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Early, Late, PrEP, PEP |
Covid Analysis (Preprint) (meta analysis) |
meta-analysis |
Bamlanivimab/etesevimab for COVID-19: real-time meta analysis of 14 studies |
Details
• Statistically significant improvements are seen for mortality, ICU admission, hospitalization, recovery, and cases. 11 studies from 9 independent teams (all from the same country) show statistically significant improvements in isolation.. |
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Early, Late, PrEP, PEP
Early, Late, PrEP, PEP
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Bamlanivimab/etesevimab for COVID-19: real-time meta analysis of 14 studies |
Covid Analysis (Preprint) (meta analysis) |
• Statistically significant improvements are seen for mortality, ICU admission, hospitalization, recovery, and cases. 11 studies from 9 independent teams (all from the same country) show statistically significant improvements in isolation (4 for the most serious outcome).• Meta analysis using the most serious outcome reported shows 55% [30‑71%] improvement. Results are similar for Randomized Controlled Trials, similar after exclusions, and similar for peer-reviewed studies. Early treatment is more effective than late treatment. • Results are robust — in exclusion sensitivity analysis 6 of 14 studies must be excluded to avoid finding statistically significant efficacy in pooled analysis.• Efficacy is highly variant dependent. In Vitro studies suggest a lack of efficacy for omicron [Liu, Sheward, VanBlargan]. 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 7% of bamlanivimab/etesevimab 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., 6/27/2022, preprint, 1 author.
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Early |
Wilden et al., Journal of the National Comprehensive Cancer Network, doi:10.6004/jnccn.2021.7309 |
hosp., ↓51.0%, p=0.06 |
Real World Outcomes of Cancer Patients With SARS-CoV-2 Infection Receiving Monoclonal Antibodies |
Details
Retrospective 395 patients in the USA receiving casirivimab/imdevimab or bamlanivimab, showing lower risk of hospitalization with treatment, statistically significant for casirivimab/imdevimab. |
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Early treatment study
Early treatment study
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Real World Outcomes of Cancer Patients With SARS-CoV-2 Infection Receiving Monoclonal Antibodies |
Wilden et al., Journal of the National Comprehensive Cancer Network, doi:10.6004/jnccn.2021.7309 |
Retrospective 395 patients in the USA receiving casirivimab/imdevimab or bamlanivimab, showing lower risk of hospitalization with treatment, statistically significant for casirivimab/imdevimab.
risk of hospitalization, 51.0% lower, OR 0.49, p = 0.06, adjusted, multivariable, RR approximated with OR.
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Wilden et al., 3/31/2022, retrospective, USA, North America, peer-reviewed, 9 authors, study period December 2020 - July 2021.
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In Vitro |
Zhou et al., bioRxiv, doi:10.1101/2022.02.15.480166 (Preprint) (In Vitro) |
In Vitro |
SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies |
Details
In Vitro study showing that omicron BA.2 evades all monoclonal antibodies tested, including sotrovimab and tixagevimab/cilgavimab which retained activity for omicron BA.1. |
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In Vitro
In Vitro
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SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies |
Zhou et al., bioRxiv, doi:10.1101/2022.02.15.480166 (Preprint) (In Vitro) |
In Vitro study showing that omicron BA.2 evades all monoclonal antibodies tested, including sotrovimab and tixagevimab/cilgavimab which retained activity for omicron BA.1.
Zhou et al., 2/16/2022, preprint, 4 authors.
In Vitro studies are an important part of preclinical research, however results may be very different in vivo.
