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Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): a phase 3, randomized, double-blind, placebo-controlled trial

Hites et al., Journal of Infection, doi:10.1016/j.jinf.2024.106120, DisCoVeRy, NCT04315948

Feb 2024

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Tixagevimab/cilgavimab

36th treatment shown to reduce risk in May 2022

^*, now known with p = 0.00002 from 15 studies, recognized in 30 countries. Efficacy is variant dependent.

Lower risk for mortality, hospitalization, and cases.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19early.org

RCT 173 hospitalized COVID-19 patients showing no significant difference in clinical status, time to recovery, viral clearance, or mortality with tixagevimab/cilgavimab. Mortality was lower, without statistical significance. The trial was terminated early due to concerns about reduced efficacy against circulating variants.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, BQ.1.1 Planas, BA.5, BA.2.75, XBB Haars, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.1 Pochtovyi.

Although the 40% lower mortality is not statistically significant, it is consistent with the significant 42% lower mortality [16‑60%] from meta analysis of the 10 mortality results to date.

1. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

2. Planas et al., Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies, bioRxiv, doi:10.1101/2022.11.17.516888.biorxiv.org, doi.org.

3. Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.mdpi.com, doi.org.

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risk of death, 39.9% lower, RR 0.60, p = 0.17, treatment 12 of 123 (9.8%), control 16 of 103 (15.5%), NNT 17, odds ratio converted to relative risk, day 90.

risk of 7-point scale, 17.6% higher, OR 1.18, p = 0.52, treatment 123, control 103, inverted to make OR<1 favor treatment, day 15, primary outcome, RR approximated with OR.

recovery time, 1.0% lower, relative time 0.99, p = 0.93, treatment 123, control 103, inverted to make RR<1 favor treatment.

time to discharge, 9.1% lower, relative time 0.91, p = 0.49, treatment 123, control 103, inverted to make RR<1 favor treatment.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Hites et al., 16 Feb 2024, Double Blind Randomized Controlled Trial, placebo-controlled, France, peer-reviewed, 86 authors, trial NCT04315948 (history) (DisCoVeRy). Contact: maya.hites@hubruxelles.be.

This Paper Tixagev../c..All

Abstract: Journal Pre-proof Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): a phase 3, randomized, doubleblind, placebo-controlled trial Maya Hites Clément R. Massonnaud Simon Jamard François Goehringer François Danion Jean Reignier Nathalie de Castro Denis Garot Eva Larranaga Lapique Karine Lacombe Violaine Tolsma Emmanuel Faure Denis Malvy Thérèse Staub Johan Courjon France Cazenave-Roblot Anne Ma Dyrhol Riise Paul Leturnier Guillaume Martin-Blondel Claire Roger Karolina Akinosoglou Vincent Le Moing Lionel Piroth Pierre Sellier Xavier Lescure Marius Trøseid Philippe Clevenbergh Olav Dalgard Sébastien Gallien Marie Gousseff Paul Loubet Fanny Vardon-Bounes Clotilde Visée Leila Belkhir Élisabeth Botelho-Nevers André Cabié Anastasia Kotanidou Fanny Lanternier Elisabeth Rouveix-Nordon Susana Silva Guillaume Thiery Pascal Poignard Guislaine Carcelain Alpha Diallo, Noémie Mercier, Vida Terzic Maude Bouscambert-Duchamp, Alexandre Gaymard Mary-Anne Trabaud Grégory Destras, Laurence Josset Drifa Belhadi Nicolas Billard Jérémie Guedj Thi-Hong-Lien Han Sandrine Couffin-Cadiergues Aline Dechanet Christelle Delmas, Hélène Esperou Claire Fougerou-Leurent Soizic Le Mestre Anabelle Métois Marion Noret Isabelle Bally, Sebastián Dergan-Dylon Sarah Tubiana Ouifiya Kalif Nathalie Bergaud, Benjamin Leveau Joe Eustace Richard Greil Edit Hajdu Monika Halanova Jose-Artur Paiva Anna Piekarska Jesus Rodriguez Baño Kristian Tonby Milan Trojánek Sotirios Tsiodras Serhat Unal Charles Burdet Dominique Costagliola Yazdan Yazdanpanah Nathan Peiffer-Smadja France Mentré Florence Ader PII: S0163-4453(24)00054-9 DOI: https://doi.org/10.1016/j.jinf.2024.106120 Reference: YJINF106120 To appear in: Journal of Infection Accepted date: 8 Please cite this article as: Maya Hites, Clément R. Massonnaud, Simon Jamard, François Goehringer, François Danion, Jean Reignier, Nathalie de Castro, Denis Garot, Eva Larranaga Lapique, Karine Lacombe, Violaine Tolsma, Emmanuel Faure, Denis Malvy, Thérèse Staub, Johan Courjon, France Cazenave-Roblot, Anne Ma Dyrhol Riise, Paul Leturnier, Guillaume Martin-Blondel, Claire Roger, Karolina Akinosoglou, Vincent Le Moing, Lionel Piroth, Pierre Sellier, Xavier Lescure, Marius Trøseid, Philippe Clevenbergh, Olav Dalgard, Sébastien Gallien, Marie Gousseff, Paul Loubet, Fanny Vardon-Bounes, Clotilde Visée, Leila Belkhir, Élisabeth Botelho-Nevers, André Cabié, Anastasia Kotanidou, Fanny Lanternier, Elisabeth Rouveix-Nordon, Susana Silva, Guillaume Thiery, Pascal Poignard, Guislaine Carcelain, Alpha Diallo, Noémie Mercier, Vida Terzic, Maude Bouscambert-Duchamp, Alexandre Gaymard, Mary-Anne Trabaud, Grégory Destras, Laurence Josset, Drifa Belhadi, Nicolas Billard, Jérémie Guedj, Thi-Hong-Lien Han, Sandrine Couffin-Cadiergues, Aline Dechanet, Christelle Delmas, Hélène Esperou, Claire Fougerou-Leurent, Soizic Le Mestre, Anabelle Métois, Marion Noret, Isabelle Bally, Sebastián Dergan-Dylon, Sarah Tubiana, Ouifiya Kalif, Nathalie Bergaud, Benjamin Leveau, Joe Eustace, Richard Greil, Edit Hajdu, Monika Halanova, Jose-Artur Paiva, Anna Piekarska, Jesus Rodriguez Baño, Kristian Tonby, Milan Trojánek, Sotirios Tsiodras, Serhat Unal, Charles Burdet, Dominique Costagliola, Yazdan Yazdanpanah, Nathan Peiffer-Smadja, France Mentré and Florence Ader, Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): a phase 3, randomized, double-blind, placebo-controlled..

Late treatment
is less effective

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