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Meta AnalysisMeta
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. mAb use may create new variants that spread globally Focosi, Leducq, and may be associated with prolonged viral loads, clinical deterioration, and immune escape Casadevall, Choudhary, Günther, Leducq.
Regdanvimab was adopted
in 27 countries.
Submit updates/corrections .
Summary.
Dec 23 |
Regdanvimab reduced COVID-19 risk: real-time meta analysis of 11 studies | |
| Significantly lower risk is seen for mortality, hospitalization, progression, and recovery. 10 studies from 7 independent teams (all from the same country) show significant benefit. Meta analysis using the most serious outcome reported sh.. | ||
Aug 11 |
, D., Current Topics in Microbiology and Immunology, doi:10.1007/82_2024_268 | Monoclonal Antibody Therapies Against SARS-CoV-2: Promises and Realities |
| Review of monoclonal antibodies for SARS-CoV-2. Author notes that the omicron variant has reset achievements to date. | ||
Aug 8 |
et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae408 | Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship |
| Review arguing against use of single monoclonal antibodies for COVID-19 treatment, particularly in immunosuppressed patients, due to the risk of rapidly selecting for resistant viral variants. Authors suggest that while monoclonal antibod.. | ||
May 23 |
et al., Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfae069.1573 | Effectiveness of regdanvimab on clinical outcomes in COVID-19 infected patients on hemodialysis |
| 59% lower mortality (p=0.002). Retrospective 230 hemodialysis patients with COVID-19, showing lower mortality with regdanvimab. Details of the adjusted results are not provided. | ||
Apr 12 |
et al., Infectious Diseases and Therapy, doi:10.1007/s40121-024-00971-w | Effect of Regdanvimab on Mortality in Patients Infected with SARS-CoV-2 Delta Variants: A Propensity Score-Matched Cohort Study |
| 83% lower mortality (p=0.12), 33% lower ICU admission (p=0.49), and 55% lower need for oxygen therapy (p=0.01). PSM retrospective 378 hospitalized COVID-19 patients in Korea showing lower progression with regdanvimab treatment. | ||
Jan 23 |
et al., Kidney Research and Clinical Practice, doi:10.23876/j.krcp.23.137 | Effectiveness of regdanvimab on mortality in COVID-19 infected patients on hemodialysis |
| Retrospective 230 hospitalized COVID-19 patients on hemodialysis, reporting lower mortality with regdanvimab treatment. The results are conflicting, with for example the text reporting HR 0.28 for regdanvimab in multivariable analysis, ho.. | ||
Nov 10 2023 |
et al., Medicine, doi:10.1097/MD.0000000000035987 | Clinical outcomes of mild to moderate coronavirus disease 2019 patients treated with Regdanvimab in delta-variant outbreak: Retrospective cohort study |
| Retrospective 101 hospitalized COVID-19 patients in South Korea examining outcomes with the monoclonal antibody treatment regdanvimab, comparing 31 patients during the delta variant outbreak period to 49 patients with pre-delta variants. .. | ||
Sep 28 2023 |
et al., Vaccines, doi:10.3390/vaccines11101533 | In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1 |
| In Vitro study showing sharply reduced neutralization of SARS-CoV-2 variants XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1 with monoclonal antibodies cilgavimab, tixagevimab, imdevimab, etsevimab, casirivim.. | ||
Sep 27 2023 |
et al., Microorganisms, doi:10.3390/microorganisms11102417 | Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023 |
| Analysis of 7,950 SARS-CoV-2 samples from central Sweden collected between March 2022 and May 2023 tracking the prevalence of omicron sublineages and mutations in the spike protein conferring resistance to monoclonal antibodies over time... | ||
May 15 2023 |
et al., Frontiers in Cellular and Infection Microbiology, doi:10.3389/fcimb.2023.1192512 | Effectiveness of regdanvimab treatment for SARS-CoV-2 delta variant, which exhibited decreased in vitro activity: a nationwide real-world multicenter cohort study |
