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Effectiveness and Safety of Regdanvimab in Patients With Mild-To-Moderate COVID-19: A Retrospective Cohort Study

Park et al., Journal of Korean Medical Science, doi:10.3346/jkms.2022.37.e102

Mar 2022

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Regdanvimab

34th treatment shown to reduce risk in March 2022

^*, now known with p = 0.0000000045 from 10 studies, recognized in 27 countries. Efficacy is variant dependent.

Lower risk for mortality, hospitalization, progression, and recovery.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19early.org

Retrospective propensity score matched analysis of 970 high-risk mild-moderate COVID-19 patients in South Korea, showing regdanvimab significantly reduced risk of disease progression or death by 77% compared to standard care alone. No deaths occurred in either group. Regdanvimab also significantly shortened hospital stay and reduced hematological adverse events.

Confounding by treatment propensity. This study analyzes a population where only a fraction of eligible patients received the treatment. Patients receiving treatment may be more likely to follow other recommendations, more likely to receive additional care, and more likely to use additional treatments that are not tracked in the data (e.g., nasal/oral hygiene c19early.org, c19early.org (B), vitamin D c19early.org (C), etc.) — either because the physician recommending regdanvimab also recommended them, or because the patient seeking out regdanvimab is more likely to be familiar with the efficacy of additional treatments and more likely to take the time to use them. Therefore, these kind of studies may overestimate the efficacy of treatments.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2, BA.4, BA.5 Haars, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.1 Pochtovyi.

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risk of progression, 79.4% lower, RR 0.21, p < 0.001, treatment 19 of 377 (5.0%), control 81 of 377 (21.5%), NNT 6.1, adjusted per study, odds ratio converted to relative risk, disease aggravation or death, propensity score matching, multivariable.

hospitalization time, 13.1% lower, relative time 0.87, p < 0.001, treatment mean 11.9 (±3.3) n=377, control mean 13.7 (±5.4) n=377, propensity score matching.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Park et al., 29 Mar 2022, retrospective, South Korea, peer-reviewed, 5 authors, study period 1 December, 2020 - 16 April, 2021. Contact: mdhuh@hanmail.net.

This Paper Regdanvimab All

Effectiveness and Safety of Regdanvimab in Patients With Mild-To-Moderate COVID-19: A Retrospective Cohort Study

Susin Park, Nam Kyung Je, Dong Wan Kim, Miran Park, MD Jeonghun Heo

Journal of Korean Medical Science, doi:10.3346/jkms.2022.37.e102

Background: Regdanvimab has decreased the time to clinical recovery from coronavirus disease 2019 (COVID-19) and lowered the rate of oxygen therapy according to the results from phase 2/3 randomized controlled trial. More information is needed about the effects and safety of regdanvimab. Methods: We analyzed data for patients with high-risk mild or moderate COVID-19 being admitted to Busan Medical Center between December 1, 2020 and April 16, 2021. A propensity score (PS) matched analysis was conducted to compare patients treated with and without regdanvimab. The primary outcome was in-hospital death or disease aggravation which means the need for oxygen therapy (low-or high-flow oxygen therapy and mechanical ventilation) and secondary outcomes comprised the length of hospital stay and adverse reactions. Results: Among 1,617 selected patients, 970 (60.0%) were indicated for regdanvimab. Of these, 377 (38.9%) were administered with regdanvimab. Among a 1:1 PS-matched cohort of 377 patients each treated with and without regdanvimab, 19 (5%) and 81 (21.5%) reached the composite outcome of death, or disease aggravation, respectively (absolute risk difference, -16.4%; 95% confidence interval [CI], -21.1, -11.7; relative risk difference, 76.5%; P < 0.001). Regdanvimab significantly reduced the composite outcome of death, or disease aggravation in univariate (odds ratio [OR], 0.194; 95% CI, 0.112-0.320; P < 0.001) and multivariableadjusted analyses (OR, 0.169; 95% CI, 0.095-0.289; P < 0.001). The hospital stay was shorter for the group with than without regdanvimab. Some hematological adverse reactions were more frequent in the group without regdanvimab, but other adverse reactions did not significantly differ between the groups. Conclusion: Regdanvimab was associated with a significantly lower risk of disease aggravation without increasing adverse reactions.

SUPPLEMENTARY MATERIALS Supplementary Table 1 Missing baseline laboratory data in propensity score-matched cohort Click here to view Supplementary Table 2 Associations between regdanvimab and primary endpoint in PS-matched and overall cohorts Click here to view Supplementary Table 3 Clinical outcomes in overall cohort Click here to view Supplementary Fig. 1 Distribution of covariates before and after propensity matching study patients who were and were not treated with regdanvimab. Click here to view Supplementary Fig. 2 Standardized mean differences in unadjusted and adjusted cohorts. Click here to view

References

Baum, Fulton, Wloga, Copin, Pascal et al., Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies, Science, doi:10.1126/science.abd0831

Chow, Khanna, Kethireddy, Yamane, Levine et al., Aspirin use is associated with decreased mechanical ventilation, intensive care unit admission, and in-hospital mortality in hospitalized patients with coronavirus disease 2019, Anesth Analg, doi:10.1213/ANE.0000000000005292

Daniels, Sitapati, Zhang, Zou, Bui et al., Relation of statin use prior to admission to severity and recovery among COVID-19 inpatients, Am J Cardiol, doi:10.1016/j.amjcard.2020.09.012

