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Casirivimab/imdevimab COVID-19 studies. Efficacy is variant dependent. In Vitro studies suggest a lack of efficacy for omicron [Liu, Sheward, Tatham, VanBlargan]. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape [Choudhary]. Recent:
Kneidinger
Williams
Levey
Kadowaki
Miyashita.
Casirivimab/imdevimab has been officially adopted for early treatment in 16 countries. Submit updates/corrections.
Sep 29
Early, Late, PrEP, PEP Covid Analysis (Preprint) (meta analysis)
meta-analysis
Casirivimab/imdevimab for COVID-19: real-time meta analysis of 24 studies
Details   • Statistically significant improvements are seen for mortality, hospitalization, progression, recovery, cases, and viral clearance. 17 studies from 12 independent teams in 4 different countries show statistically significant improvements..
Sep 12
Early Williams et al., American Journal of Obstetrics and Gynecology, doi:10.1016/j.ajog.2022.09.017
oxygen, ↑20.8%, p=0.87
Effectiveness of REGEN-COV combination monoclonal antibody infusion to reduce risk of COVID-19 hospitalization in pregnancy: A retrospective cohort study
Details   Retrospective 764 pregnant patients with COVID-19 in the USA, 88 treated with casirivimab/imdevimab, showing no significant difference in outcomes.
Sep 9
Early Kneidinger et al., Infection, doi:10.1007/s15010-022-01914-8
severe case, ↓97.2%, p=0.45
Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study
Details   Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early casirivimab/imdevimab use.
Jul 11
Early Kadowaki et al., Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2022.07.002 Timing of REGEN-COV administration and progression to severe COVID-19
Details   Retrospective 342 patients in Japan, showing significantly greater efficacy of casirivimab/imdevimab with earlier treatment. The proportion of patients progressing to severe COVID-19 increased daily from symptom onset and increased sharpl..
Jun 4
Early Levey et al., American Journal of Obstetrics & Gynecology MFM, doi:10.1016/j.ajogmf.2022.100673
ICU, ↓30.6%, p=1.00
Outcomes of pregnant patients treated with REGEN-COV during the COVID-19 pandemic
Details   Retrospective 86 pregnant COVID-19 patients, 36 treated with casirivimab/imdevimab, showing no significant difference in COVID-19 outcomes with treatment.
May 26
Early Miyashita et al., Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2022.05.012
ventilation, ↓33.3%, p=1.00
Clinical efficacy of casirivimab-imdevimab antibody combination treatment in patients with COVID-19 Delta variant
Details   Retrospective 461 patients treated with casirivimab/imdevimab in Japan, and 461 matched controls, showing lower oxygen requirements with treatment.
May 5
Early Faraone et al., Research Square, doi:10.21203/rs.3.rs-1170976/v1 (Preprint)
death, ↓92.2%, p=0.03
REGEN-COV antibody cocktail (casirivimab/imdevimab) for the treatment of inpatients with early hospital-acquired COVID-19: a single center experience
Details   Retrospective 34 patients with hospital-acquired COVID-19, showing lower mortality and oxygen requirements with early casirivimab/imdevimab treatment.
Mar 31
Early Wilden et al., Journal of the National Comprehensive Cancer Network, doi:10.6004/jnccn.2021.7309
hosp., ↓82.0%, p=0.004
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.
Feb 28
Early Wei et al., medRxiv, doi:10.1101/2022.02.28.22270796 (Preprint)
death/hosp., ↓61.0%, p<0.0001
Real-world Effectiveness of Casirivimab and Imdevimab in Patients With COVID-19 in the Ambulatory Setting: An Analysis of Two Large US National Claims Databases
Details   Retrospective 4,396 casirivimab/imdevimab patients in the USA, showing lower combined mortality/hospitalization (CDM database) and lower hospitalization (PMTX+ database) with treatment.
Feb 16
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.
Feb 3
Early Osugi et al., Cureus, doi:10.7759/cureus.21882
hosp., ↓24.0%, p=0.65
Clinical Prognosis of Patients With Mild COVID-19 Treated With Casirivimab/Imdevimab in Japan
Details   Retrospective 104 outpatients in Japan, 30 treated with casirivimab/imdevimab, showing no significant difference in hospitalization.
