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Summary of COVID-19 tixagevimab/cilgavimab studies

Studies   Meta Analysis   Hide extended summaries

5,172 patient tixagevimab/cilgavimab prophylaxis RCT: 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.

Apr 2022, New England J. Medicine, http://www.nejm.org/doi/10.1056/NEJMoa2116620, https://c19p.org/levin2

903 patient tixagevimab/cilgavimab early treatment RCT: 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.

Jun 2022, The Lancet Respiratory Medicine, https://www.sciencedirect.com/science/article/pii/S2213260022001801, https://c19p.org/montgomery

1,417 patient tixagevimab/cilgavimab late treatment RCT: 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.

Jul 2022, The Lancet Respiratory Medicine, https://www.sciencedirect.com/science/article/pii/S2213260022002156, https://c19p.org/holland

430 patient tixagevimab/cilgavimab prophylaxis study: 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 2022, Kidney Int., https://www.sciencedirect.com/science/article/pii/S0085253822005506, https://c19p.org/kaminski

8,087 patient tixagevimab/cilgavimab prophylaxis PSM study: 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.

May 2022, medRxiv, https://www.medrxiv.org/content/10.1101/2022.05.28.22275716, https://c19p.org/youngxu

5,124 patient tixagevimab/cilgavimab prophylaxis study: 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 2022, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac625/6651663, https://c19p.org/kertes

3,515 patient tixagevimab/cilgavimab prophylaxis study: 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.

Oct 2022, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac855/6780937, https://c19p.org/najjardebbiny3

444 patient tixagevimab/cilgavimab prophylaxis study: 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.

Dec 2022, American J. Transplantation, https://www.sciencedirect.com/science/article/pii/S1600613523000655, https://c19p.org/aljurdi

37 patient tixagevimab/cilgavimab prophylaxis study: 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 infections occurred, whereas 3 infections and 1 death occurred among 12 comparable patients not receiving prophylaxis.

Jul 2022, Cancer, https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34354, https://c19p.org/ollila

1,121 patient tixagevimab/cilgavimab prophylaxis RCT: 42% fewer symptomatic cases (p=0.06).
1,121 patient PEP RCT showing lower symptomatic cases with tixagevimab/cilgavimab, without statistical significance.

Dec 2021, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac899/6835900, https://c19p.org/levin4

226 patient tixagevimab/cilgavimab late treatment RCT: 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 terminated early due to concerns about reduced efficacy against circulating variants.

Feb 2024, J. Infection, https://www.sciencedirect.com/science/article/pii/S0163445324000549, https://c19p.org/hites

1,975 patient tixagevimab/cilgavimab prophylaxis study: 26% lower severe cases (p=0.48).
Retrospective 1,975 solid organ transplant recipients with COVID-19 showing lower risk of severe cases with tixagevimab/cilgavimab prophylaxis, without statistical significance.

Mar 2024, American J. Transplantation, https://www.sciencedirect.com/science/article/pii/S1600613524002077, https://c19p.org/solera2

782 patient tixagevimab/cilgavimab prophylaxis 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.

Sep 2023, Crohn's & Colitis 360, https://academic.oup.com/crohnscolitis360/article/5/3/otad047/7261634, https://c19p.org/desai3

64 patient tixagevimab/cilgavimab prophylaxis study: 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.

Aug 2023, Hemasphere, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10429980/, https://c19p.org/din

108 patient tixagevimab/cilgavimab early treatment study: 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.

Jan 2023, MDPI AG, https://www.preprints.org/manuscript/202301.0359/v1, https://c19p.org/lombardi

91 patient tixagevimab/cilgavimab prophylaxis study: 10% higher progression (p=1).
Retrospective 91 lung transplant recipients with COVID-19 showing no significant difference in poor outcomes with casirivimab/imdevimab or tixagevimab/cilgavimab prophylaxis in univariate analysis.

May 2024, BMC Infectious Diseases, https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-024-09269-1, https://c19p.org/besberlandiertc

546 patient tixagevimab/cilgavimab prophylaxis PSM study: 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.

May 2023, Transplantation Direct, https://journals.lww.com/10.1097/TXD.0000000000001485, https://c19p.org/sindu
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