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Early |
Dale et al., Journal of the American Geriatrics Society, doi:10.1111/jgs.17705 |
death, ↓89.2%, p=0.010 |
Clinical Outcomes of Monoclonal Antibody Therapy During a COVID ‐19 Outbreak in a Skilled Nursing Facility‐Arizona, 2021 |
Details
Retrospective 75 COVID+ patients in a skilled nursing facility in the USA, 56 treated within a median of 2 days from symptom onset with bamlanivimab, showing significantly lower mortality with treatment. |
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Early treatment study
Early treatment study
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Clinical Outcomes of Monoclonal Antibody Therapy During a COVID ‐19 Outbreak in a Skilled Nursing Facility‐Arizona, 2021 |
Dale et al., Journal of the American Geriatrics Society, doi:10.1111/jgs.17705 |
Retrospective 75 COVID+ patients in a skilled nursing facility in the USA, 56 treated within a median of 2 days from symptom onset with bamlanivimab, showing significantly lower mortality with treatment.
risk of death, 89.2% lower, RR 0.11, p = 0.010, treatment 5 of 56 (8.9%), control 9 of 19 (47.4%), NNT 2.6, adjusted, OR converted to RR, multivariable.
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risk of progression, 86.3% lower, RR 0.14, p = 0.002, treatment 6 of 56 (10.7%), control 10 of 19 (52.6%), NNT 2.4, adjusted, OR converted to RR, oxygen therapy, multivariable.
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risk of progression, 53.8% lower, RR 0.46, p = 0.35, treatment 6 of 56 (10.7%), control 3 of 19 (15.8%), adjusted, OR converted to RR, ER visit or hospitalization, multivariable.
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Dale et al., 2/9/2022, retrospective, USA, North America, peer-reviewed, 14 authors, average treatment delay 2.0 days.
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Early |
Delasobera et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001109 |
death, ↑119.4%, p=0.64 |
Impact of Rapidly Deployed COVID-19 Monoclonal Antibody Infusion Clinics on Rate of Hospitalization |
Details
Retrospective 438 patients in the USA, 253 treated with bamlanivimab, showing significantly lower hospitalization with treatment. |
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Early treatment study
Early treatment study
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Impact of Rapidly Deployed COVID-19 Monoclonal Antibody Infusion Clinics on Rate of Hospitalization |
Delasobera et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001109 |
Retrospective 438 patients in the USA, 253 treated with bamlanivimab, showing significantly lower hospitalization with treatment.
risk of death, 119.4% higher, RR 2.19, p = 0.64, treatment 3 of 253 (1.2%), control 1 of 185 (0.5%).
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risk of hospitalization, 52.2% lower, RR 0.48, p = 0.01, treatment 17 of 253 (6.7%), control 26 of 185 (14.1%), NNT 14.
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risk of progression, 19.9% lower, RR 0.80, p = 0.52, treatment 23 of 253 (9.1%), control 21 of 185 (11.4%), NNT 44, ER followup visit.
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Delasobera et al., 1/27/2022, retrospective, USA, North America, peer-reviewed, 12 authors.
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Late |
Priest et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001130 |
death, 0.0%, p=1.00 |
Bamlanivimab for the Prevention of Hospitalizations and Emergency Department Visits in SARS-CoV-2–Positive Patients in a Regional Health Care System |
Details
Retrospective 379 bamlanivimab patients and 379 matched controls in the USA, showing no significant differences with treatment. |
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Late treatment study
Late treatment study
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Bamlanivimab for the Prevention of Hospitalizations and Emergency Department Visits in SARS-CoV-2–Positive Patients in a Regional Health Care System |
Priest et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001130 |
Retrospective 379 bamlanivimab patients and 379 matched controls in the USA, showing no significant differences with treatment.
risk of death, no change, RR 1.00, p = 1.00, treatment 6 of 379 (1.6%), control 6 of 379 (1.6%).
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risk of hospitalization, 3.9% higher, RR 1.04, p = 0.86, treatment 79 of 379 (20.8%), control 76 of 379 (20.1%), all-cause hospital revisit.
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risk of hospitalization/ER, 5.0% higher, OR 1.05, p = 0.86, treatment 379, control 379, RR approximated with OR.
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Priest et al., 1/27/2022, retrospective, propensity score matching, USA, North America, peer-reviewed, 5 authors, study period October 2020 - March 2021, average treatment delay 6.0 days.
