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All Studies   Meta Analysis    Recent:   

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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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) c19early.org Kim et al., Open Forum Infectious Dise.., Aug 2022 Favorsregdanvimab Favorscontrol 0 0.5 1 1.5 2+
35th treatment shown to reduce risk in March 2022
 
*, now with p < 0.00000000001 from 11 studies, recognized in 27 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,500+ studies for 81 treatments. c19early.org
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.51, 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.1.12.
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: helppl@gilhospital.com.
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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Treatment-emergent serious adverse events were reported in 5 of (4/652 ' '[0.6%] regdanvimab and 1/650 [0.2%] placebo).</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>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.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Clinical Trials Registration</jats:title>\n' ' <jats:p>NCT04602000; 2020-003369-20 (EudraCT).</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/ofid/ofac406', 'type': 'journal-article', 'created': {'date-parts': [[2022, 8, 8]], 'date-time': '2022-08-08T01:17:55Z', 'timestamp': 1659921475000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate ' 'Coronavirus Disease 2019', 'prefix': '10.1093', 'volume': '9', 'author': [ { 'given': 'Jin Yong', 'family': 'Kim', 'sequence': 'first', 'affiliation': [ { 'name': 'Department of Internal Medicine, Division of Infectious ' 'Diseases, Incheon Medical Center , Incheon , Republic of ' 'Korea'}]}, { 'given': 'Oana', 'family': 'Săndulescu', 'sequence': 'additional', 'affiliation': [ { 'name': 'National Institute for Infectious Diseases “Prof Dr Matei Balş,” ' 'Carol Davila University of Medicine and Pharmacy , Bucharest , ' 'Romania'}]}, { 'given': 'Liliana-Lucia', 'family': 'Preotescu', 'sequence': 'additional', 'affiliation': [ { 'name': 'National Institute for Infectious Diseases “Prof Dr Matei Balş,” ' 'Carol Davila University of Medicine and Pharmacy , Bucharest , ' 'Romania'}]}, { 'given': 'Norma E', 'family': 'Rivera-Martínez', 'sequence': 'additional', 'affiliation': [{'name': 'Oaxaca Site Management Organization , Oaxaca , Mexico'}]}, { 'given': 'Marta', 'family': 'Dobryanska', 'sequence': 'additional', 'affiliation': [ {'name': 'City Clinical Hospital 12 , Kyiv , Ukraine'}, {'name': 'ARENSIA Exploratory Medicine , Kyiv , Ukraine'}]}, { 'given': 'Victoria', 'family': 'Birlutiu', 'sequence': 'additional', 'affiliation': [ { 'name': 'Faculty of Medicine, Lucian Blaga University of Sibiu, Emergency ' 'Clinical County Hospital , Sibiu , Romania'}]}, { 'given': 'Egidia G', 'family': 'Miftode', 'sequence': 'additional', 'affiliation': [ { 'name': 'Clinical Hospital of Infectious Diseases “Sfanta Parascheva,” ' 'University of Medicine and Pharmacy “Gr. 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(regdanvimab)', 'author': 'European Medicines Agency'}, { 'key': '2022082916501028800_ofac406-B18', 'doi-asserted-by': 'crossref', 'first-page': '1706', 'DOI': '10.1016/j.clinthera.2021.08.009', 'article-title': 'Safety, virologic efficacy, and pharmacokinetics of CT-P59, a ' 'neutralizing monoclonal antibody against SARS-CoV-2 spike ' 'receptor-binding protein: two randomized, placebo-controlled, phase I ' 'studies in healthy individuals and patients with mild SARS-CoV-2 ' 'infection', 'volume': '43', 'author': 'Kim', 'year': '2021', 'journal-title': 'Clin Ther'}, { 