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Early, Late, PrEP, PEP |
Covid Analysis (Preprint) (meta analysis) |
meta-analysis |
Tixagevimab/cilgavimab for COVID-19: real-time meta analysis of 6 studies |
Details
• Statistically significant improvements are seen for mortality, hospitalization, and cases. 5 studies from 5 independent teams in 2 different countries show statistically significant improvements in isolation (3 for the most serious outc.. |
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Early, Late, PrEP, PEP
Early, Late, PrEP, PEP
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Tixagevimab/cilgavimab for COVID-19: real-time meta analysis of 6 studies |
Covid Analysis (Preprint) (meta analysis) |
• Statistically significant improvements are seen for mortality, hospitalization, and cases. 5 studies from 5 independent teams in 2 different countries show statistically significant improvements in isolation (3 for the most serious outcome).• Meta analysis using the most serious outcome reported shows 46% [17‑64%] improvement. Results are slightly worse for Randomized Controlled Trials and similar for peer-reviewed studies. • Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2 [Zhou], however [Kertes] show significant efficacy with omicron. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape [Choudhary]. • While many treatments have some level of efficacy, they do not replace vaccines and other measures to avoid infection. Only 17% of tixagevimab/cilgavimab studies show zero events in the treatment arm. Multiple treatments are typically used in combination, and other treatments may be more effective.• No treatment, vaccine, or intervention is 100% available and effective for all variants. All practical, effective, and safe means should be used. Denying the efficacy of treatments increases mortality, morbidity, collateral damage, and endemic risk.• All data to reproduce this paper and sources are in the appendix.
Covid Analysis et al., 8/12/2022, preprint, 1 author.
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PrEPPEP |
Kertes et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac625 |
death/hosp., ↓91.9%, p=0.01 |
Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality |
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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. |
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Prophylaxis study
Prophylaxis study
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Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality |
Kertes et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac625 |
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.
risk of death/hospitalization, 91.9% lower, RR 0.08, p = 0.01, treatment 1 of 825 (0.1%), control 63 of 4,299 (1.5%), NNT 74, adjusted, OR converted to RR, multivariable.
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risk of case, 47.1% lower, RR 0.53, p = 0.01, treatment 29 of 825 (3.5%), control 308 of 4,299 (7.2%), NNT 27, adjusted, OR converted to RR, multivariable.
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Kertes et al., 7/29/2022, retrospective, Israel, peer-reviewed, 10 authors.
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Late |
Holland et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00215-6 |
death, ↓30.0%, p=0.03 |
Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial |
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RCT with 710 hospitalized patients treated with tixagevimab/cilgavimab, and 707 placebo patients, showing lower mortality with treatment. |
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Late treatment study
Late treatment study
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Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial |
Holland et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00215-6 |
RCT with 710 hospitalized patients treated with tixagevimab/cilgavimab, and 707 placebo patients, showing lower mortality with treatment.
risk of death, 30.0% lower, RR 0.70, p = 0.03, treatment 61 of 710 (8.6%), control 86 of 707 (12.2%), NNT 28, day 90.
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risk of no recovery, 7.4% lower, RR 0.93, p = 0.21, treatment 710, control 707, sustained recovery, day 90, primary outcome.
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Holland et al., 7/8/2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 103 authors, study period 10 February, 2021 - 30 September, 2021, trial NCT04501978 (history) (ACTIV-3-TICO).
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Early |
Montgomery et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00180-1 |
death, ↓0.2%, p=1.00 |
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 |
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RCT 910 outpatients in the USA, 456 treated with tixagevimab/cilgavimab, showing significantly lower combined severe COVID-19/death with treatment. |
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Early treatment study
Early treatment study
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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 |
Montgomery et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00180-1 |
RCT 910 outpatients in the USA, 456 treated with tixagevimab/cilgavimab, showing significantly lower combined severe COVID-19/death with treatment.
risk of death, 0.2% lower, RR 1.00, p = 1.00, treatment 6 of 452 (1.3%), control 6 of 451 (1.3%), NNT 33975, all cause mortality.
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risk of severe case, 50.4% lower, RR 0.50, p = 0.010, treatment 18 of 407 (4.4%), control 37 of 415 (8.9%), NNT 22, primary outcome.