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Late |
Chew et al., medRxiv, doi:10.1101/2021.12.17.21268009 (Preprint) |
hosp., ↓25.5%, p=0.60 |
Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19 |
Details
RCT 317 outpatients in the USA showing faster viral load and inflammatory biomarker decline, but no significant differences in clinical outcomes. ACTIV-2/A5401. NCT04518410. Supplementary data is not currently available. |
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Late treatment study
Late treatment study
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Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19 |
Chew et al., medRxiv, doi:10.1101/2021.12.17.21268009 (Preprint) |
RCT 317 outpatients in the USA showing faster viral load and inflammatory biomarker decline, but no significant differences in clinical outcomes. ACTIV-2/A5401. NCT04518410. Supplementary data is not currently available.
risk of hospitalization, 25.5% lower, RR 0.75, p = 0.60, treatment 6 of 159 (3.8%), control 8 of 158 (5.1%), NNT 78, combined.
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risk of hospitalization, 52.1% lower, RR 0.48, p = 0.43, treatment 2 of 48 (4.2%), control 4 of 46 (8.7%), NNT 22, 7000mg, day 28.
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risk of hospitalization, 0.9% higher, RR 1.01, p = 1.00, treatment 4 of 111 (3.6%), control 4 of 112 (3.6%), 700mg, day 28.
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relative time to symptom improvement, 13.5% higher, relative time 1.14, p = 0.97, treatment 48, control 46, 7000mg, primary outcome.
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relative time to symptom improvement, 17.1% higher, relative time 1.17, p = 0.08, treatment 111, control 112, 700mg, primary outcome.
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viral load, 25.6% lower, relative load 0.74, p = 0.002, treatment 48, control 46, 7000mg, day 3.
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viral load, 35.3% lower, relative load 0.65, p = 0.07, treatment 111, control 112, 700mg, day 3.
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Chew et al., 12/21/2021, Randomized Controlled Trial, USA, North America, preprint, 23 authors, study period 19 August, 2020 - 17 November, 2020, average treatment delay 6.0 days, trial NCT04518410.
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In Vitro |
Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354 (Preprint) (In Vitro) |
In Vitro |
Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron) |
Details
In Vitro study showing that omicron is substantially resistant to neutralization by monoclonal antibodies REGN10933, REGN10987, Ly-CoV016 and Ly-CoV555. S309 (the parent of Sotrovimab) had only 2-fold loss in potency. |
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In Vitro
In Vitro
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Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron) |
Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354 (Preprint) (In Vitro) |
In Vitro study showing that omicron is substantially resistant to neutralization by monoclonal antibodies REGN10933, REGN10987, Ly-CoV016 and Ly-CoV555. S309 (the parent of Sotrovimab) had only 2-fold loss in potency.
Sheward et al., 12/20/2021, preprint, 11 authors.
In Vitro studies are an important part of preclinical research, however results may be very different in vivo.
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In Vitro |
VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828 (Preprint) (In Vitro) |
In Vitro |
An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies |
Details
In vitro study (Vero-TMPRSS2 and Vero-hACE2-TMPRSS2) showing complete loss of inhibitory activity for B.1.1.529 omicron with LY-CoV555, LY-CoV016, REGN10933, REGN10987, and CT-P59, ~12-fold decrease for COV2-2196/COV2-2130, and minimal ch.. |
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In Vitro
In Vitro
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An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies |
VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828 (Preprint) (In Vitro) |
In vitro study (Vero-TMPRSS2 and Vero-hACE2-TMPRSS2) showing complete loss of inhibitory activity for B.1.1.529 omicron with LY-CoV555, LY-CoV016, REGN10933, REGN10987, and CT-P59, ~12-fold decrease for COV2-2196/COV2-2130, and minimal change for S309.
VanBlargan et al., 12/17/2021, preprint, 10 authors.
In Vitro studies are an important part of preclinical research, however results may be very different in vivo.