Jan 31
Early Shopen et al., medRxiv, doi:10.1101/2022.01.29.22270090 (Preprint)
severe case, ↑45.6%, p=0.26
Doubtful Clinical Benefit of Casirivimab-Imdevimab Treatment for Disease Severity Outcome of High-Risk Patients with SARS-CoV-2 Delta Variant Infection
Details   Retrospective 359 COVID+ patients in Israel, 116 treated with casirivimab/imdevimab, showing no significant difference with treatment in multivariable analysis.
Jan 24
Animal Tatham et al., bioRxiv, doi:10.1101/2022.01.23.477397 (Preprint)
animal study
Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV 2 Omicron variant (B.1.1.529) in K18-hACE2 mice
Details   K18-hACE2 mouse study showing that casirivimab/imdevimab was not effective for omicron at doses 2x higher than those effective for previous variants.
Jan 14
Early O'Brien et al., JAMA, doi:10.1001/jama.2021.24939768
hosp., ↓85.5%, p=0.25
Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial
Details   RCT 204 asymptomatic COVID+ patients, 100 treated with subcutaneous casirivimab/imdevimab, showing lower development of symptoms, lower hospitalization, and faster viral clearance with treatment. Study conducted prior to widespread circul..
Dec 21
2021
Early Suzuki et al., medRxiv, doi:10.1101/2021.12.19.21268078 (Preprint)
death, ↑200.0%, p=1.00
Real-world clinical outcomes of treatment with casirivimab-imdevimab among patients with mild-to-moderate coronavirus disease 2019 during the Delta variant pandemic
Details   Retrospective 949 patients in Japan, 314 treated with casirivimab/imdevimab showing significantly lower risk of deterioration with treatment.
Dec 20
2021
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.
Dec 19
2021
Early Komagamine et al., Journal of General and Family Medicine, doi:10.1002/jgf2.516
ventilation, ↓77.3%, p=0.51
The effect of casirivimab with imdevimab on disease progression in nonsevere COVID‐19 patients in a single hospital in Japan
Details   Combined retrospective/prospective study in Japan with 53 casirivimab/imdevimab patients and 75 control patients, showing significantly lower progression with treatment.
Dec 17
2021
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..
Dec 15
2021
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.
Dec 1
2021
Late McCreary et al., medRxiv, doi:10.1101/2021.11.30.21266756 (Preprint)
death, ↓93.0%, p=0.009
Association of subcutaneous or intravenous route of administration of casirivimab and imdevimab monoclonal antibodies with clinical outcomes in COVID-19
Details   Prospective study comparing subcutaneous and intravenous casirivimab/imdevimab, and comparing to a PSM matched control set, showing significantly lower mortality and hospitalization with treatment. Controls were matched with EUA-eligible ..
Nov 16
2021
PrEPPEP Isa et al., medRxiv, doi:10.1101/2021.11.10.21265889 (Preprint)
symp. case, ↓92.6%, p=0.002
Repeat Subcutaneous Administration of REGEN-COV® in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19
Details   RCT 969 patients, 729 treated with monthly subcutaneous casirivimab/imdevimab, showing significantly lower risk of COVID-19 with treatment. There were no grade 3 injection site reactions or hypersensitivity reactions. Slightly more TEAEs ..
Nov 8
2021
Late Somersan-Karakaya et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiac320 (date from earlier preprint)
death, ↓35.9%, p=0.02
Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
Details   RCT 1,336 hospitalized patients with symptom onset <=10 days on low-flow or no supplemental oxygen, showing lower mortality with treatment. Cohorts 2&3 were paused mid-trial due to increased deaths in the treatment arm and these results w..
Nov 8
2021
PrEPPEP Regeneron Press Release (News)
hosp., ↓92.3%, p=0.03
New phase 3 analyses show that a single dose of REGEN-COV® (casirivimab and imdevimab) provides long-term protection against COVID-19
Details   Long-term results for PEP RCT NCT04452318, with 841 baseline seronegative casirivimab/imdevimab patients and 842 placebo patients, showing significantly lower cases with treatment.
