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All Studies   Meta Analysis    Recent:   

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

Self et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(21)00751-9, TICO, NCT04501978
Dec 2021  
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Mortality -15% Improvement Relative Risk Recovery, day 90 7% primary Recovery, day 5 0% Ambavirumab/r..  TICO  LATE TREATMENT  DB RCT Is late treatment with ambavirumab beneficial for COVID-19? Double-blind RCT 354 patients in multiple countries (Dec 2020 - Mar 2021) Trial underpowered for serious outcomes c19early.org Self et al., The Lancet Infectious Dis.., Dec 2021 Favorsambavirumab Favorscontrol 0 0.5 1 1.5 2+
RCT with 182 sotrovimab patients, 176 BRII-196+BRII-198 patients, and 178 control patients, median 8 days from symptom onset, showing no significant differences and terminated early due to futility.
Efficacy is variant dependent.
Study covers sotrovimab and ambavirumab.
risk of death, 15.0% higher, RR 1.15, p = 0.72, treatment 15 of 176 (8.5%), control 13 of 178 (7.3%), adjusted per study, day 90.
risk of no recovery, 7.4% lower, RR 0.93, p = 0.48, treatment 21 of 176 (11.9%), control 27 of 178 (15.2%), adjusted per study, inverted to make RR<1 favor treatment, day 90, primary outcome.
risk of no recovery, no change, RR 1.00, p = 0.99, treatment 173, control 178, adjusted per study, inverted to make RR<1 favor treatment, pulmonary-plus ordinal outcome @day 5, day 5.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Self et al., 23 Dec 2021, Double Blind Randomized Controlled Trial, multiple countries, peer-reviewed, 67 authors, study period 16 December, 2020 - 1 March, 2021, average treatment delay 8.0 days, trial NCT04501978 (history) (TICO).
This PaperAmbavir../r..All
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
Dr Wesley H Self, Uriel Sandkovsky, Cavan S Reilly, David M Vock, Disease (R L Robert L Gottlieb, Michael Mack, Kevin Golden, Emma Dishner, Andrew Vekstein, Emily R Ko, Tatyana Der, John Franzone, Eyad Almasri, Mohamed Fayed, Michael R Filbin, Kathryn A Hibbert, Todd W Rice, Jonathan D Casey, Prof J 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 M Mosier, Michelle N Gong, David J Douin, R Duncan Hite, Barbara W Trautner, Mamta K Jain, Edward M Gardner, Akram Khan, Jens-Ulrik Jensen, Michael A Matthay, Adit A Ginde, Samuel M Brown, Elizabeth S Higgs, Sarah Pett, Amy C Weintrob, Christina C Chang, Huldrych Daniel D Murrary, Huldrych F Günthard, Ellen Moquete, MS, N Engen MS Greg Grandits, Nicole Engen, Birgit Grund, MS Shweta Sharma, Huyen Cao, Rajesh Gupta, Suzette Osei, David Margolis, Qing Zhu, Mark N Polizzotto, Abdel G Babiker, Victoria J Davey, Virginia Kan, B Taylor Thompson, Annetine C Gelijns, James D Neaton, H Clifford Lane, Jens D Jundgren, John Tierney, Kevin Barrett, Betsey R Herpin, Mary C Smolskis, Susan E Voge, Laura A Mcnay, Kelly Cahill, Page Crew, Matthew Kirchoff, Ratna Sardana, Sharon Segal Raim, Joseph Chiu, Lisa Hensley, Josua Lorenzo, Rebecca Mock, Katy Shaw-Saliba, Judith Zuckerman, Stacey J Adam, Judy Currier, Sarah Read, Eric Hughes, Laura Amos, Amy Carlsen, Anita Carter, Bionca Davis, Eileen Denning, Alain Duchene, Merrie Harrison, Payton Kaiser, Joseph Koopmeiners, Sue