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study COVID-19 treatment researchTixagevimab/cilgavimabTixagev../c.. (more..)
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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality -368% Improvement Relative Risk Hospitalization 33% Viral clearance -24% Tixagevimab/c..  Lombardi et al.  EARLY TREATMENT Is early treatment with tixagevimab/cilgavimab beneficial for COVID-19? Retrospective 108 patients in Italy (August - October 2022) Study compares with other mAbs, results vs. placebo may differ Higher mortality (p=0.32) and worse viral clearance (p=0.3), not sig. Lombardi et al., MDPI AG, January 2023 Favors tixagevimab/ci.. Favors other mAbs

Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients

Lombardi et al., MDPI AG, doi:10.20944/preprints202301.0359.v1
Jan 2023  
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37th 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.
4,000+ studies for 60+ treatments.
Retrospective immunocompromised patients, showing no significant difference between tixagevimab/cilgavimab and other mAbs.
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.
This study is excluded in the after exclusion results of meta analysis: study compares against another treatment showing significant efficacy.
risk of death, 368.4% higher, RR 4.68, p = 0.32, treatment 1 of 19 (5.3%), control 1 of 89 (1.1%), day 14.
risk of hospitalization, 33.1% lower, RR 0.67, p = 1.00, treatment 1 of 19 (5.3%), control 7 of 89 (7.9%), NNT 38, day 14.
risk of no viral clearance, 23.7% higher, RR 1.24, p = 0.30, treatment 14 of 19 (73.7%), control 53 of 89 (59.6%), day 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lombardi et al., 19 Jan 2023, retrospective, Italy, preprint, 21 authors, study period 28 August, 2022 - 15 October, 2022, this trial compares with another treatment - results may be better when compared to placebo. Contact:
This PaperTixagev../c..All
Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients
MD. Andrea Lombardi, Giulia Viero, Simone Villa, Simona Biscarini, Emanuele Palomba, Cecilia Azzara', Nathalie Iannotti, Bianca Mariani, Camilla Genovese, Mara Tomasello, Anna Tonizzo, Marco Fava, Antonia Grazia Valzano, Letizia Morlacchi, Maria Francesca Donato, Giuseppe Castellano, Ramona Cassin, Maria Carrabba, Antonio Muscatello, Andrea Gori, Alessandra Bandera
The statements, opinions, and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions, or products referred to in the content.
Authors contributions AL, SV, AG, and AB conceived the study. GV, SB, EP, CA, NI, BM, CG, MT, AT, MF, AGV, LCM, FD, GC, RC, MC and AM enrolled the patients and collected clinical data. AL and SV performed the statistical analysis. AL, GV and SV wrote the first draft of the manuscript. All the other authors reviewed the final version of the manuscript. Conflict of interests AL Gilead Sciences Inc. and Insmed Italia. AB Quiagen, Pfizer, Nordic Pharma, ViiV, SOBI, and Gilead Sciences. FD Kedrion, Gilead Sciences, Biotest, and Novartis. AM Gilead Sciences, Menarini, and Nordic Pharma. SB Infectopharma. MC Takeda and Kedrion. All the other authors have nothing to declare.
Aifa, AIFA Evusheld trattamento 2022
Arora, Kempf, Nehlmeier, Schulz, Jäck et al., Omicron sublineage BQ.1.1 resistance to monoclonal antibodies, Lancet Infect Dis, doi:10.1016/S1473-3099(22)00733-2
Biscarini, Villa, Genovese, Tomasello, Tonizzo et al., Safety Profile and Outcomes of Early COVID-19 Treatments in Immunocompromised Patients: A Single-Centre Cohort Study, Biomedicines, doi:10.3390/biomedicines10082002
Ecdc, ECDC VOCs monitoring
Holland, Ginde, Paredes, Murray, Engen et al., Tixagevimabcilgavimab for treatment of patients hospitalised with COVID-19: a randomised, doubleblind, phase 3 trial, Lancet Respir Med, doi:10.1016/S2213-2600(22)00215-6
Jurdi, Morena, Cote, Bethea, Azzi et al., Tixagevimab/cilgavimab preexposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave, Am J Transplant, doi:10.1111/ajt.17128
Levin, Ustianowski, Wit, Launay, Avila et al., Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19, N Engl J Med, doi:10.1056/NEJMoa2116620
Loo, Mctamney, Arends, Abram, Aksyuk et al., The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans, Sci Transl Med, doi:10.1126/scitranslmed.abl8124
Mcconnell, Harte, Walsh, Murphy, Barry, Comparative effectiveness of neutralising monoclonal antibodies in high risk COVID-19 patients: a Bayesian network meta-analysis, Sci Rep, doi:10.1038/s41598-022-22431-6
Montgomery, Hobbs, Padilla, Arbetter, Templeton et al., Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial, Lancet Respir Med, doi:10.1016/S2213-2600(22)00180-1
Nguyen, Flahault, Chavarot, Melenotte, Cheminant et al., Preexposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients, Clin Microbiol Infect, doi:10.1016/j.cmi.2022.07.015
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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