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Tixagevimab/cilgavimab for COVID-19
20 studies with >30,000 patients
Serious outcome risk
Tixagevimab/cilgavimab
Control
Significantly lower risk for hospitalization and cases.
Efficacy is variant dependent.
COVID-19 Tixagevimab/cilgavimab studies · October 2026
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.11, BA.5, BA.2.75, XBB2,3, XBB.1.53, XBB.1.9.13, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.14. US EUA has been revoked. mAb use may create new variants that spread globally5-7, and may be associated with increased risk of autoimmune disease8, prolonged viral loads, clinical deterioration, and immune escape6,9-13. Tixagevimab/cilgavimab was adopted in 33 countries. Recent:
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Haidar
Ashoor
Ngiam.
Covid Analysis Tixagevimab/cilgavimab for COVID-19: real-time meta-analysis of 20 studies (Version 33)
Significantly lower risk is seen for hospitalization and cases. 9 studies from 9 independent teams in 3 countries show significant benefit. Meta-analysis using the most serious outcome reported shows 29% [4‑48%] lower risk. Res..
Jul 22
 Luxi et al., Drug Safety, doi:10.1007/s40264-026-01705-2 Challenges and Opportunities for Signal Detection During Public Health Emergencies: An Historical Re-evaluation of the Disproportionality Analysis of the ADR Reporting of Anti-COVID-19 Monoclonal Antibodies in Vigibase
Disproportionality analysis of 15,250 de-duplicated individual case safety reports from VigiBase (February 2020-December 2023) identifying potential cardiovascular and neurological safety signals for monoclonal antibodies (mAbs) used in e..
Jun 18
 Haidar et al., NCT05648110 Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA)
104% higher mortality (p=0.12). RCT 1,663 immunocompromised patients showing higher mortality with tixagevimab/cilgavimab, without statistical significance. Tixagevimab/cilgavimab may have lost efficacy with variants at the time but retain side effects.
Jan 31
 Ngiam et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2026.108435 Early administration of neutralising monoclonal antibodies and post-acute sequelae of COVID-19
Retrospective 19,689 hospitalized COVID-19 patients in Singapore showing no significant reduction in overall post-acute sequelae of COVID-19 (PASC) with early monoclonal antibody treatment, but increased risk of autoimmune complications. ..
Dec 31
2025
 Martin-Blondel et al., iScience, doi:10.1016/j.isci.2025.114226 Viral clearance and escape during therapy of COVID-19 outpatients: A prospective cohort study
Prospective cohort study of 114 high-risk COVID-19 outpatients showing that monoclonal antibody treatments with suboptimal neutralizing activity against infecting variants resulted in higher viral loads and increased emergence of escape m..
Oct 1
2025
 Focosi et al., Infection and Drug Resistance, doi:10.2147/IDR.S540928 The Emergence of Escape Mutations in COVID-19 Following Anti-Spike Monoclonal Antibody Treatment: How Do We Tackle It?
Review of treatment-emergent resistance to anti-spike monoclonal antibodies in COVID-19 patients. Monotherapies like bamlanivimab and sotrovimab showed very high resistance rates, while combination approaches had lower risk. The rapid evo..
Aug 29
2025
 Deo et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofaf542 Rapid Elimination of Culturable SARS-CoV-2 With Intramuscular or Intravenous Administration of Antiviral Monoclonal Antibody Therapy
RCT 313 outpatients showing that that intramuscular delivery of tixagevimab/cilgavimab is as effective as intravenous administration for viral clearance.
May 21
2025
 Dluzynski et al., Scientific Reports, doi:10.1038/s41598-025-02240-3 Dose-dependent impact of tixagevimab–cilgavimab as primary prevention against SARS-CoV-2 in immunocompromised individuals
70% more cases (p=0.08). Retrospective 597 immunocompromised individuals showing no significant difference in infection rates over the entire study period. However, when truncating data to November 1, 2022 (before resistant variants dominated), effectiveness incr..
Mar 13
2025
 Vukovikj et al., Eurosurveillance, doi:10.2807/1560-7917.ES.2025.30.10.2400252 Impact of SARS-CoV-2 variant mutations on susceptibility to monoclonal antibodies and antiviral drugs: a non-systematic review, April 2022 to October 2024
Review of SARS-CoV-2 variant mutations and their impact on susceptibility to monoclonal antibodies and antivirals. Mutations in the ORF1ab region led to decreased susceptibility to paxlovid, while nsp12 mutations reduced efficacy for remd..
Feb 6
2025
 Mourad et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2025.02.002 Long-term outcomes of passive immunotherapy for COVID-19: a pooled analysis of a large multinational platform randomized clinical trial
23% lower mortality (p=0.08) and 3% lower combined mortality/hospitalization (p=0.77). Analysis of 2,311 hospitalized COVID-19 patients from four randomized controlled trials (ACTIV-3/TICO) showing no significant difference in long-term mortality with sotrovimab, amubarvimab/romlusevimab, tixagevimab-cilgavimab, or ensovibep.
Jan 29
2025
 Chua et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofae631.2172 Evaluating the use of Monoclonal Antibodies - Sotrovimab, Casirivimab/Imedvimab (REGEN-COV) and Tixagevimab/Cilgavimab (EVUSHELD) for COVID-19 Treatment in Singapore
8% lower ICU admission (p=1) and 33% lower need for oxygen therapy (p=0.17). PSM retrospective 366 hospitalized COVID-19 patients in Singapore showing no statistically significant reduction in severe outcomes with monoclonal antibodies (mAbs), except for lower oxygen use in patients treated with sotrovimab during ..
