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 US EUA has been revoked.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 |
(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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
(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 |
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.
Thanks for your feedback! Please search before submitting papers and note
that studies are listed under the date they were first available, which may be
the date of an earlier preprint.