Eom, Ison, Streinu-Cercel, Săndulescu, Preotescu et al., Efficacy and safety of CT-P59 plus standard of care: a phase 2/3 randomized, double-blind, placebo-controlled trial in outpatients with mild-to-moderate SARS-CoV-2 infection, Res Sq, doi:10.21203/rs.3.rs-296518/v1

Fosbøl, Butt, Østergaard, Andersson, Selmer et al., Association of angiotensinconverting enzyme inhibitor or angiotensin receptor blocker use with COVID-19 diagnosis and mortality, JAMA, doi:10.1001/jama.2020.11301

Gebhard, Regitz-Zagrosek, Neuhauser, Morgan, Klein, Impact of sex and gender on COVID-19 outcomes in Europe, Biol Sex Differ, doi:10.1186/s13293-020-00304-9

Gupta, Madhavan, Poterucha, Defilippis, Hennessey et al., Association between antecedent statin use and decreased mortality in hospitalized patients with COVID-19, Nat Commun, doi:10.1038/s41467-021-21553-1

Hj, Kim, Kang, Yang, Lee, Prediction of COVID-19-related mortality and 30-day and 60day survival probabilities using a nomogram, J Korean Med Sci, doi:10.3346/jkms.2021.36.e248

Hurt, Wheatley, Neutralizing antibody therapeutics for COVID-19, Viruses, doi:10.3390/v13040628

Jahanshahlu, Rezaei, Monoclonal antibody as a potential anti-COVID-19, Biomed Pharmacother, doi:10.1016/j.biopha.2020.110337

Jia, Gong, Will mutations in the spike protein of SARS-CoV-2 lead to the failure of COVID-19 vaccines?, J Korean Med Sci, doi:10.3346/jkms.2021.36.e124

Kim, Ryoo, Huh, Joo, Kim et al., Revised Korean Society of Infectious Diseases/ National Evidence-based Healthcarea collaborating agency guidelines on the treatment of patients with COVID-19, Infect Chemother, doi:10.3947/ic.2021.0303

Kim, Ryu, Lee, Kim, Seo et al., A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein, Nat Commun, doi:10.1038/s41467-020-20602-5

Lam, Chow, Vo, Hou, Li et al., Continued in-hospital angiotensin-converting enzyme inhibitor and angiotensin ii receptor blocker use in hypertensive COVID-19 patients is associated with positive clinical outcome, J Infect Dis, doi:10.1093/infdis/jiaa447

Lee, Choe, Jeong, Kim, Kim et al., Importation and transmission of SARS-CoV-2 B.1.1.529 (Omicron) variant of concern in Korea, November 2021, J Korean Med Sci, doi:10.3346/jkms.2021.36.e346

Li, Xu, Yu, Wang, Tao et al., Risk factors for severity and mortality in adult COVID-19 inpatients in Wuhan, J Allergy Clin Immunol, doi:10.1016/j.jaci.2020.04.006

Orders, An EUA for sotrovimab for treatment of COVID-19, Med Lett Drugs Ther

Osborne, Veigulis, Arreola, Mahajan, Röösli et al., Association of mortality and aspirin prescription for COVID-19 patients at the Veterans Health Administration, PLoS One, doi:10.1371/journal.pone.0246825

Pastor-Nieto, Checa-Díaz, González-Muñoz, Martín-Fuentes, Vergara-Sánchez et al., Prior treatment with immunosuppressants among COVID-19 inpatients at one hospital in Spain, J Eur Acad Dermatol Venereol, doi:10.1111/jdv.16798

Prabakaran, Zhu, Xiao, Biragyn, Dimitrov et al., Potent human monoclonal antibodies against SARS CoV, Nipah and Hendra viruses, Expert Opin Biol Ther, doi:10.1517/14712590902763755

Ryu, Hong, Lim, Cho, Hwang et al., Clinical features of adult COVID-19 patients without risk factors before and after the nationwide SARS-CoV-2 B.1.617.2 (Delta)-variant outbreak in Korea: experience from Gyeongsangnam-do, J Korean Med Sci, doi:10.3346/jkms.2021.36.e341

Ryu, Song, Kim, Kim, Kim et al., Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant, doi:10.1016/j.bbrc.2021.06.016

Saphire, Schendel, Gunn, Milligan, Alter, Antibody-mediated protection against Ebola virus, Nat Immunol, doi:10.1038/s41590-018-0233-9

Scully, Haverfield, Ursin, Tannenbaum, Klein, Considering how biological sex impacts immune responses and COVID-19 outcomes, Nat Rev Immunol, doi:10.1038/s41577-020-0348-8

Wang, Li, Drabek, Okba, Van Haperen et al., A human monoclonal antibody blocking SARS-CoV-2 infection, Nat Commun, doi:10.1038/s41467-020-16256-y

Weinreich, Sivapalasingam, Norton, Ali, Gao et al., REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19, N Engl J Med, doi:10.1056/NEJMoa2035002

Yi, Kim, Choe, Hong, Choi et al., SARS-CoV-2 delta variant breakthrough infection and onward secondary transmission in household, J Korean Med Sci, doi:10.3346/jkms.2022.37.e12

Zhou, Yang, Wang, Hu, Zhang et al., A pneumonia outbreak associated with a new coronavirus of probable bat origin, Nature, doi:10.1038/s41586-020-2012-7

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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment 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.

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