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Regdanvimab for COVID-19
12 studies with >7,000 patients
Serious outcome risk
Regdanvimab
Control
Significantly lower risk for mortality, hospitalization, progression, and recovery.
10 studies from 7 independent teams (all from the same country) show significant benefit.
COVID-19 Regdanvimab studies · October 2026
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2, BA.4, BA.51, XBB.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.1.12. mAb use may create new variants that spread globally3-5, and may be associated with increased risk of autoimmune disease6, prolonged viral loads, clinical deterioration, and immune escape4,7-11. Regdanvimab was adopted in 27 countries. Recent:
Luxi
Ashoor.
Covid Analysis Regdanvimab reduced COVID-19 risk: real-time meta-analysis of 12 studies (Version 11)
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..
Jul 22
 Luxi et al., Drug Safety, doi:10.1007/s40264-026-01705-2 Challenges and Opportunities for Signal Detection During Public Health Emergencies: An Historical Re-evaluation of the Disproportionality Analysis of the ADR Reporting of Anti-COVID-19 Monoclonal Antibodies in Vigibase
Disproportionality analysis of 15,250 de-duplicated individual case safety reports from VigiBase (February 2020-December 2023) identifying potential cardiovascular and neurological safety signals for monoclonal antibodies (mAbs) used in e..
Mar 13
2025
 Vukovikj et al., Eurosurveillance, doi:10.2807/1560-7917.ES.2025.30.10.2400252 Impact of SARS-CoV-2 variant mutations on susceptibility to monoclonal antibodies and antiviral drugs: a non-systematic review, April 2022 to October 2024
Review of SARS-CoV-2 variant mutations and their impact on susceptibility to monoclonal antibodies and antivirals. Mutations in the ORF1ab region led to decreased susceptibility to paxlovid, while nsp12 mutations reduced efficacy for remd..
Aug 19
2024
 Ashoor, D., MDPI AG, doi:10.20944/preprints202408.1340.v1 In Silico Evaluation of Ten Monoclonal Antibodies Neutralization Power of SARS-CoV-2 Variants EG.5, BA.2.86 and JN.1
In silico study evaluating the neutralization power of 10 monoclonal antibodies (9 previously EUA-granted, 1 under clinical investigation) against SARS-CoV-2 variants EG.5, BA.2.86, and JN.1. Most available neutralizing antibodies have si..
Aug 11
2024
 Focosi, 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
2024
 Casadevall 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
2024
 Lee 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
2024
 Hwang 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
2024
 Kee 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
 Noh 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. ..
Oct 20
2023
 Fomina et al., Frontiers in Immunology, doi:10.3389/fimmu.2023.1259725 Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period
415% worse viral clearance (p=0.008). Prospective study of 77 COVID-19 outpatients showing improved efficacy with tixagevimab/cilgavimab compared to regdanvimab during Omicron variant dominance.
Sep 28
2023
 Pochtovyi 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
 Haars 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
 Kim 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
 Jang 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
 Moench et al., eBioMedicine, doi:10.1016/j.ebiom.2025.105582 (date from preprint) A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in healthy volunteers
Phase 1 RCT of 23 healthy adults, showing nebulized IN-006, a reformulation of regdanvimab, was well-tolerated, with transient mild adverse events, and achieved high nasal fluid concentrations that were orders of magnitude above typical a..
Aug 8
2022
 Kim 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
 Jang 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
 Park 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
 Chae 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
 Choi 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
 Streinu-Cercel 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
 Lee 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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