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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 2 studies |
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• Meta analysis using the most serious outcome reported shows 42% [2‑66%] improvement. Results are better for peer-reviewed studies. • One study shows statistically significant improvement in isolation (not for the most serious.. |
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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 2 studies |
| Covid Analysis (Preprint) (meta analysis) |
• Meta analysis using the most serious outcome reported shows 42% [2‑66%] improvement. Results are better for peer-reviewed studies. • One study shows statistically significant improvement in isolation (not for the most serious outcome).• Currently there is limited data, with only 25 control events for the most serious outcome in trials to date.• Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2 [Zhou]. 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 50% 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. There has been no early treatment studies to date.• 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.
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Covid Analysis et al., 5/20/2022, preprint, 1 author.
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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 |
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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 |
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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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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, multiple regions, peer-reviewed, 24 authors, study period 21 November, 2020 - 22 March, 2021, trial NCT04625725 (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) |
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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) |
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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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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, multiple regions, preprint, 1 author, trial NCT04625972. |
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Submit Corrections or Comments
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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 |
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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 . PROVENT. NCT04625725. |
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Details
Source
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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) |
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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]. PROVENT. NCT04625725.
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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, multiple regions, preprint, 19 authors, trial NCT04625725. |
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Submit Corrections or Comments
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