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Submit Corrections or Comments
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In Vitro |
Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719 (Preprint) (In Vitro) |
In Vitro |
Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2 |
Details
In vitro study (Vero-E6-TMPRSS2) showing 18 of 19 monoclonal antibodies were no longer effective or significantly impaired with B.1.1.529 omicron. |
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In Vitro
In Vitro
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Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2 |
Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719 (Preprint) (In Vitro) |
In vitro study (Vero-E6-TMPRSS2) showing 18 of 19 monoclonal antibodies were no longer effective or significantly impaired with B.1.1.529 omicron.
Liu et al., 12/15/2021, preprint, 23 authors.
In Vitro studies are an important part of preclinical research, however results may be very different in vivo.
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Submit Corrections or Comments
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Early |
Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546 |
death, ↓44.2%, p=1.00 |
Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process |
Details
Retrospective database analysis of 1257 PCR+ outpatients with age ≥65, BMI≥35, 191 receiving bamlanivimab via lottery. Authors note that the alpha variant was most common during the study period, and that efficacy against other variants c.. |
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Early treatment study
Early treatment study
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Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process |
Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546 |
Retrospective database analysis of 1257 PCR+ outpatients with age ≥65, BMI≥35, 191 receiving bamlanivimab via lottery. Authors note that the alpha variant was most common during the study period, and that efficacy against other variants can be much lower. Authors note confounding due to prioritization in the lottery and differential reporting in the database.
risk of death, 44.2% lower, RR 0.56, p = 1.00, treatment 1 of 191 (0.5%), control 10 of 1,066 (0.9%), NNT 241.
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risk of hospitalization, 65.3% lower, RR 0.35, p = 0.04, treatment 16 of 191 (8.4%), control 121 of 1,065 (11.4%), OR converted to RR, IPTW weighted logistic regression.
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Excluded in after exclusion results of meta analysis:
significant unadjusted confounding possible.
Conflicts of interest:
research funding from the drug patent holder, consulting for the pharmaceutical industry.
Rubin et al., 11/3/2021, retrospective, USA, North America, peer-reviewed, 7 authors, study period 9 December, 2020 - 25 February, 2021, average treatment delay 6.0 days.
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N/A |
Kaleta et al., Research Square, doi:10.21203/rs.3.rs-995033/v1 (Preprint) |
Antibody escape and global spread of SARS-CoV-2 lineage A.27 |
Details
Anaysis of antibody escape showing variant A.27 completely escaped neutralization with LY-COV555 and partially with REGN10987. B.1.617.2 escaped these antibodies in a similar manner, suggesting that L452R facilitates the escape. Authors n.. |
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N/A
N/A
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Antibody escape and global spread of SARS-CoV-2 lineage A.27 |
Kaleta et al., Research Square, doi:10.21203/rs.3.rs-995033/v1 (Preprint) |
Anaysis of antibody escape showing variant A.27 completely escaped neutralization with LY-COV555 and partially with REGN10987. B.1.617.2 escaped these antibodies in a similar manner, suggesting that L452R facilitates the escape. Authors note that B.1.351 and P.1 escaped LY-COV555 and REGN10933, likely facilitated by the E484K mutation, suggesting that L452R and E484K lead to escape from LY-COV555 and to partial resistance to either REGN10987 or REGN10933, respectively.
Kaleta et al., 11/2/2021, preprint, 33 authors.
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Early |
Schiaroli et al., Mediterranean Journal of Hematology and Infectious Diseases, doi:10.4084/MJHID.2021.061 |
Early Treatment with BamlanivimabAlone does not Prevent COVID-19 Hospitalization and Its Post-Acute Sequelae. A Real Experience in Umbria, Italy |
Details
Retrospective 39 patients treated with bamlanivimab in Italy, showing results far below expectations based on the BLAZE1 trial. Authors note that most patients had the alpha variant which does not have the E484K and L452R mutations known .. |
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Early treatment study
Early treatment study
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Early Treatment with BamlanivimabAlone does not Prevent COVID-19 Hospitalization and Its Post-Acute Sequelae. A Real Experience in Umbria, Italy |
Schiaroli et al., Mediterranean Journal of Hematology and Infectious Diseases, doi:10.4084/MJHID.2021.061 |
Retrospective 39 patients treated with bamlanivimab in Italy, showing results far below expectations based on the BLAZE1 trial. Authors note that most patients had the alpha variant which does not have the E484K and L452R mutations known to lead to resistance.
