Clinical outcomes of mild to moderate coronavirus disease 2019 patients treated with Regdanvimab in delta-variant outbreak: Retrospective cohort study

{ 'DOI': '10.1097/md.0000000000035987', 'ISSN': ['0025-7974', '1536-5964'], 'URL': 'http://dx.doi.org/10.1097/MD.0000000000035987', 'abstract': '<jats:p>Regdanvimab is a novel neutralizing antibody agent used for the treatment of ' 'coronavirus disease 2019 (COVID-19). However, the effectiveness of regdanvimab in ' 'delta-variant patients has rarely been investigated. We examined the clinical outcomes and ' 'adverse events in COVID 19 patients treated with regdanvimab in the delta-variant era. Data ' 'were collected from laboratory-confirmed COVID-19 hospitalized patients who received ' 'regdanvimab in 2021 and categorized into pre-delta and delta variant groups. The primary ' 'outcome was the need for oxygen therapy. Rescue therapy, clinical improvement, and adverse ' 'events were analyzed. Among 101 patients treated with regdanvimab, 31 (30.7%) were delta ' 'patients and 49 (48.5) were pre-delta patients. 64.4% were male, the mean age was 60.3 years, ' 'and 70 patients (69%) had at least one underlying disease. The median interval from symptom ' 'onset to injection was 4 days. Twenty-three patients (23%) needed oxygen therapy, including 9 ' '(29%) in the delta and 8 (16.3%) in the pre-delta group. (<jats:italic ' 'toggle="yes">P</jats:italic> = .176) The risk of early oxygen supplement was higher in the ' 'delta group (adjusted hazard ratio (aHR), 6.75; 95% confidence interval(CI), 1.53–29.8). The ' 'in-hospital survival rate was 100%, and no patients were admitted to the intensive care unit. ' 'Adverse events occurred in 43% of patients:13 (42%) delta patients and 23 (47%) pre-delta ' 'patients had any adverse events (<jats:italic toggle="yes">P</jats:italic> = .661). Patients ' 'treated with regdanvimab 4 days after symptom onset showed a favorable prognosis (aHR, 0.26; ' '95% CI, 0.26–0.91). We found that the high-risk mild to moderate COVID-19 patients treated ' 'with regdanvimab showed similar disease progression in delta-variant patients and pre-delta ' 'variants; however, we need to be more closely observed delta-variant patients than those in ' 'the pre-delta group despite regdanvimab treatment due to rapid disease aggravation.</jats:p>', 'author': [ { 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}], 'family': 'Noh', 'given': 'Hyeong-Jun', 'sequence': 'first'}, { 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}], 'family': 'Song', 'given': 'Jin Hwa', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Infectious Disease, Department of Internal Medicine, ' 'Veterans Health Service Medical Center, Seoul, Republic of ' 'Korea'}], 'family': 'Ham', 'given': 'Sin Young', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}], 'family': 'Park', 'given': 'Yeonkyung', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}], 'family': 'Won', 'given': 'Ha-Kyeong', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Pulmonary, Allergy and Critical Care Medicine, ' 'Department of Internal Medicine, Hallym University Kangnam ' 'Sacred Heart Hospital, Seoul, Republic of Korea'}], 'family': 'Kim', 'given': 'Soo Jung', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}], 'family': 'Chung', 'given': 'Keun Bum', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Infectious Disease, Department of Internal Medicine, ' 'Veterans Health Service Medical Center, Seoul, Republic of ' 'Korea'}], 'family': 'Kim', 'given': 'Choon Kwan', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}], 'family': 'Ahn', 'given': 'Young Mee', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}], 'family': 'Lee', 'given': 'Byoung-Jun', 'sequence': 'additional'}, { 'ORCID': 'http://orcid.org/0000-0002-8852-8736', 'affiliation': [ { 'name': 'Division of Pulmonary and Allergy Medicine, Department of ' 'Internal Medicine, Veterans Health Service Medical Center, ' 'Seoul, Republic of Korea'}, { 'name': 'Department of Internal Medicine, Graduate School of Medicine, ' 'Seoul National University, Seoul, Republic of Korea.'