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c19early.org COVID-19 treatment researchTixagevimab/cilgavimabTixagev../c.. (more..)
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Tixagevimab/cilgavimab for COVID-19
15 studies from 375 scientists
27,464 patients in 4 countries
Statistically significant lower risk for mortality, hospitalization, and cases.
9 studies from 9 independent teams in 3 countries show statistically significant improvements.
Efficacy is variant dependent.
COVID-19 Tixagevimab/cilgavimab studies. Mar 2024. c19early.org
0 0.5 1 1.5+ All studies 46% With exclusions 48% Mortality 42% Hospitalization 63% Recovery 6% Cases 69% Viral clearance -24% RCTs 33% RCT mortality 31% Prophylaxis 54% Early -29% Late 32% Favorstixagevimab/ci.. Favorscontrol
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, 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. US EUA has been revoked. mAb use may create new variants that spread globally Focosi, Leducq, and may be associated with prolonged viral loads, clinical deterioration, and immune escape Choudhary, Günther, Leducq. Recent:
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Pochtovyi
Leducq.
Tixagevimab/cilgavimab was adopted in 30 countries. Submit updates/corrections.
Mar 3
Covid Analysis Tixagevimab/cilgavimab for COVID-19: real-time meta analysis of 15 studies
Statistically significant lower risk is seen for mortality, hospitalization, and cases. 9 studies from 9 independent teams in 3 countries show statistically significant improvements. Meta analysis using the most serious outcome reported s..
Feb 16
Hites et al., Journal of Infection, doi:10.1016/j.jinf.2024.106120 Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): a phase 3, randomized, double-blind, placebo-controlled trial
40% lower mortality (p=0.17), 18% worse 7-point scale results (p=0.52), 1% faster recovery (p=0.93), and 9% higher hospital discharge (p=0.49). 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..
Nov 23
2023
Leducq et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiad523 Spike protein genetic evolution in patients at high-risk of severe COVID-19 treated by monoclonal antibodies
Prospective study of 264 high-risk COVID-19 patients treated with monoclonal antibodies. Tixagevimab/cilgavimab was associated with 5 times higher risk of emergence of mutations. Treatment with sotrovimab was linked to mutations associate..
Sep 28
2023
Pochtovyi et al., Vaccines, doi:10.3390/vaccines11101533 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
In Vitro study showing sharply reduced neutralization of SARS-CoV-2 variants 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 with monoclonal antibodies cilgavimab, tixagevimab, imdevimab, etsevimab, casirivim..
Sep 27
2023
Haars et al., Microorganisms, doi:10.3390/microorganisms11102417 Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023
Analysis of 7,950 SARS-CoV-2 samples from central Sweden collected between March 2022 and May 2023 tracking the prevalence of omicron sublineages and mutations in the spike protein conferring resistance to monoclonal antibodies over time...
Sep 6
2023
Desai et al., Crohn's & Colitis 360, doi:10.1093/crocol/otad047 Tixagevimab and Cilgavimab (Evusheld) as Pre-exposure Prophylaxis for COVID-19 in Patients With Inflammatory Bowel Disease: A Propensity Matched Cohort Study
12% lower hospitalization (p=0.81) and 35% more cases (p=0.18). TriNetX PSM retrospective 408 IBD patients receiving tixagevimab/cilgavimab and matched controls, showing no significant difference in COVID-19 cases or hospitalization.
Aug 10
2023
Focosi et al., Drug Resistance Updates, doi:10.1016/j.drup.2023.100991 Analysis of SARS-CoV-2 mutations associated with resistance to therapeutic monoclonal antibodies that emerge after treatment
Review of reports of treatment-emergent resistance to COVID-19 monoclonal antibodies (mAbs), showing that some post-mAb treatment mutations appeared to spread globally soon after the mAb was introduced, raising concerns about transmission..
Aug 8
2023
Din et al., Hemasphere, doi:10.1097/01.HS9.0000973036.97124.6c COVID-19 infection among CAR-T cell therapy recipients: A single center experience
19% lower hospitalization (p=0.77). Retrospective 64 COVID+ CAR-T cell therapy recipients, showing lower hospitalization with tixagevimab/cilgavimab prophylaxis in unadjusted results, without statistical significance.
Jul 11
2022
Ollila et al., Cancer, doi:10.1002/cncr.34354 Seroconversion and outcomes after initial and booster COVID‐19 vaccination in adults with hematologic malignancies
76% lower mortality (p=0.32) and 90% fewer cases (p=0.03). Retrospective 378 patients with hematologic malignancies analyzing seroconversion and outcomes post-vaccination. Among 25 seronegative patients after booster vaccination who received tixagevimab/cilgavimab prophylaxis, no COVID-19 infecti..
May 12
2023
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
2023
Lombardi et al., MDPI AG, doi:10.20944/preprints202301.0359.v1 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.
Dec 31
2022
Al Jurdi et al., American Journal of Transplantation, doi:10.1111/ajt.17128 Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave
86% lower mortality (p=0.25), 83% lower hospitalization (p=0.12), and 66% fewer cases (p=0.001). Retrospective cohort study of 444 solid organ transplant recipients showing significantly lower risk of SARS-CoV-2 breakthrough infections with tixagevimab/cilgavimab pre-exposure prophylaxis compared to controls during the omicron period.
Nov 17
2022
Planas et al., bioRxiv, doi:10.1101/2022.11.17.516888 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
2022
Kaminski et al., Kidney International, doi:10.1016/j.kint.2022.07.008 COVID-19 morbidity decreases with tixagevimab–cilgavimab preexposure prophylaxis in kidney transplant recipient nonresponders or low-vaccine responders
92% lower mortality (p=0.07), 96% lower ICU admission (p=0.001), 95% lower hospitalization (p=0.001), and 99% fewer symptomatic cases (p=0.001). Retrospective 430 kidney transplant recipients showing significantly lower symptomatic COVID-19 and hospitalization with tixagevimab/cilgavimab preexposure prophylaxis compared to 97 patients who did not receive it, during an omicron wave.
Oct 31
2022
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
2022
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
2022
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
2022
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 severe cases and hospitalization with treatment, but no difference in mortality.
May 29
2022
Young-Xu et al., medRxiv, doi:10.1101/2022.05.28.22275716 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
2022
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
Levin et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac899 (date from FDA disclosure of results) AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19
42% fewer symptomatic cases (p=0.06). 1,121 patient PEP RCT showing lower symptomatic cases with tixagevimab/cilgavimab, without statistical significance.
Dec 8
2021
Levin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1646 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].
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