Summary of COVID-19 tixagevimab/cilgavimab studies

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

2. Montgomery 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

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

3. Holland et al., Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

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

4. Kaminski et al., COVID-19 morbidity decreases with tixagevimab–cilgavimab preexposure prophylaxis in kidney transplant recipient nonresponders or low-vaccine responders

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

5. Young-Xu et al., Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA Electronic Data

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

6. Kertes et al., Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality

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

7. Najjar-Debbiny et al., Effectiveness of Evusheld in Immunocompromised Patients: Propensity Score-Matched Analysis

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

8. Al Jurdi et al., Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave

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

9. Ollila et al., Seroconversion and outcomes after initial and booster COVID‐19 vaccination in adults with hematologic malignancies

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

10. Levin et al., AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19

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

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

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

12. Solera et al., Longitudinal outcomes of COVID-19 in solid organ transplant recipients from 2020 to 2023

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

13. Desai et al., Tixagevimab and Cilgavimab (Evusheld) as Pre-exposure Prophylaxis for COVID-19 in Patients With Inflammatory Bowel Disease: A Propensity Matched Cohort Study

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

14. Din et al., COVID-19 infection among CAR-T cell therapy recipients: A single center experience

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

15. Lombardi et al., 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

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, Preprints, https://www.preprints.org/manuscript/202301.0359/v1, https://c19p.org/lombardi

16. Bes-Berlandier et al., Management of immunosuppression in lung transplant recipients and COVID-19 outcomes: an observational retrospective cohort-study

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

17. Sindu et al., Pre-exposure Prophylaxis with Tixagevimab-cilgavimab did not Reduce Severity of COVID-19 in Lung Transplant Recipients with Breakthrough Infection

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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