Summary of COVID-19 regdanvimab studies

1,315 patient regdanvimab early treatment RCT: 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.
Aug 2022, Open Forum Infectious Diseases, https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofac406/6657716, https://c19p.org/kim6

2. Jang et al., Clinical Effectiveness of Regdanvimab Treatment for Mild-to-Moderate COVID-19: A Retrospective Cohort Study

210 patient regdanvimab early treatment 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 to standard of care (40%). Regdanvimab also showed benefits in time to fever recovery, discharge rates, and supplemental oxygen use.
May 2022, Current Therapeutic Research, https://www.sciencedirect.com/science/article/pii/S0011393X22000145, https://c19p.org/jang3

3. Park et al., Effectiveness and Safety of Regdanvimab in Patients With Mild-To-Moderate COVID-19: A Retrospective Cohort Study

754 patient regdanvimab early treatment PSM 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 deaths occurred in either group. Regdanvimab also significantly shortened hospital stay and reduced hematological adverse events.
Mar 2022, J. Korean Medical Science, https://jkms.org/DOIx.php?id=10.3346/jkms.2022.37.e102, https://c19p.org/park5

4. Lee et al., Effectiveness of Regdanvimab Treatment in High-Risk COVID-19 Patients to Prevent Progression to Severe Disease

778 patient regdanvimab early treatment study: 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.
Nov 2021, Frontiers in Immunology, https://www.frontiersin.org/articles/10.3389/fimmu.2021.772320/full, https://c19p.org/lee12

5. Jang et al., Regdanvimab for patients with mild-to-moderate COVID-19: a retrospective cohort study and subgroup analysis of patients with the Delta variant

722 patient regdanvimab early treatment study: 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.
Jan 2023, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971222006749, https://c19p.org/jang4

6. Kim et al., Effectiveness of regdanvimab treatment for SARS-CoV-2 delta variant, which exhibited decreased in vitro activity: a nationwide real-world multicenter cohort study

2,214 patient regdanvimab early treatment 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 subset.
May 2023, Frontiers in Cellular and Infection Microbiology, https://www.frontiersin.org/articles/10.3389/fcimb.2023.1192512/full, https://c19p.org/kim12

7. Choi et al., Effectiveness of Regdanvimab at Preventing the Need for Oxygen Therapy in Patients with Mild-to-Moderate COVID-19: A Retrospective Cohort Study

398 patient regdanvimab late treatment 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). After adjusting for potential confounders, regdanvimab remained associated with lower risk of requiring supplemental oxygen (OR 0.20). There was no significant difference in mortality or hospitalization time in unadjusted results.
Mar 2022, Infection & Chemotherapy, https://icjournal.org/DOIx.php?id=10.3947/ic.2021.0140, https://c19p.org/choi4

8. Hwang et al., Effect of Regdanvimab on Mortality in Patients Infected with SARS-CoV-2 Delta Variants: A Propensity Score-Matched Cohort Study

378 patient regdanvimab early treatment 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.
Apr 2024, Infectious Diseases and Therapy, https://link.springer.com/10.1007/s40121-024-00971-w, https://c19p.org/hwang

9. Chae et al., The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study

124 patient regdanvimab early treatment 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 had significantly more oxygen-free days (primary outcome), higher oxygen saturation, less advanced respiratory support, and shorter oxygen supplementation duration compared to the remdesivir alone group.
Mar 2022, Tropical Medicine and Infectious Disease, https://www.mdpi.com/2414-6366/7/3/51, https://c19p.org/chae

10. Lee et al., Effectiveness of regdanvimab on clinical outcomes in COVID-19 infected patients on hemodialysis

230 patient regdanvimab early treatment study: 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.
May 2024, Nephrology Dialysis Transplantation, https://academic.oup.com/ndt/article/39/Supplement_1/gfae069-1573-616/7677633, https://c19p.org/lee13

11. Streinu-Cercel et al., 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

307 patient regdanvimab early treatment RCT: 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 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.
Feb 2022, Open Forum Infectious Diseases, http://dx.doi.org/10.1093/ofid/ofac053, https://c19p.org/streinucercel

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