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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Ventilation -151% Improvement Relative Risk Oxygen therapy 54% Hospitalization 49% Composite outcome 49% Recovery time 35% Time to viral- 2% Regdanvimab  Streinu-Cercel et al.  EARLY TREATMENT  DB RCT Is early treatment with regdanvimab beneficial for COVID-19? Double-blind RCT 307 patients in multiple countries Faster recovery (p<0.0001) and viral clearance (p=0.041) c19early.org Streinu-Cercel et al., Open Forum Infe.., Feb 2022 Favors regdanvimab Favors control

Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients with Mild-to-Moderate Coronavirus Disease 2019

Streinu-Cercel et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac053, NCT04602000
Feb 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. c19early.org
Phase 2 RCT with 307 outpatients with mild-moderate COVID-19, showing regdanvimab (monoclonal antibody) resulted in a minor decrease in time to negative PCR test (primary endpoint) compared to placebo, which was not statistically significant. Regdanvimab did significantly reduce time to clinical recovery by 3 days compared to placebo. A composite outcome of requiring hospitalization or oxygen therapy occurred in 4.4% of regdanvimab patients versus 8.7% placebo, with greater differences in moderate disease patients (7.2% vs 15.8% placebo). No safety issues were identified.
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 mechanical ventilation, 151.2% higher, RR 2.51, p = 1.00, treatment 1 of 203 (0.5%), control 0 of 104 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of oxygen therapy, 54.5% lower, RR 0.46, p = 0.11, treatment 8 of 203 (3.9%), control 9 of 104 (8.7%), NNT 21.
risk of hospitalization, 48.8% lower, RR 0.51, p = 0.20, treatment 9 of 203 (4.4%), control 9 of 104 (8.7%), NNT 24.
composite outcome, 48.8% lower, RR 0.51, p = 0.20, treatment 9 of 203 (4.4%), control 9 of 104 (8.7%), NNT 24.
recovery time, 35.2% lower, relative time 0.65, p < 0.001, treatment mean 5.7 (±0.408) n=203, control mean 8.8 (±1.22) n=104.
time to viral-, 1.6% lower, relative time 0.98, p = 0.04, treatment mean 12.7 (±0.969) n=203, control mean 12.9 (±0.306) n=104.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Streinu-Cercel et al., 2 Feb 2022, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 17 authors, trial NCT04602000 (history). Contact: helppl@gachon.ac.kr.
This PaperRegdanvimabAll
Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019
Anca Streinu-Cercel, Oana Săndulescu, Liliana-Lucia Preotescu, Jin Yong Kim, Yeon-Sook Kim, Shinhye Cheon, Young Rock Jang, Sang Joon Lee, Sung Hyun Kim, Ilsung Chang, Jee Hye Suh, Seul Gi Lee, Mi Rim Kim, Da Rae Chung, Han Na Kim, Adrian Streinu-Cercel, MD Joong Sik Eom
Open Forum Infectious Diseases, doi:10.1093/ofid/ofac053
Background. Regdanvimab (CT-P59) is a monoclonal antibody with neutralizing activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report on part 1 of a 2-part randomized, placebo-controlled, double-blind study for patients with mild-to-moderate coronavirus disease 2019 . Methods. Outpatients with mild-to-moderate COVID-19 received a single dose of regdanvimab 40 mg/kg (n = 100), regdanvimab 80 mg/kg (n = 103), or placebo (n = 104). The primary end points were time to negative conversion of SARS-CoV-2 from nasopharyngeal swab based on quantitative reverse transcription polymerase chain reaction (RT-qPCR) up to day 28 and time to clinical recovery up to day 14. Secondary end points included the proportion of patients requiring hospitalization, oxygen therapy, or mortality due to COVID-19. Results. Median (95% CI) time to negative conversion of RT-qPCR was 12.8 (9.0-12.9) days with regdanvimab 40 mg/kg, 11.9 (8.9-12.9) days with regdanvimab 80 mg/kg, and 12.9 (12.7-13.9) days with placebo. Median (95% CI) time to clinical recovery was 5.3 (4.0-6.8) days with regdanvimab 40 mg/kg, 6.2 (5.5-7.9) days with regdanvimab 80 mg/kg, and 8.8 (6.8-11.6) days with placebo. The proportion (95% CI) of patients requiring hospitalization or oxygen therapy was lower with regdanvimab 40 mg/kg (4.0% [1.6%-9.8%]) and regdanvimab 80 mg/kg (4.9% [2.1%-10.9%]) vs placebo (8.7% [4.6%-15.6%]). No serious treatment-emergent adverse events or deaths occurred. Conclusions. Regdanvimab showed a trend toward a minor decrease in time to negative conversion of RT-qPCR results compared with placebo and reduced the need for hospitalization and oxygen therapy in patients with mild-to-moderate COVID-19. Clinical trial registration. NCT04602000 and EudraCT 2020-003369-20.
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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