Schiaroli et al., 10/29/2021, retrospective, Italy, Europe, peer-reviewed, 7 authors.
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Early |
Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512 |
death, ↓45.3%, p=1.00 |
Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study |
Details
Retrospective 2,879 patients and matched controls in the USA, showing significantly lower mortality and hospitalization with bamlanivimab, bamlanivimab/etesevimab, and casirivimab/imdevimab. There was significantly lower hospitalization w.. |
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Early treatment study
Early treatment study
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Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study |
Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512 |
Retrospective 2,879 patients and matched controls in the USA, showing significantly lower mortality and hospitalization with bamlanivimab, bamlanivimab/etesevimab, and casirivimab/imdevimab. There was significantly lower hospitalization with casirivimab/imdevimab compared to bamlanivimab or bamlanivimab/etesevimab. PSM and multivariate analysis is only provided for all treatments combined.
risk of death, 45.3% lower, RR 0.55, p = 1.00, treatment 1 of 473 (0.2%), control 33 of 8,534 (0.4%), NNT 571, unadjusted, bamlanivimab-etesevimab.
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risk of ICU admission, 57.5% lower, RR 0.42, p = 0.33, treatment 2 of 473 (0.4%), control 85 of 8,534 (1.0%), NNT 174, unadjusted, bamlanivimab-etesevimab.
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risk of hospitalization, 5.0% lower, RR 0.95, p = 0.86, treatment 37 of 473 (7.8%), control 703 of 8,534 (8.2%), NNT 241, unadjusted, bamlanivimab-etesevimab, primary outcome.
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risk of death, 17.2% higher, RR 1.17, p = 0.59, treatment 11 of 2,427 (0.5%), control 33 of 8,534 (0.4%), unadjusted, bamlanivimab.
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risk of ICU admission, 9.0% lower, RR 0.91, p = 0.81, treatment 22 of 2,427 (0.9%), control 85 of 8,534 (1.0%), NNT 1117, unadjusted, bamlanivimab.
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risk of hospitalization, 28.0% lower, RR 0.72, p < 0.001, treatment 144 of 2,427 (5.9%), control 703 of 8,534 (8.2%), NNT 43, unadjusted, bamlanivimab.
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Excluded in after exclusion results of meta analysis:
unadjusted results with no group details.
Cooper et al., 10/8/2021, retrospective, USA, North America, peer-reviewed, 9 authors.
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Early |
Dougan et al., New England Journal of Medicine, doi:10.1056/NEJMoa2102685 |
death, ↓94.7%, p=0.002 |
Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19 |
Details
Results from the BLAZE-1 RCT of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. NCT04427501. |
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Early treatment study
Early treatment study
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Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19 |
Dougan et al., New England Journal of Medicine, doi:10.1056/NEJMoa2102685 |
Results from the BLAZE-1 RCT of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. NCT04427501.
risk of death, 94.7% lower, RR 0.05, p = 0.002, treatment 0 of 518 (0.0%), control 9 of 517 (1.7%), NNT 57, relative risk is not 0 because of continuity correction due to zero events, COVID-19 deaths.
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risk of death/hospitalization, 69.5% lower, RR 0.30, p < 0.001, treatment 11 of 518 (2.1%), control 36 of 517 (7.0%), NNT 21, primary outcome.
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recovery time, 11.1% lower, relative time 0.89, p = 0.007, treatment 518, control 517, sustained resolution of symptoms.
