveness of active treatment (with neurosurgery or stereotactic radiosurgery) versus conservative management in people with symptomatic brain cavernoma, G4765384873, G4776308184, G5316515788, Start or STop Anticoagulants Randomised Trial (SoSTART) for atrial fibrillation after intracranial haemorrhage: safety phase, G5900690041, G591118369, REstart or STop Antiplatelets Randomised Trial (RESTART), The clinical and cost-effectiveness of contemporary diagnostics for patients with suspected Hospital-Acquired Pneumonia (HAP)., Accelerated development of Cavernomas: A Randomised Efficacy PREcision medicine Platform trial (CARE PREP), G7273686968, G7419339253, G822820126, G8381483046, G8415457339, G8890405749, G8961892745
OpenAlex ID: W4391092522