Nov 4
2021
Early Kakinoki et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.01.067 (date from earlier preprint)
progression, ↓57.6%, p=0.049
Impact of Antibody Cocktail Therapy Combined with Casirivimab and Imdevimab on Clinical Outcome for Covid-19 patients in A Real-Life Setting: A Single Institute Analysis
Details   Retrospective 55 patients in Japan treated a median of 3 days from symptom onset with casirivimab/imdevimab, and 53 control patients, showing lower risk of further treatment including oxygen or antivirals.
Nov 2
2021
In Vitro Kaleta et al., Research Square, doi:10.21203/rs.3.rs-995033/v1 (Preprint) (In Vitro)
In Vitro
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..
Oct 20
2021
Early Bierle et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab570 (date from earlier preprint)
ICU, ↓88.9%, p=0.16
Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities
Details   Retrospective 1,395 vaccinated COVID-19 cases, showing significantly lower hospitalization and oxygen supplementation with monoclonal antibody treatment, primarily casirivimab-imdevimab. Hospitalization was significantly associated with..
Oct 8
2021
Early Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512
death, ↓77.5%, p=0.18
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..
Jun 23
2021
Early Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331
death, ↓98.3%, p=0.63
Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19
Details   Retrospective 115 patients treated with casirivimab/imdevimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors falsely state that "no other COVID-19 therapies for ambulatory patient..
Jun 16
2021
Late Horby et al., The Lancet, doi:10.1016/S0140-6736(22)00163-5 (date from earlier preprint)
death, ↓6.0%, p=0.16
Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Details   RCT 9,785 hospitalized patients in the UK showing lower mortality with casirivimab/imdevimab, with statistical significance reached for baseline seronegative patients.
May 21
2021
Early Weinreich et al., NEJM, doi:10.1056/NEJMoa2108163 (date from earlier preprint)
death, ↓50.0%, p=0.45
REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19
Details   RCT 4,057 outpatients with >=1 risk factor for severe disease, showing significantly lower combined hospitalization/death, and significantly faster recovery with treatment. Median time from onset of symptoms 3 days. NCT04425629.
Apr 12
2021
PrEPPEP O'Brien et al., NEJM, doi:10.1056/NEJMoa2109682 (press release 4/12/21)
hosp./ER, ↓88.9%, p=0.06
Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19
Details   Prophylaxis trial reporting lower hospitalization/ER and symptomatic cases, and faster recovery with 1,200mg subcutaneous casirivimab with imdevimab. The same trial has updated results available in . NCT04452318.
Mar 23
2021
Early Regeneron Press Release (Preprint)
death/hosp., ↓71.3%, p<0.0001
New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19
Details   Press release for new phase III data showing lower hospitalization/mortality, and faster symptom resolution among the subset of patients with at least one risk factor. Some variants may escape antibodies .
Jan 26
2021
PrEPPEP Regeneron Press Release (Preprint)
symp. case, ↓93.6%, p=0.009
Regeneron Reports Positive Interim Data with REGEN-COV™ Antibody Cocktail used as Passive Vaccine to Prevent COVID-19
Details   Interim results of REGEN-COV prophylaxis showing 100% prevention of symptomatic infection (8/223 placebo vs. 0/186 REGEN-COV), and approximately 50% lower overall rates of infection (symptomatic and asymptomatic) (23/223 placebo vs. 10/18..
Sep 29
2020
Early Regeneron Press Release (Preprint)
recov. time, ↓38.0%, p=0.22
Regeneron's REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients
Details   Analysis of the first 275 patients in a trial of the REGN-COV2 antibody cocktail showing reductions in viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. Greatest improvements were seen with patients..
Aug 21
2020
In Vitro Baum et al., Science, 21 Aug 2020, 369:6506, 1014-1018, doi:10.1126/science.abd0831 (In Vitro)
In Vitro
Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies
Details   In Vitro study showing that, under pressure from individual antibodies, mutant viruses were rapidly selected that evaded the blocking function of all individual antibodies tested, including antibodies that potently bind to highly-conserve..
Aug 21
2020
Animal Hansen et al., Science, 21 Aug 2020, 369:6506, 1010-1014, doi:10.1126/science.abd0827
animal study
Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail
Details   Study using humanized mice and blood samples from recovered COVID-19 patients to generate antibodies targeting multiple different regions of the critical receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. The spike protein on ..
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