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risk of no viral clearance, 66.6% lower, RR 0.33, p < 0.001, treatment 50 of 508 (9.8%), control 147 of 499 (29.5%), NNT 5.1, day 7, persistently high viral load.
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Dougan et al., 10/7/2021, Double Blind Randomized Controlled Trial, USA, North America, peer-reviewed, 33 authors, average treatment delay 4.0 days, trial NCT04427501.
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Submit Corrections or Comments
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Late |
Ganesh et al., Journal of Clinical Investigation, doi:10.1172/JCI151697 |
death, ↓74.4%, p=0.11 |
Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19 |
Details
Retrospective 2,335 bamlanivimab patients and 2,335 PSM controls in the USA, showing significantly lower hospitalization with treatment. |
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Late treatment study
Late treatment study
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Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19 |
Ganesh et al., Journal of Clinical Investigation, doi:10.1172/JCI151697 |
Retrospective 2,335 bamlanivimab patients and 2,335 PSM controls in the USA, showing significantly lower hospitalization with treatment.
risk of death, 74.4% lower, RR 0.26, p = 0.11, treatment 2 of 1,789 (0.1%), control 8 of 1,832 (0.4%), NNT 308, day 28.
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risk of ICU admission, 48.8% lower, RR 0.51, p = 0.10, treatment 10 of 1,789 (0.6%), control 20 of 1,832 (1.1%), NNT 188, day 28.
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risk of hospitalization, 37.4% lower, RR 0.63, p = 0.01, treatment 44 of 1,789 (2.5%), control 72 of 1,832 (3.9%), NNT 68, day 28, primary outcome.
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Ganesh et al., 10/1/2021, retrospective, USA, North America, peer-reviewed, median age 63.0, 20 authors.
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Submit Corrections or Comments
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Late |
Choudhary et al., medRxiv, doi:10.1101/2021.09.03.21263105 (Preprint) |
Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy |
Details
Analysis of ACTIV-2/A5401, showing the potential for rapid emergence of resistance during monoclonal antibody treatment, resulting in prolonged high level viral loads and clinical worsening. Treatment-emergent resistance mutations were mo.. |
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Late treatment study
Late treatment study
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Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy |
Choudhary et al., medRxiv, doi:10.1101/2021.09.03.21263105 (Preprint) |
Analysis of ACTIV-2/A5401, showing the potential for rapid emergence of resistance during monoclonal antibody treatment, resulting in prolonged high level viral loads and clinical worsening. Treatment-emergent resistance mutations were more common after bamlanivimab 700mg (7% of 111 vs 0% of 112 participants, p=0.003). NCT04518410.
Choudhary et al., 9/15/2021, preprint, 28 authors, trial NCT04518410.
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Early |
Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331 |
death, ↓79.7%, p=0.09 |
Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19 |
Details
Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors incorrectly state that "no other COVID-19 therapies for ambulatory patients hav.. |
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Early treatment study
Early treatment study
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Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19 |
Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331 |
Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors incorrectly state that "no other COVID-19 therapies for ambulatory patients have proven effective".
risk of death, 79.7% lower, RR 0.20, p = 0.09, treatment 1 of 479 (0.2%), control 57 of 5,536 (1.0%), NNT 122.
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risk of hospitalization, 52.7% lower, RR 0.47, p < 0.001, treatment 22 of 479 (4.6%), control 538 of 5,536 (9.7%), NNT 20.
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risk of hospitalization/ER, 26.8% lower, RR 0.73, p < 0.001, treatment 65 of 479 (13.6%), control 1,018 of 5,536 (18.4%), NNT 21, OR converted to RR, primary outcome.
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Webb et al., 6/23/2021, retrospective, USA, North America, peer-reviewed, 14 authors.
