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0 0.5 1 1.5 2+ Mortality 50% Improvement Relative Risk Ventilation 86% ICU admission 91% Oxygen therapy 69% Hospitalization 69% Progression 70% Progression, high-risk 72% Viral clearance 32% Regdanvimab  Kim et al.  EARLY TREATMENT  DB RCT Is early treatment with regdanvimab beneficial for COVID-19? Double-blind RCT 1,315 patients in multiple countries (Jan - Apr 2021) Lower need for oxygen therapy (p<0.0001) and lower hospitalization (p<0.0001) Kim et al., Open Forum Infectious Dise.., Aug 2022 Favors regdanvimab Favors control

A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019

Kim et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac406, NCT04602000
Aug 2022  
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35th treatment shown to reduce risk in March 2022
*, now known with p = 0.0000009 from 7 studies, recognized in 27 countries. Efficacy is variant dependent.
Lower risk for hospitalization, progression, and recovery.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments.
RCT 1,315 outpatients in South Korea, showing lower progression and improved recovery with regdanvimab.
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.
risk of death, 49.8% lower, RR 0.50, p = 1.00, treatment 1 of 656 (0.2%), control 2 of 659 (0.3%), NNT 662.
risk of mechanical ventilation, 85.7% lower, RR 0.14, p = 0.25, treatment 0 of 656 (0.0%), control 3 of 659 (0.5%), NNT 220, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of ICU admission, 90.9% lower, RR 0.09, p = 0.06, treatment 0 of 656 (0.0%), control 5 of 659 (0.8%), NNT 132, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of oxygen therapy, 69.2% lower, RR 0.31, p < 0.001, treatment 15 of 656 (2.3%), control 49 of 659 (7.4%), NNT 19.
risk of hospitalization, 69.1% lower, RR 0.31, p < 0.001, treatment 16 of 656 (2.4%), control 52 of 659 (7.9%), NNT 18.
risk of progression, 69.7% lower, RR 0.30, p < 0.001, treatment 16 of 656 (2.4%), control 53 of 659 (8.0%), NNT 18.
risk of progression, 71.6% lower, RR 0.28, p < 0.001, treatment 14 of 446 (3.1%), control 48 of 434 (11.1%), NNT 13, high-risk patients.
risk of no viral clearance, 32.4% lower, RR 0.68, p < 0.001, treatment 612, control 618, inverted to make RR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kim et al., 8 Aug 2022, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, median age 48.0, 24 authors, study period 18 January, 2021 - 24 April, 2021, average treatment delay 4.0 days, trial NCT04602000 (history). Contact:
This PaperRegdanvimabAll
A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019
Jin Yong Kim, Oana Săndulescu, Liliana-Lucia Preotescu, Norma E Rivera-Martínez, Marta Dobryanska, Victoria Birlutiu, Egidia G Miftode, Natalia Gaibu, Olga Caliman-Sturdza, Simin-Aysel Florescu, Hye Jin Shi, Anca Streinu-Cercel, Adrian Streinu-Cercel, Sang Joon Lee, Sung Hyun Kim, Ilsung Chang, Yun Ju Bae, Jee Hye Suh, Da Rae Chung, Sun Jung Kim, Mi Rim Kim, Seul Gi Lee, Gahee Park, MD Joong Sik Eom
Open Forum Infectious Diseases, doi:10.1093/ofid/ofac406
Background. We evaluated clinical effectiveness of regdanvimab (CT-P59), a severe acute respiratory syndrome coronavirus 2 neutralizing monoclonal antibody, in reducing disease progression and clinical recovery time in patients with mild-to-moderate coronavirus disease 2019 (COVID-19), primarily Alpha variant. Methods. This was phase 3 of a phase 2/3 parallel-group, double-blind, randomized clinical trial. Outpatients with mild-tomoderate COVID-19 were randomized to single-dose regdanvimab 40 mg/kg (n = 656) or placebo (n = 659), alongside standard of care. The primary endpoint was COVID-19 disease progression up to day 28 among "high-risk" patients. Key secondary endpoints were disease progression (all randomized patients) and time to recovery (high-risk and all randomized patients). Results. Of 1315 randomized patients, 880 were high risk; the majority were infected with Alpha variant. The proportion with disease progression was lower (14/446, 3.1% [95% confidence interval {CI}, 1.9%-5.2%] vs 48/434, 11.1% [95% CI, 8.4%-14.4%]; P < .001) and time to recovery was shorter (median, 9.27 days [95% CI, 8.27-11.05 days] vs not reached [95% CI, 12.35-not calculable]; P < .001) with regdanvimab than placebo. Consistent improvements were seen in all randomized and non-high-risk patients who received regdanvimab. Viral load reductions were more rapid with regdanvimab. Infusion-related reactions occurred in 11 patients (4/652 [0.6%] regdanvimab, 7/650 [1.1%] placebo). Treatment-emergent serious adverse events were reported in 5 of (4/652 [0.6%] regdanvimab and 1/650 [0.2%] placebo). Conclusions. Regdanvimab was an effective treatment for patients with mild-to-moderate COVID-19, significantly reducing disease progression and clinical recovery time without notable safety concerns prior to the emergence of the Omicron variant. Clinical Trials Registration. NCT04602000; 2020-003369-20 (EudraCT).
Supplementary Data Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author.
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