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risk of hospitalization, 56.7% lower, RR 0.43, p = 0.002, treatment 17 of 413 (4.1%), control 40 of 421 (9.5%), NNT 19.
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Montgomery et al., 6/7/2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, mean age 46.0, 20 authors, study period 28 January, 2021 - 22 July, 2021, trial NCT04723394 (history) (TACKLE).
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PrEPPEP |
Young-Xu et al., medRxiv, doi:10.1101/2022.05.28.22275716 (Preprint) |
death, ↓64.0%, p=0.004 |
Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA Electronic Data |
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PSM retrospective 1,848 immunocompromised patients given tixagevimab/cilgavimab prophylaxis, showing lower mortality, hospitalization, and cases. |
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Prophylaxis study
Prophylaxis study
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Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA Electronic Data |
Young-Xu et al., medRxiv, doi:10.1101/2022.05.28.22275716 (Preprint) |
PSM retrospective 1,848 immunocompromised patients given tixagevimab/cilgavimab prophylaxis, showing lower mortality, hospitalization, and cases.
risk of death, 64.0% lower, HR 0.36, p = 0.004, treatment 1,733, control 6,354.
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risk of death/hospitalization/cases, 69.0% lower, HR 0.31, p < 0.001, treatment 17 of 1,733 (1.0%), control 206 of 6,354 (3.2%), NNT 44.
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risk of hospitalization, 87.0% lower, HR 0.13, p = 0.04, treatment 1,733, control 6,354.
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risk of case, 66.0% lower, HR 0.34, p = 0.03, treatment 1,733, control 6,354.
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Young-Xu et al., 5/29/2022, retrospective, propensity score matching, USA, preprint, 10 authors.
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PrEPPEP |
Levin et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116620 |
death, ↓85.7%, p=0.11 |
Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19 |
Details
PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment. |
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Prophylaxis study
Prophylaxis study
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Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19 |
Levin et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116620 |
PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment.
risk of death, 85.7% lower, RR 0.14, p = 0.11, treatment 0 of 3,441 (0.0%), control 2 of 1,731 (0.1%), NNT 866, relative risk is not 0 because of continuity correction due to zero events.
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risk of symptomatic case, 82.1% lower, RR 0.18, p < 0.001, treatment 11 of 3,441 (0.3%), control 31 of 1,731 (1.8%), NNT 68, 6 months.
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risk of symptomatic case, 76.3% lower, RR 0.24, p < 0.001, treatment 8 of 3,441 (0.2%), control 17 of 1,731 (1.0%), NNT 133, median 83 days followup.
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Levin et al., 4/20/2022, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 24 authors, study period 21 November, 2020 - 22 March, 2021, trial NCT04625725 (history) (PROVENT).
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PrEPPEP |
FDA (Preprint) |
symp. case, ↓39.5%, p=0.07 |
Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) |
Details
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. |
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Prophylaxis study
Prophylaxis study
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Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) |
FDA (Preprint) |
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.
risk of symptomatic case, 39.5% lower, RR 0.60, p = 0.07, treatment 28 of 749 (3.7%), control 23 of 372 (6.2%), NNT 41, from graph, day 180.
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risk of symptomatic case, 32.8% lower, RR 0.67, p = 0.23, treatment 23 of 749 (3.1%), control 17 of 372 (4.6%), NNT 67.
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FDA et al., 12/8/2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, preprint, 1 author, trial NCT04625972 (history).
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PrEPPEP |
Levin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1646 (Preprint) |
death, ↓85.7%, p=0.11 |
PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults |
Details
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 . |
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Prophylaxis study
Prophylaxis study
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PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults |
Levin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1646 (Preprint) |
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].
risk of death, 85.7% lower, RR 0.14, p = 0.11, treatment 0 of 3,441 (0.0%), control 2 of 1,731 (0.1%), NNT 866, relative risk is not 0 because of continuity correction due to zero events.
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risk of symptomatic case, 76.3% lower, RR 0.24, p < 0.001, treatment 8 of 3,441 (0.2%), control 17 of 1,731 (1.0%), NNT 133.
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Levin et al., 12/8/2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, preprint, 19 authors, trial NCT04625725 (history) (PROVENT).
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Submit Corrections or Comments
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