}], 'authenticated-orcid': False, 'family': 'Kang', 'given': 'Hye-Rin', 'sequence': 'additional'}], 'container-title': 'Medicine', 'content-domain': {'crossmark-restriction': False, 'domain': []}, 'created': { 'date-parts': [[2023, 11, 10]], 'date-time': '2023-11-10T19:00:59Z', 'timestamp': 1699642859000}, 'deposited': { 'date-parts': [[2023, 11, 13]], 'date-time': '2023-11-13T18:00:33Z', 'timestamp': 1699898433000}, 'indexed': { 'date-parts': [[2023, 11, 14]], 'date-time': '2023-11-14T00:38:48Z', 'timestamp': 1699922328228}, 'is-referenced-by-count': 0, 'issue': '45', 'issued': {'date-parts': [[2023, 11, 10]]}, 'journal-issue': {'issue': '45', 'published-print': {'date-parts': [[2023]]}}, 'language': 'en', 'license': [ { 'URL': 'http://creativecommons.org/licenses/by/4.0/', 'content-version': 'unspecified', 'delay-in-days': 0, 'start': { 'date-parts': [[2023, 11, 10]], 'date-time': '2023-11-10T00:00:00Z', 'timestamp': 1699574400000}}], 'link': [ { 'URL': 'https://journals.lww.com/10.1097/MD.0000000000035987', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'member': '276', 'original-title': [], 'page': 'e35987', 'prefix': '10.1097', 'published': {'date-parts': [[2023, 11, 10]]}, 'published-print': {'date-parts': [[2023, 11, 10]]}, 'publisher': 'Ovid Technologies (Wolters Kluwer Health)', 'reference': [ { 'DOI': '10.1016/j.ajem.2020.03.036', 'article-title': 'Coronavirus Disease (COVID-19): a primer for emergency physicians.', 'author': 'Chavez', 'doi-asserted-by': 'crossref', 'first-page': '220', 'journal-title': 'Am J Emerg Med', 'key': 'R2-20231113', 'volume': '44', 'year': '2021'}, { 'DOI': '10.1016/j.ajem.2022.01.028', 'article-title': 'Clinical update on COVID-19 for the emergency clinician: presentation ' 'and evaluation.', 'author': 'Long', 'doi-asserted-by': 'crossref', 'first-page': '46', 'journal-title': 'Am J Emerg Med', 'key': 'R3-20231113', 'volume': '54', 'year': '2022'}, { 'DOI': '10.1016/j.ijid.2021.11.009', 'article-title': 'Real-world effectiveness of COVID-19 vaccines: a literature review and ' 'meta-analysis.', 'author': 'Zheng', 'doi-asserted-by': 'crossref', 'first-page': '252', 'journal-title': 'Int J Infect Dis', 'key': 'R4-20231113', 'volume': '114', 'year': '2022'}, { 'article-title': 'SARS-CoV-2-neutralising monoclonal antibodies for treatment of ' 'COVID-19.', 'author': 'Kreuzberger', 'first-page': 'CD013825', 'journal-title': 'Cochrane Database Syst Rev', 'key': 'R5-20231113', 'volume': '9', 'year': '2021'}, { 'DOI': '10.1056/NEJMoa2102685', 'article-title': 'Bamlanivimab plus Etesevimab in mild or moderate Covid-19.', 'author': 'Dougan', 'doi-asserted-by': 'crossref', 'first-page': '1382', 'journal-title': 'N Engl J Med', 'key': 'R6-20231113', 'volume': '385', 'year': '2021'}, { '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.', 'author': 'Streinu-Cercel', 'doi-asserted-by': 'crossref', 'first-page': 'ofac053', 'journal-title': 'Open Forum Infect Dis', 'key': 'R8-20231113', 'volume': '9', 'year': '2022'}, { 'DOI': '10.3389/fimmu.2021.772320', 'article-title': 'Effectiveness of regdanvimab treatment in high-risk COVID-19 patients ' 'to prevent progression to severe disease Original Research.', 'author': 'Lee', 'doi-asserted-by': 