Sep 19
2024
 Kumar et al., Antiviral Research, doi:10.1016/j.antiviral.2024.106006 Identification of antibody-resistant SARS-CoV-2 mutants via N4-Hydroxycytidine mutagenesis
In vitro selection study identifying SARS-CoV-2 spike mutations that confer resistance to therapeutic antibodies. Using a Wuhan-like strain and omicron B.1.1.529, the authors used sequential mutagenesis with the molnupiravir active compou..
Aug 19
2024
 Ashoor, D., MDPI AG, doi:10.20944/preprints202408.1340.v1 In Silico Evaluation of Ten Monoclonal Antibodies Neutralization Power of SARS-CoV-2 Variants EG.5, BA.2.86 and JN.1
In silico study evaluating the neutralization power of 10 monoclonal antibodies (9 previously EUA-granted, 1 under clinical investigation) against SARS-CoV-2 variants EG.5, BA.2.86, and JN.1. Most available neutralizing antibodies have si..
Aug 11
2024
 Focosi, D., Current Topics in Microbiology and Immunology, doi:10.1007/82_2024_268 Monoclonal Antibody Therapies Against SARS-CoV-2: Promises and Realities
Review of monoclonal antibodies for SARS-CoV-2. Author notes that the omicron variant has reset achievements to date.
Aug 8
2024
 Casadevall et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae408 Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship
Review arguing against use of single monoclonal antibodies for COVID-19 treatment, particularly in immunosuppressed patients, due to the risk of rapidly selecting for resistant viral variants. Authors suggest that while monoclonal antibod..
Aug 5
2024
 Enyeji et al., Viral Immunology, doi:10.1089/vim.2024.0034 Effective Treatment of COVID-19 Infection with Repurposed Drugs: Case Reports
Review of the successful treatment of COVID-19 using existing medications including HCQ, AZ, ivermectin, famotidine, monoclonal antibodies, and others. Authors note that the typical treatment of severe viral infections with multiple thera..
May 28
2024
 Bes-Berlandier et al., BMC Infectious Diseases, doi:10.1186/s12879-024-09269-1 Management of immunosuppression in lung transplant recipients and COVID-19 outcomes: an observational retrospective cohort-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.
Apr 30
2024
 Wang et al., European Review for Medical and Pharmacological Sciences, doi:10.26355/eurrev_202404_35925 The safety signal detection and analysis of monoclonal antibodies against SARS-CoV-2 based on real-world evidence – the suitable selectivity for different populations
FDA adverse event reporting analysis for bebtelovimab, tixagevimab/cilgavimab, and sotrovimab, showing distinct safety profiles with concerning adverse events for each drug. Bebtelovimab showed the highest associations with gastrointestin..
Mar 31
2024
 Solera et al., American Journal of Transplantation, doi:10.1016/j.ajt.2024.03.011 Longitudinal outcomes of COVID-19 in solid organ transplant recipients from 2020 to 2023
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 30
2024
 Hattab et al., Infection, doi:10.1007/s15010-024-02223-y SARS-CoV-2 journey: from alpha variant to omicron and its sub-variants
Review of SARS-CoV-2 variants showing increased transmissibility, disease severity, and immune escape with mutations in the spike protein receptor binding domain. Authors cover variants from the initial D614G mutation through omicron sub-..
Feb 16
2024
 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 30
2023
 Uraki et al., iScience, doi:10.1016/j.isci.2023.108147 Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate
In vitro and animal study showing that the SARS-CoV-2 omicron subvariant XBB.1.9.1 has similar antigenicity, antiviral susceptibility, and replicative ability compared to XBB.1.5. Casirivimab, imdevimab, tixagevimab, cilgavimab, sotrovima..
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..
Oct 20
2023
 Fomina et al., Frontiers in Immunology, doi:10.3389/fimmu.2023.1259725 Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period
Prospective study of 77 COVID-19 outpatients showing improved efficacy with tixagevimab/cilgavimab compared to regdanvimab during Omicron variant dominance.
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.
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., Preprints, 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.
Jan 8
2023
 Soeroto et al., Reviews in Medical Virology, doi:10.1002/rmv.2420 Efficacy and safety of tixagevimab‐cilgavimab as pre‐exposure prophylaxis for COVID‐19: A systematic review and meta‐analysis
83% lower mortality (p=0.05), 87% lower hospitalization (p<0.0001), 87% lower severe cases (p<0.0001), and 76% fewer cases (p<0.0001). Meta analysis of 6 studies showing significantly lower COVID-19 cases, hospitalization, severity, and mortality with tixagevimab/cilgavimab prophylaxis.
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 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..
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
23% lower mortality (p=0.08), 3% lower combined mortality/hospitalization (p=0.77), 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. Long-term results are reported in [Mourad]
Jun 21
2022
 Keam, S., Drugs, doi:10.1007/s40265-022-01731-1 Tixagevimab + Cilgavimab: First Approval
Review of tixagevimab + cilgavimab for the prevention and treatment of COVID-19. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that bind to distinct sites on the SARS-CoV-2 spike protein. In March 2022, the combination ..
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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