'key': '2022082916501028800_ofac406-B19', 'doi-asserted-by': 'crossref', 'first-page': 'ofac053', 'DOI': '10.1093/ofid/ofac053', 'article-title': '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', 'volume': '9', 'author': 'Streinu-Cercel', 'year': '2022', 'journal-title': 'Open Forum Infect Dis'}, { 'key': '2022082916501028800_ofac406-B20', 'doi-asserted-by': 'publisher', 'article-title': 'Neutralization sensitivity of Omicron BA.2.75 to therapeutic monoclonal ' 'antibodies', 'volume-title': 'bioRxiv', 'author': 'Yamasoba', 'DOI': '10.1101/2022.07.14.500041'}, { 'key': '2022082916501028800_ofac406-B21', 'doi-asserted-by': 'crossref', 'first-page': '4048', 'DOI': '10.1038/s41467-021-24339-7', 'article-title': 'CVnCov and CV2CoV protect human ACE2 transgenic mice from ancestral B ' 'BavPat1 and emerging B.1.351 SARS-CoV-2', 'volume': '12', 'author': 'Hoffmann', 'year': '2021', 'journal-title': 'Nat Commun'}, { 'key': '2022082916501028800_ofac406-B22', 'doi-asserted-by': 'crossref', 'first-page': '1', 'DOI': '10.1186/s12979-020-00212-x', 'article-title': 'Obesity and COVID-19: what makes obese host so vulnerable?', 'volume': '18', 'author': 'Mohammad', 'year': '2021', 'journal-title': 'Immun Ageing'}, { 'key': '2022082916501028800_ofac406-B23', 'doi-asserted-by': 'crossref', 'first-page': 'e3377', 'DOI': '10.1002/dmrr.3377', 'article-title': 'Obesity and diabetes as high-risk factors for severe coronavirus ' 'disease 2019 (Covid-19)', 'volume': '37', 'author': 'Zhou', 'year': '2021', 'journal-title': 'Diabetes Metab Res Rev'}, { 'key': '2022082916501028800_ofac406-B24', 'doi-asserted-by': 'crossref', 'first-page': '24', 'DOI': '10.1016/j.pcd.2020.08.015', 'article-title': 'Diabetes and COVID-19: a pooled analysis related to disease severity ' 'and mortality', 'volume': '15', 'author': 'Varikasuvu', 'year': '2021', 'journal-title': 'Prim Care Diabetes'}, { 'key': '2022082916501028800_ofac406-B25', 'article-title': 'American College of Cardiology. Mitigating ASCVD risk among those ' 'previously infected with COVID-19', 'author': 'Naz'}, { 'key': '2022082916501028800_ofac406-B26', 'article-title': 'COVID-19 risk factors and risk groups', 'author': 'European Centre for Disease Prevention and Control'}, { 'key': '2022082916501028800_ofac406-B27', 'doi-asserted-by': 'crossref', 'first-page': '1382', 'DOI': '10.1056/NEJMoa2102685', 'article-title': 'Bamlanivimab plus etesevimab in mild or moderate Covid-19', 'volume': '385', 'author': 'Dougan', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2022082916501028800_ofac406-B28', 'doi-asserted-by': 'crossref', 'first-page': 'e81', 'DOI': '10.1056/NEJMoa2108163', 'article-title': 'REGEN-COV antibody combination and outcomes in outpatients with ' 'Covid-19', 'volume': '385', 'author': 'Weinreich', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2022082916501028800_ofac406-B29', 'article-title': 'Tracking of variants: VOC Delta, relative variant genome frequency per ' 'region', 'author': 'GISAID'}, { 'key': '2022082916501028800_ofac406-B30', 'doi-asserted-by': 'crossref', 'first-page': 'e040380', 'DOI': '10.1136/bmjopen-2020-040380', 'article-title': 'Temporal profile and determinants of viral shedding and of viral ' 'clearance confirmation on nasopharyngeal swabs from SARS-CoV-2-positive ' 'subjects: a population-based prospective cohort study in Reggio Emilia, ' 'Italy', 'volume': '10', 'author': 'Mancuso', 'year': '2020', 'journal-title': 'BMJ Open'}, { 'key': '2022082916501028800_ofac406-B31', 'doi-asserted-by': 'crossref', 'first-page': '772320', 'DOI': '10.3389/fimmu.2021.772320', 'article-title': 'Effectiveness of regdanvimab treatment in high-risk COVID-19 patients ' 'to prevent progression to severe disease', 'volume': '12', 'author': 