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N/A |
Focosi et al., Research Square, doi:10.21203/rs.3.rs-524959/v1 (Preprint) |
Emergence of SARS-CoV-2 Spike Escape Mutation Q493r After Bamlanivimab/Etesevimab Treatment for COVID-19 |
Details
Case study showing that a mutation resistant to both bamlanivimab and etesevimab can arise in vivo. Authors note that accelerated evolution can occur under selective pressure from therapeutic interventions with neutralizing antibodies, an.. |
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N/A
N/A
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Emergence of SARS-CoV-2 Spike Escape Mutation Q493r After Bamlanivimab/Etesevimab Treatment for COVID-19 |
Focosi et al., Research Square, doi:10.21203/rs.3.rs-524959/v1 (Preprint) |
Case study showing that a mutation resistant to both bamlanivimab and etesevimab can arise in vivo. Authors note that accelerated evolution can occur under selective pressure from therapeutic interventions with neutralizing antibodies, and that bamlanivimab was withdrawn as a monotherapy because of failure against E484K-positive SARS-CoV-2 variants.
Focosi et al., 5/18/2021, preprint, 7 authors.
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Late |
Bariola et al., medRxiv, doi:10.1101/2021.03.25.21254322 (Preprint) |
death, ↓66.8%, p=0.05 |
Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection |
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Retrospective 234 patients receiving bamlanivimab and 234 matched controls, showing lower hospitalization and mortality with treatment. Greater benefit was seen with administration within 4 days of their positive COVID-19 test. |
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Late treatment study
Late treatment study
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Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection |
Bariola et al., medRxiv, doi:10.1101/2021.03.25.21254322 (Preprint) |
Retrospective 234 patients receiving bamlanivimab and 234 matched controls, showing lower hospitalization and mortality with treatment. Greater benefit was seen with administration within 4 days of their positive COVID-19 test.
risk of death, 66.8% lower, RR 0.33, p = 0.05, treatment 4 of 234 (1.7%), control 12 of 234 (5.1%), NNT 29, OR converted to RR.
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risk of death/hospitalization, 64.3% lower, RR 0.36, p < 0.001, treatment 16 of 234 (6.8%), control 45 of 234 (19.2%), NNT 8.1, OR converted to RR, primary outcome.
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risk of hospitalization, 60.7% lower, RR 0.39, p = 0.001, treatment 15 of 234 (6.4%), control 39 of 234 (16.7%), NNT 9.8, OR converted to RR.
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Bariola et al., 3/30/2021, retrospective, USA, North America, preprint, 22 authors.
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PrEPPEP |
Lilly, Press Release (Preprint) |
symp. case, ↓57.0%, p=0.0002 |
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents |
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Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment. |
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Prophylaxis study
Prophylaxis study
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Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents |
Lilly, Press Release (Preprint) |
Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment.
risk of symptomatic case, 57.0% lower, RR 0.43, p < 0.001, treatment 483, control 482, group sizes estimated because they were not supplied.
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risk of symptomatic case, 80.0% lower, RR 0.20, p < 0.001, treatment 150, control 149, nursing home residents, group sizes estimated because they were not supplied.
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Lilly et al., 1/21/2021, Randomized Controlled Trial, USA, North America, preprint, 1 author.
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Early |
Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 |
hosp./ER, ↓70.6%, p=0.046 |
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 |
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RCT for LY-CoV555 monotherapy and LY-CoV555/LY-CoV016 combination therapy with 592 patients showing lower hospitalization/ER visits with treatment. For viral load at day 11, a statistically significant reduction was found with combination.. |
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Early treatment study
Early treatment study
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Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 |
Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 |
RCT for LY-CoV555 monotherapy and LY-CoV555/LY-CoV016 combination therapy with 592 patients showing lower hospitalization/ER visits with treatment.For viral load at day 11, a statistically significant reduction was found with combination therapy but not monotherapy.
risk of hospitalization/ER, 70.6% lower, RR 0.29, p = 0.046, treatment 4 of 101 (4.0%), control 7 of 52 (13.5%), NNT 11, LY-CoV555 all dosages.
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risk of hospitalization/ER, 79.9% lower, RR 0.20, p = 0.13, treatment 1 of 37 (2.7%), control 7 of 52 (13.5%), NNT 9.3, LY-CoV555 700mg.
