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Tixagevimab/cilgavimab for COVID-19
10 studies from 222 scientists
26,602 patients in 3 countries
Statistically significant improvement for hospitalization and cases.
6 studies from 6 independent teams in 2 countries show statistically significant improvements in isolation.
Efficacy is variant dependent.
COVID-19 Tixagevimab/cilgavimab studies. Jun 2023. c19early.org/tc
0 0.5 1 1.5+ All studies 47% With exclusions 49% Mortality 36% Hospitalization 59% Cases 47% Viral clearance -24% RCTs 32% RCT mortality 29% Prophylaxis 58% Early -29% Late 30% Favorstixagevimab/ci.. Favorscontrol
Tixagevimab/cilgavimab COVID-19 studies. Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.1 [Planas]. US EUA has been revoked. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape [Choudhary]. Recent:
Sindu.
Tixagevimab/cilgavimab has been officially adopted in 29 countries. Submit updates/corrections.
Jun 3
Covid Analysis (Preprint) (meta analysis) Tixagevimab/cilgavimab for COVID-19: real-time meta analysis of 10 studies
Statistically significant improvements are seen for hospitalization and cases. 6 studies from 6 independent teams in 2 different countries show statistically significant improvements in isolation (4 for the most serious outcome). • Meta..
May 12
Sindu et al., Transplantation Direct, doi:10.1097/txd.0000000000001485 Pre-exposure Prophylaxis with Tixagevimab-cilgavimab did not Reduce Severity of COVID-19 in Lung Transplant Recipients with Breakthrough Infection
96% higher ventilation [p=0.58], 210% higher ICU admission [p=0.33], 53% lower hospitalization [p=0.18], and 29% fewer symptomatic cases [p=0.14]. Retrospective 546 lung transplant recipients, 203 receiving tixagevimab/cilgavimab, and 343 out of state or declining treatment, showing a trend towards lower incidence of cases, but no significant difference in clinical outcomes.
Jan 19
Lombardi et al., MDPI AG, doi:10.20944/preprints202301.0359.v1 (Preprint) 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
368% higher mortality [p=0.32], 33% lower hospitalization [p=1], and 24% worse viral clearance [p=0.3]. Retrospective immunocompromised patients, showing no significant difference between tixagevimab/cilgavimab and other mAbs.
Nov 22
Levin et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac899 AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19
75% lower severe cases [p=0.33] and 42% fewer symptomatic cases [p=0.06]. 1,121 patient PEP RCT showing lower symptomatic cases with tixagevimab/cilgavimab, without statistical significance.
Nov 17
Planas et al., bioRxiv, doi:10.1101/2022.11.17.516888 (Preprint) (In Vitro) Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies
In Vitro study suggesting a lack of efficacy for tixagevimab/vilgavimab with BA.2.75.2, BQ.1.1, and BA.4.6.
Oct 31
Najjar-Debbiny et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac855 Effectiveness of Evusheld in Immunocompromised Patients: Propensity Score-Matched Analysis
59% lower hospitalization [p=0.02] and 25% fewer cases [p=0.03]. Retrospective 732 immunocompromised patients in Israel treated with tixagevimab/cilgavimab, and 2,812 matched controls, showing significantly lower cases and hospitalization with treatment.
Jul 29
Kertes et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac625 Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality
92% lower combined mortality/hospitalization [p=0.01] and 47% fewer cases [p=0.01]. Retrospective 825 immunocompromised individuals treated with tixagevimab-cilgavimab and 4229 untreated in Israel, showing significantly lower infection and hospitalization/death with treatment. Omicron was the dominant variant.
Jul 8
Holland et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00215-6 Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial
30% lower mortality [p=0.03] and 7% improved recovery [p=0.21]. RCT with 710 hospitalized patients treated with tixagevimab/cilgavimab, and 707 placebo patients, showing lower mortality with treatment.
Jun 7
Montgomery et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00180-1 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
no change in mortality [p=1], 50% lower severe cases [p=0.01], and 57% lower hospitalization [p=0.002]. RCT 910 outpatients in the USA, 456 treated with tixagevimab/cilgavimab, showing significantly lower combined severe COVID-19/death with treatment.
May 29
Young-Xu et al., medRxiv, doi:10.1101/2022.05.28.22275716 (Preprint) Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA Electronic Data
64% lower mortality [p=0.004], 69% lower combined death/hospitalization/cases [p<0.0001], 87% lower hospitalization [p=0.04], and 66% fewer cases [p=0.03]. PSM retrospective 1,848 immunocompromised patients given tixagevimab/cilgavimab prophylaxis, showing lower mortality, hospitalization, and cases.
Apr 20
Levin et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116620 Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19
86% lower mortality [p=0.11] and 82% fewer symptomatic cases [p<0.0001]. PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment.
Dec 8
2021
FDA (Preprint) Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab)
40% fewer symptomatic cases [p=0.07]. PEP RCT with 749 tixagevimab/cilgavimab patients and 372 control patients, showing lower risk of symptomatic cases with treatment, without statistical significance. STORM CHASER. NCT04625972.
Dec 8
2021
Levin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1646 (Preprint) PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults
86% lower mortality [p=0.11] and 76% fewer symptomatic cases [p=0.0005]. PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment. Followup data is from [fda.gov].
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, 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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