'Lee', 'year': '2021', 'journal-title': 'Front Immunol'}, { 'key': '2022082916501028800_ofac406-B32', 'doi-asserted-by': 'crossref', 'first-page': '135', 'DOI': '10.1016/j.bbrc.2021.06.016', 'article-title': 'Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant', 'volume': '566', 'author': 'Ryu', 'year': '2021', 'journal-title': 'Biochem Biophys Res Commun'}, { 'key': '2022082916501028800_ofac406-B33', 'doi-asserted-by': 'crossref', 'first-page': '91', 'DOI': '10.1016/j.bbrc.2021.09.023', 'article-title': 'The in vitro and in vivo efficacy of CT-P59 against Gamma, Delta and ' 'its associated variants of SARS-CoV-2', 'volume': '578', 'author': 'Ryu', 'year': '2021', 'journal-title': 'Biochem Biophys Res Commun'}, { 'key': '2022082916501028800_ofac406-B34', 'doi-asserted-by': 'crossref', 'first-page': 'e040638', 'DOI': '10.1136/bmjopen-2020-040638', 'article-title': 'Deaths in people from Black, Asian and minority ethnic communities from ' 'both COVID-19 and non-COVID causes in the first weeks of the pandemic ' 'in London: a hospital case note review', 'volume': '10', 'author': 'Perkin', 'year': '2020', 'journal-title': 'BMJ Open'}, { 'key': '2022082916501028800_ofac406-B35', 'doi-asserted-by': 'crossref', 'first-page': '117', 'DOI': '10.1007/s40615-020-00934-0', 'article-title': 'Age, comorbid conditions, and racial disparities in COVID-19 outcomes', 'volume': '9', 'author': 'Wiley', 'year': '2022', 'journal-title': 'J Racial Ethn Health Disparities'}, { 'key': '2022082916501028800_ofac406-B36', 'doi-asserted-by': 'crossref', 'first-page': '46', 'DOI': '10.1016/j.annepidem.2020.07.007', 'article-title': 'Risk for COVID-19 infection and death among Latinos in the United ' 'States: examining heterogeneity in transmission dynamics', 'volume': '52', 'author': 'Rodriguez-Diaz', 'year': '2020', 'journal-title': 'Ann Epidemiol'}, { 'key': '2022082916501028800_ofac406-B37', 'doi-asserted-by': 'crossref', 'first-page': '382', 'DOI': '10.1038/s41577-021-00542-x', 'article-title': 'Neutralizing monoclonal antibodies for treatment of COVID-19', 'volume': '21', 'author': 'Taylor', 'year': '2021', 'journal-title': 'Nat Rev Immunol'}, { 'key': '2022082916501028800_ofac406-B38', 'doi-asserted-by': 'crossref', 'first-page': '1469', 'DOI': '10.1056/NEJMp1802256', 'article-title': 'Monoclonal antibodies for emerging infectious diseases—borrowing from ' 'history', 'volume': '378', 'author': 'Marston', 'year': '2018', 'journal-title': 'N Engl J Med'}, { 'key': '2022082916501028800_ofac406-B39', 'article-title': 'Coronavirus-19 (COVID-19): Covid-19 vaccination and domestic outbreaks ' '(2.4.) [in Korean]', 'author': 'Ministry of Health and Welfare'}], 'container-title': 'Open Forum Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofac406/45287239/ofac406.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/ofid/article-pdf/9/8/ofac406/45612082/ofac406.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/ofid/article-pdf/9/8/ofac406/45612082/ofac406.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 8, 29]], 'date-time': '2022-08-29T16:51:19Z', 'timestamp': 1661791879000}, 'score': 1, 'resource': {'primary': {'URL': 'https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofac406/6657716'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 8, 1]]}, 'references-count': 39, 'journal-issue': {'issue': '8', 'published-print': {'date-parts': [[2022, 8, 2]]}}, 'URL': 'http://dx.doi.org/10.1093/ofid/ofac406', 'relation': {}, 'ISSN': ['2328-8957'], 'subject': ['Infectious Diseases', 'Oncology'], 'published-other': {'date-parts': [[2022, 8, 1]]}, 'published': {'date-parts': [[2022, 8, 1]]}}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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