| 51% lower progression (p=0.0002) and 32% lower need for oxygen therapy (p<0.0001). Retrospective 2,214 mild/moderate COVID-19 patients in South Korea, 1,095 treated with regdanivimab, showing lower oxygen requirements and lower progression to severe disease with treatment in the overall cohort, but not within the delta .. | ||
Jan 6 2023 |
et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.12.035 | Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant |
| 12% shorter hospitalization (p<0.0001), 49% lower need for oxygen therapy (p<0.0001), and 68% higher hospital discharge (p<0.0001). Retrospective 722 hospitalized mild-to-moderate COVID-19 patients in Korea showing lower risk of disease progression with regdanvimab treatment. | ||
Aug 21 2022 |
et al., medRxiv, doi:10.1101/2022.08.17.22278748 | A randomized, double-blind, Phase 1 study of IN-006, an inhaled antibody treatment for COVID-19 |
| Phase 1 study of 23 healthy adults showing inhaled regdanvimab (IN-006) was well tolerated after single doses of 30mg and 90mg and 7 daily 90mg doses. High concentrations were achieved in nasal fluids and serum, over 1000 times the inhibi.. | ||
Aug 8 2022 |
et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac406 | A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019 |
| 86% lower ventilation (p=0.25), 91% lower ICU admission (p=0.06), 69% lower need for oxygen therapy (p<0.0001), and 69% lower hospitalization (p<0.0001). RCT 1,315 outpatients in South Korea, showing lower progression and improved recovery with regdanvimab. | ||
May 16 2022 |
et al., Current Therapeutic Research, doi:10.1016/j.curtheres.2022.100675 | Clinical Effectiveness of Regdanvimab Treatment for Mild-to-Moderate COVID-19: A Retrospective Cohort Study |
| 60% lower need for oxygen therapy (p<0.0001), 44% higher hospital discharge (p=0.03), and 13% shorter hospitalization (p=0.003). Retrospective 317 hospitalized mild-moderate COVID-19 patients in South Korea showing significantly lower rates of oxygen desaturation (SpO2 <94%) at 28 days (primary outcome) with regdanvimab monoclonal antibody treatment (13%) compared .. | ||
Mar 29 2022 |
et al., Journal of Korean Medical Science, doi:10.3346/jkms.2022.37.e102 | Effectiveness and Safety of Regdanvimab in Patients With Mild-To-Moderate COVID-19: A Retrospective Cohort Study |
| 79% lower progression (p<0.0001) and 13% shorter hospitalization (p<0.0001). 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 dea.. | ||
Mar 18 2022 |
et al., Tropical Medicine and Infectious Disease, doi:10.3390/tropicalmed7030051 | The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study |
| 71% lower mortality (p=1), 64% lower ventilation (p=0.46), and 9% shorter hospitalization (p=0.56). Retrospective 124 hospitalized severe COVID-19 patients receiving oxygen and remdesivir treatment in South Korea. A subgroup of 25 patients also received the monoclonal antibody regdanvimab prior to remdesivir. The regdanvimab subgroup ha.. | ||
Mar 8 2022 |
et al., Infection & Chemotherapy, doi:10.3947/ic.2021.0140 | Effectiveness of Regdanvimab at Preventing the Need for Oxygen Therapy in Patients with Mild-to-Moderate COVID-19: A Retrospective Cohort Study |
| 76% lower need for oxygen therapy (p=0.004). Retrospective 398 hospitalized mild-to-moderate COVID-19 patients in South Korea eligible for regdanvimab treatment. 65 patients received regdanvimab, with significantly lower supplemental oxygen requirements (6.2% vs 20.1% in controls). .. | ||
Feb 2 2022 |
et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac053 | 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 |
| 54% lower need for oxygen therapy (p=0.11), 49% lower hospitalization (p=0.2), 49% lower progression (p=0.2), and 35% faster recovery (p=0.003). 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 signific.. | ||
Nov 23 2021 |
et al., Frontiers in Immunology, doi:10.3389/fimmu.2021.772320 | Effectiveness of Regdanvimab Treatment in High-Risk COVID-19 Patients to Prevent Progression to Severe Disease |
| 82% lower severe cases (p=0.002), 45% lower need for oxygen therapy (p=0.05), and 8% higher hospital discharge (p=0.001). Retrospective 778 mild COVID-19 patients showing significantly lower progression to severe disease with regdanvimab treatment. | ||
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