Meger, Thomas Murray, Kien Quan, Siu Fun Quan, Greg Thompson, Jamie Walski, Deborah Wentworth, Alan J Moskowitz, Emilia Bagiella, Karen O'sullivan, Mary E Marks, Evan Accardi, Emily Kinzel, Gabriela Bedoya, Lopa Gupta, Jessica R Overbey, Maria L Padillia, Milerva Santos, Marc A Gillinov, Marissa A Miller, Wendy C Taddei-Peters, Kathleen Fenton, Mezgebe Berhe, Clinton Haley, Christopher Bettacchi, Erin Duhaime, Madison Ryan, Sarah Burris, Felecia Jones, Samantha Villa, Samantha Want, Raven Robert, Tanquinisha Coleman, Laura Clariday, Rebecca Baker, Marian Hurutado-Rodriguez, Nazia Iram, Michelle Fresnedo, Allyson Davis, Kiara Leonard, Noelia Ramierez, Jon Thammavong, Krizia Duque, Emma Turner, Tammy Fisher, Dianna Robinson, Desirae Ransom, Erica Lusk, Aaron Killian, Adriana Palacious, Edilia Solis, Janet Jerrow, Matthew Watts, Heather Whitacre, Elizabeth Cothran, Peter K Smith, Christina E Barkauskas, Grace R Dreyer, Marie Witte, Nilima Mosaly, Ahmad Mourad, Thomas L Holland, Kathleen Lane, Andrew Bouffler, Lauren M Mcgowan, Marry Motta, Gregory Tipton, Ben Stallings, Gennifer Stout, Beth Mclendon-Arvik, Beth A Hollister, Dana M Giangiacomo, Sunil Sharma, Brian Pappers, Paul Mccarthy, Troy Krupica, Arif Sarwari, Rebecca Reece, Lisa Fornaresio, Chad Glaze, Raquel Evans, Katarina Preamble, Lisa Giblin Sutton, Sabrina Buterbaugh, Elizabeth Berry Bartolo, Roger Williams, Robin Bunner, William Bender, Jeffrey Miller, Kim T Baio, Mary K Mcbride, Michele Fielding, Sonya Mathewson, Kristina Porte, Missy Maton, Chari Ponder, Elizabeth Haley, Christine Spainhour, Susan Rogers, Derrick Tyler, Noah Wald-Dickler, Douglass Hutcheon, Amytis Towfighi, May M Lee, Meghan R Lewis, Brad Spellberg, Linda Sher, Aniket Sharma, Anna P Olds, Chris Justino, Edward Lozano, Chris Romero, Janet Leong, Valentina Rodina, Tammie Possemato, Jose Escobar, Charlene Chiu, Kevin Weissman, Andrew Barros, Kyle B Enfield, Alexandra Kadl, China J Green, Rachel M Simon, Ashley Fox, Kara Thornton, Patrick E Parrino, Stephen Spindel, Aditya Bansal, Katherine Baumgarten, Jonathan Hand, Derek Vonderhaar, Bobby Nossaman, Sylvia Laudun, Deanna Ames, Shane Broussard, Nilmo Hernandez, Geralyn Isaac, Huan Dinh, Yiling Zheng, Sonny Tran, Hunter Mcdaniel, Nicolle Crovetto, Leslie Miller, Beth Schelle, Sherry Mclean, Howard R Rothbaum, Michael S Alvarez, Shivam P Kalan, Heather H Germann, Jennifer Hendershot, Karen Maroney, Karen Herring, Sharri Cook
The Lancet Infectious Diseases, doi:10.1016/s1473-3099(21)00751-9
Background We 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. Methods In 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.
Contributors Author and collaborator contributions, including responsibility for decision to submit the manuscript, drafting of the initial manuscript, study conceptualisation, investigation, data curation, formal analysis, study supervision, and review and editing of the manuscript, are provided in the appendix (pp 4-11). JDN and GG directly accessed and verified the underlying study data. JDN had access to all the study data and had final responsibility for the decision to submit the paper for publication. Declaration of interests
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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