Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO):a randomised controlled trial Article Swipe

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Wesley H. Self , Uriel Sandkovsky , Cavan Reilly , David M. Vock , Robert Gottlieb , M. Mack , Kevin Golden , Emma Dishner , Andrew M. Vekstein , Emily R. Ko , Tatyana Der , John Franzone , Eyad Almasri , Mohamed Fayed , Michael R. Filbin , Kathryn A. Hibbert , Todd W. Rice , Jonathan D. Casey , J.W. Awori Hayanga , Vinay Badhwar , Bradley G. Leshnower , Milad Sharifpour , Kirk U. Knowlton , Ithan D. Peltan , Elizieta Bakowska , Justyna Kowalska , Michael E. Bowdish , Jeffrey M. Sturek , Angela J. Rogers , D. Clark Files , Jarrod Mosier , Michelle N. Gong , David J. Douin , R. Duncan Hite , Barbara W. Trautner , Mamta K. Jain , Edward M. Gardner , Akram Khan , Jens‐Ulrik Stæhr Jensen , Michael A. Matthay , Adit A. Ginde , Samuel M. Brown , Elizabeth S. Higgs , Sarah Pett , Amy Weintrob , Christina C. Chang , Daniel D. Murrary , Huldrych F. Günthard , Ellen Moquete , Greg Grandits , Nicole Engen , Birgit Grund , Shweta Sharma , Huyen Cao , Rajesh Gupta , Suzette Y. Osei , David M. Margolis , Qing Zhu , Mark N. Polizzotto , Abdel G. Babiker , Victoria J. Davey , Virginia L. Kan , Bruce Thompson , Annetine C. Gelijns , James D. Neaton , H. Clifford Lane , Jens D. Jundgren , John Tierney , Kevin Barrett , Betsey Herpin , Mary Smolskis , Susan E. Voge , Laura A. McNay , Kelly Cahill , Page Crew , Matthew Kirchoff , Ratna Sardana , Sharon Segal Raim , Joseph Chiu , Lisa E. Hensley , J. A. Lorenzo , Rebecca Mock , Kathryn Shaw‐Saliba , Judith Zuckerman , Stacey J. Adam , Judy Currier , Sarah Read , Eric Hughes , Laura Amos , Amy Carlsen , Anita Carter , Bionca Davis , Eileen Denning , Alain DuChêne , Merrie Harrison , Payton Kaiser , Joseph S. Koopmeiners , Sue Meger , Thomas A. Murray , Kien Quan ·

YOU? · · 2022 · Open Access ·

BackgroundWe aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.MethodsIn this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FindingsBetween Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.InterpretationNeither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FundingUS National Institutes of Health and Operation Warp Speed.

Related Topics

Medicine

Randomized Controlled Trial

Infectious Diseases (Medical Specialty)

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Medicine Coronavirus disease 2019 (COVID-19) Randomized controlled trial 2019-20 coronavirus outbreak Internal medicine Monoclonal antibody Pediatrics Virology Antibody Immunology Outbreak Disease Infectious disease (medical specialty)

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Type: article
Language: en
Landing Page: https://discovery.ucl.ac.uk/id/eprint/10152606/
OA Status: green
Cited By: 192
References: 29
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Title: Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO):a randomised controlled trial

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Publication year: 2022

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Authors: Wesley H. Self, Uriel Sandkovsky, Cavan Reilly, David M. Vock, Robert Gottlieb, M. Mack, Kevin Golden, Emma Dishner, Andrew M. Vekstein, Emily R. Ko, Tatyana Der, John Franzone, Eyad Almasri, Mohamed Fayed, Michael R. Filbin, Kathryn A. Hibbert, Todd W. Rice, Jonathan D. Casey, J.W. Awori Hayanga, Vinay Badhwar, Bradley G. Leshnower, Milad Sharifpour, Kirk U. Knowlton, Ithan D. Peltan, Elizieta Bakowska, Justyna Kowalska, Michael E. Bowdish, Jeffrey M. Sturek, Angela J. Rogers, D. Clark Files, Jarrod Mosier, Michelle N. Gong, David J. Douin, R. Duncan Hite, Barbara W. Trautner, Mamta K. Jain, Edward M. Gardner, Akram Khan, Jens‐Ulrik Stæhr Jensen, Michael A. Matthay, Adit A. Ginde, Samuel M. Brown, Elizabeth S. Higgs, Sarah Pett, Amy Weintrob, Christina C. Chang, Daniel D. Murrary, Huldrych F. Günthard, Ellen Moquete, Greg Grandits, Nicole Engen, Birgit Grund, Shweta Sharma, Huyen Cao, Rajesh Gupta, Suzette Y. Osei, David M. Margolis, Qing Zhu, Mark N. Polizzotto, Abdel G. Babiker, Victoria J. Davey, Virginia L. Kan, Bruce Thompson, Annetine C. Gelijns, James D. Neaton, H. Clifford Lane, Jens D. Jundgren, John Tierney, Kevin Barrett, Betsey Herpin, Mary Smolskis, Susan E. Voge, Laura A. McNay, Kelly Cahill, Page Crew, Matthew Kirchoff, Ratna Sardana, Sharon Segal Raim, Joseph Chiu, Lisa E. Hensley, J. A. Lorenzo, Rebecca Mock, Kathryn Shaw‐Saliba, Judith Zuckerman, Stacey J. Adam, Judy Currier, Sarah Read, Eric Hughes, Laura Amos, Amy Carlsen, Anita Carter, Bionca Davis, Eileen Denning, Alain DuChêne, Merrie Harrison, Payton Kaiser, Joseph S. Koopmeiners, Sue Meger, Thomas A. Murray, Kien Quan

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Concepts: Medicine, Coronavirus disease 2019 (COVID-19), Randomized controlled trial, 2019-20 coronavirus outbreak, Internal medicine, Monoclonal antibody, Pediatrics, Virology, Antibody, Immunology, Outbreak, Disease, Infectious disease (medical specialty)

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referenced_works	https://openalex.org/W3040725637, https://openalex.org/W3042270788, https://openalex.org/W3083773456, https://openalex.org/W3208080692, https://openalex.org/W4226004814, https://openalex.org/W3102453076, https://openalex.org/W4210642183, https://openalex.org/W4226107878, https://openalex.org/W4212891121, https://openalex.org/W3099995976, https://openalex.org/W3206281928, https://openalex.org/W3112311859, https://openalex.org/W4225826670, https://openalex.org/W3034858522, https://openalex.org/W3111431752, https://openalex.org/W3180445914, https://openalex.org/W3125712166, https://openalex.org/W3135758766, https://openalex.org/W3115009914, https://openalex.org/W3183243707, https://openalex.org/W3169957213, https://openalex.org/W3029682964, https://openalex.org/W2943418339, https://openalex.org/W4212988737, https://openalex.org/W3063924106, https://openalex.org/W3025744748, https://openalex.org/W3113196149, https://openalex.org/W3027630905, https://openalex.org/W3137199839
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