'crossref', 'first-page': '772320', 'journal-title': 'Front Immunol', 'key': 'R10-20231113', 'volume': '12', 'year': '2021'}, { 'DOI': '10.3947/ic.2021.0143', 'article-title': 'Real world experience with regdanvimab treatment of mild-to-moderate ' 'coronavirus disease-19 in a COVID-19 designated hospital of Korea.', 'author': 'Hong', 'doi-asserted-by': 'crossref', 'first-page': '114', 'journal-title': 'Infect Chemother', 'key': 'R11-20231113', 'volume': '54', 'year': '2022'}, { 'DOI': '10.3390/jcm11051412', 'article-title': 'Real-world efficacy of regdanvimab on clinical outcomes in patients ' 'with mild to moderate COVID-19.', 'author': 'Kim', 'doi-asserted-by': 'crossref', 'first-page': '1412', 'journal-title': 'J Clin Med', 'key': 'R12-20231113', 'volume': '11', 'year': '2022'}, { '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.', 'author': 'Ryu', 'doi-asserted-by': 'crossref', 'first-page': '91', 'journal-title': 'Biochem Biophys Res Commun', 'key': 'R13-20231113', 'volume': '578', 'year': '2021'}, { 'DOI': '10.1136/bmj.m3379', 'article-title': 'A living WHO guideline on drugs for covid-19.', 'author': 'Agarwal', 'doi-asserted-by': 'crossref', 'first-page': 'm3379', 'journal-title': 'BMJ', 'key': 'R14-20231113', 'volume': '370', 'year': '2020'}, { 'DOI': '10.1007/s40265-021-01626-7', 'article-title': 'Regdanvimab: first approval.', 'author': 'Syed', 'doi-asserted-by': 'crossref', 'first-page': '2133', 'journal-title': 'Drugs', 'key': 'R15-20231113', 'volume': '81', 'year': '2021'}, { 'DOI': '10.3947/ic.2021.0303', 'article-title': 'Revised Korean Society of infectious diseases/national evidence-based ' 'healthcare collaborating agency guidelines on the treatment of patients ' 'with COVID-19.', 'author': 'Kim', 'doi-asserted-by': 'crossref', 'first-page': '166', 'journal-title': 'Infect Chemother', 'key': 'R16-20231113', 'volume': '53', 'year': '2021'}, { 'DOI': '10.1056/NEJMcp2009249', 'article-title': 'Mild or moderate Covid-19.', 'author': 'Gandhi', 'doi-asserted-by': 'crossref', 'first-page': '1757', 'journal-title': 'N Engl J Med', 'key': 'R17-20231113', 'volume': '383', 'year': '2020'}, { 'DOI': '10.3346/jkms.2021.36.e341', 'article-title': 'Clinical features of adult COVID-19 patients without risk factors ' 'before and after the Nationwide SARS-CoV-2 B.1.617.2 (Delta)-variant ' 'outbreak in Korea: experience from Gyeongsangnam-do.', 'author': 'Ryu', 'doi-asserted-by': 'crossref', 'first-page': 'e341', 'journal-title': 'J Korean Med Sci', 'key': 'R18-20231113', 'volume': '36', 'year': '2021'}, { 'DOI': '10.1016/j.jaci.2018.02.018', 'article-title': 'Hypersensitivity reactions to therapeutic monoclonal antibodies: ' 'Phenotypes and endotypes.', 'author': 'Isabwe', 'doi-asserted-by': 'crossref', 'first-page': '159', 'journal-title': 'J Allergy Clin Immunol', 'key': 'R20-20231113', 'volume': '142', 'year': '2018'}, { 'DOI': '10.1186/s12879-021-06376-1', 'article-title': 'COVID-19 viral load not associated with disease severity: findings from ' 'a retrospective cohort study.', 'author': 'Abdulrahman', 'doi-asserted-by': 'crossref', 'first-page': '688', 'journal-title': 'BMC Infect Dis', 'key': 'R21-20231113', 'volume': '21', 'year': '2021'}], 'reference-count': 17, 'references-count': 17, 'relation': {}, 'resource': {'primary': {'URL': 'https://journals.lww.com/10.1097/MD.0000000000035987'}}, 'score': 1, 'short-title': [], 'source': 'Crossref', 'subject': ['General Medicine'], 'subtitle': [], 'title': 'Clinical outcomes of mild to moderate coronavirus disease 2019 patients treated with Regdanvimab ' 'in delta-variant outbreak: Retrospective cohort study', 'type': 'journal-article', 'volume': '102'}