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risk of hospitalization/ER, 75.2% lower, RR 0.25, p = 0.25, treatment 1 of 30 (3.3%), control 7 of 52 (13.5%), NNT 9.9, LY-CoV555 2800mg.
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risk of hospitalization/ER, 56.3% lower, RR 0.44, p = 0.31, treatment 2 of 34 (5.9%), control 7 of 52 (13.5%), NNT 13, LY-CoV555 7000mg.
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risk of hospitalization/ER, 91.8% lower, RR 0.08, p = 0.04, treatment 0 of 31 (0.0%), control 7 of 52 (13.5%), NNT 7.4, relative risk is not 0 because of continuity correction due to zero events, LY-CoV555/LY-CoV016.
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Gottlieb et al., 1/21/2021, Randomized Controlled Trial, USA, North America, peer-reviewed, 27 authors, average treatment delay 4.0 days.
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Late |
ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 |
death, ↑100%, p=0.22 |
A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 |
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Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555. NCT04501978. |
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Late treatment study
Late treatment study
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A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 |
ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 |
Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555. NCT04501978.
risk of death, 100% higher, HR 2.00, p = 0.22, treatment 9 of 163 (5.5%), control 5 of 151 (3.3%), adjusted, proportional hazards regression.
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ACTIV-3/TICO et al., 12/22/2020, Randomized Controlled Trial, USA, North America, peer-reviewed, 1 author, average treatment delay 7.0 days, trial NCT04501978.
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Early |
Chen et al., NEJM, doi:10.1056/NEJMoa2029849 |
hosp., ↓74.3%, p=0.02 |
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 |
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Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo. NCT04427501. |
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Early treatment study
Early treatment study
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SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 |
Chen et al., NEJM, doi:10.1056/NEJMoa2029849 |
Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo. NCT04427501.
risk of hospitalization, 74.3% lower, RR 0.26, p = 0.02, treatment 5 of 309 (1.6%), control 9 of 143 (6.3%), NNT 21.
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Chen et al., 10/28/2020, Randomized Controlled Trial, USA, North America, peer-reviewed, 12 authors, average treatment delay 4.0 days, trial NCT04427501.
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News |
Lilly, Press Release (News) |
news |
Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial |
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ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing. |
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News
News
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Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial |
Lilly, Press Release (News) |
ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing.
Lilly et al., 10/26/2020, preprint, 1 author.
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Early |
Lilly, Press Release (Preprint) |
hosp., ↓84.5%, p=0.049 |
SARS-CoV-2 neutralizing antibody program update |
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Interim results from the BLAZE-1 outpatient RCT showing improvements in viral load, symptoms and hospitalization. Combination therapy significantly reduced viral load at day 11 (p=0.011). A greater effect is seen at day 7 (p<0.001). The p.. |
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Early treatment study
Early treatment study
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SARS-CoV-2 neutralizing antibody program update |
Lilly, Press Release (Preprint) |
Interim results from the BLAZE-1 outpatient RCT showing improvements in viral load, symptoms and hospitalization.Combination therapy significantly reduced viral load at day 11 (p=0.011). A greater effect is seen at day 7 (p<0.001). The proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3.0 percent) versus placebo (20.8 percent), corresponding to a nominal p value of p<0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed thus far in patients treated with combination therapy.The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9 percent) versus placebo (5.8 percent), a relative risk reduction of 84.5 percent (p=0.049). This was also similar to observations for LY-CoV555 monotherapy.Combination therapy has been generally well tolerated with no drug-related serious adverse events. In LY-CoV555 monotherapy studies there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, all patients recovered).NCT04427501
risk of hospitalization or ER visit, 84.5% lower, RR 0.15, p = 0.049, treatment 112, control 156.
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Lilly et al., 10/7/2020, Randomized Controlled Trial, USA, North America, preprint, 1 author, trial NCT04427501.
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