Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-28 @ 11:16 PM
Study NCT ID:
NCT05855395
Status:
UNKNOWN
Last Update Posted:
2023-07-12
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005938', 'term': 'Glucocorticoids'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011239', 'term': 'Prednisolone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5815}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected', 'timeFrame': 'In 14 days', 'description': 'ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected'}], 'primaryOutcomes': [{'measure': 'Proportion of patients who progress to severe or critical COVID-19 within 28 days', 'timeFrame': 'In 28 days', 'description': 'Definition of severe COVID-19\n\n1. At rest, oxygen saturation ≤ 93% when inhaling air;\n2. Progression due to COVID-19 (defined as \\>50% of significant progression of lesions within 24\\~48 hours on lung imaging; or respiratory failure requiring mechanical ventilation; or emergency department visits or hospitalizations with shock) and/or complications (comitant other organ failure requiring intensive care unit monitoring).'}], 'secondaryOutcomes': [{'measure': 'Duration of antigen or nucleic acid negative conversion', 'timeFrame': 'In 28 days', 'description': 'Duration of antigen or nucleic acid negative conversion'}, {'measure': 'Day 14 antigen or nucleic acid conversion rate', 'timeFrame': 'Day 14', 'description': 'Day 14 antigen or nucleic acid conversion rate'}, {'measure': 'Time for initial symptom relief，Duration of symptom relief', 'timeFrame': 'In 14 days', 'description': 'Time for initial all symptoms relief (Date when symptoms were first reported as mild or asymptomatic), Duration of all symptoms relief(The date when all symptoms were first reported as mild or asymptomatic, followed by remaining mild or asymptomatic until the 14th day）'}, {'measure': 'All-cause mortality', 'timeFrame': 'In 28 days', 'description': 'Short-term case fatality rate defined in the study, including case fatality on day 28'}, {'measure': 'Days of respiratory symptoms', 'timeFrame': 'In 28 days', 'description': 'Days of respiratory symptoms'}, {'measure': 'Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)', 'timeFrame': 'In 28 days', 'description': 'Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)'}, {'measure': 'Length of hospital stay for any reason', 'timeFrame': 'In 28 days', 'description': 'Length of hospital stay for any reason'}, {'measure': 'Proportion of patients who progress to severe or critical COVID-19 within 28 days', 'timeFrame': 'In 28 days', 'description': 'Oxygen saturation ≤ 93% when inhaling air at rest'}, {'measure': 'Proportion of emergency department visits or hospitalizations due to COVID-19 progression', 'timeFrame': 'In 28 days', 'description': 'Progression due to COVID-19 (defined as \\>50% of significant progression of lesions within 24\\~48 hours on lung imaging; or respiratory failure requiring mechanical ventilation; or emergency department visits or hospitalizations with shock) and/or complications (comitant other organ failure requiring intensive care unit monitoring).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucocorticoids', 'Standard of care', 'Mild and moderate COVID-19'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '35144989', 'type': 'BACKGROUND', 'citation': 'Agusti A, De Stefano G, Levi A, Munoz X, Romero-Mesones C, Sibila O, Lopez-Giraldo A, Plaza Moral V, Curto E, Echazarreta AL, Marquez SE, Pascual-Guardia S, Santos S, Marin A, Valdes L, Saldarini F, Salgado C, Casanovas G, Varea S, Rios J, Faner R. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial. Eur Respir J. 2022 Mar 10;59(3):2103036. doi: 10.1183/13993003.03036-2021. Print 2022 Mar.'}, {'pmid': '34441840', 'type': 'BACKGROUND', 'citation': 'Song JY, Yoon JG, Seo YB, Lee J, Eom JS, Lee JS, Choi WS, Lee EY, Choi YA, Hyun HJ, Seong H, Noh JY, Cheong HJ, Kim WJ. Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 Trial. J Clin Med. 2021 Aug 12;10(16):3545. doi: 10.3390/jcm10163545.'}, {'pmid': '32887691', 'type': 'BACKGROUND', 'citation': 'Agarwal A, Hunt B, Stegemann M, Rochwerg B, Lamontagne F, Siemieniuk RA, Agoritsas T, Askie L, Lytvyn L, Leo YS, Macdonald H, Zeng L, Alhadyan A, Muna A, Amin W, da Silva ARA, Aryal D, Barragan FAJ, Bausch FJ, Burhan E, Calfee CS, Cecconi M, Chacko B, Chanda D, Dat VQ, De Sutter A, Du B, Freedman S, Geduld H, Gee P, Haider M, Gotte M, Harley N, Hashimi M, Hui D, Ismail M, Jehan F, Kabra SK, Kanda S, Kim YJ, Kissoon N, Krishna S, Kuppalli K, Kwizera A, Lado Castro-Rial M, Lisboa T, Lodha R, Mahaka I, Manai H, Mendelson M, Migliori GB, Mino G, Nsutebu E, Peter J, Preller J, Pshenichnaya N, Qadir N, Ranganathan SS, Relan P, Rylance J, Sabzwari S, Sarin R, Shankar-Hari M, Sharland M, Shen Y, Souza JP, Swanstrom R, Tshokey T, Ugarte S, Uyeki T, Evangelina VC, Venkatapuram S, Vuyiseka D, Wijewickrama A, Tran L, Zeraatkar D, Bartoszko JJ, Ge L, Brignardello-Petersen R, Owen A, Guyatt G, Diaz J, Kawano-Dourado L, Jacobs M, Vandvik PO. A living WHO guideline on drugs for covid-19. BMJ. 2020 Sep 4;370:m3379. doi: 10.1136/bmj.m3379.'}, {'pmid': '33474730', 'type': 'BACKGROUND', 'citation': 'Orchard K, Dignan FL, Lee J, Pearce R, Desai M, McFarlane E, Parkin A, Shearn P, Snowden JA. The NICE COVID-19 rapid guideline on haematopoietic stem cell transplantation: development, implementation and impact. Br J Haematol. 2021 Feb;192(3):467-473. doi: 10.1111/bjh.17280. Epub 2021 Jan 20. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.gov.cn/xinwen/2023-01/06/content_5735357.htm', 'label': 'Guide：Diagnosis and Treatment Plan for COVID-19 (Tenth Edition on Trial)'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed to explore the dual-dimensional early intervention strategy of standard of care combined with host immunomodulation in elderly patients with mild and moderate COVID-19.', 'detailedDescription': 'In this multicentre, randomized, controlled, and adaptive platform trial exploring the efficacy and safety of short-term and low-dose glucocorticoid combined with standard of care in mild or moderate elderly patients (with or without other high-risk factors) who are over 65 years.We are looking for the best treatment strategy to prevent mild or moderate COVID-19 from developing into severe/critical COVID-19, so as to reduce the risk of disease progression and death in the elderly patients and benefit more patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 65;\n* Male or female;\n* Positive test for coronavirus antigen or nucleic acid；\n* Within 7 days of onset (fever and/or cough) ；\n* mild and moderate；Mild: respiratory tract infection is the main manifestation, such as dry throat, sore throat, cough, fever；Moderate: continuous high fever\\>3 days or (and) cough, shortness of breath, etc., but respiratory rate (RR)\\<30 times/minute, oxygen saturation\\>93% when breathing air at rest. Imaging findings of characteristic pneumonia caused by COVID-19 infection；\n* The patient is willing to participate in the trial treatment and follow-up, and sign the informed consent form (if the patient lacks the ability to give informed consent due to his serious medical condition, such as acute respiratory failure or the need for respiratory support, he can obtain the consent of the patient's legal representative)；\n* No systemic glucocorticoids treatment in the past 7 days；\n\nExclusion Criteria:\n\n* Serious and uncontrolled comorbidities；\n* Expected lifetime is less than 1 month；\n* Severe/critical;\n* Other situations that are evaluated by researchers as not suitable for participating the study.\n\nCriteria for discontinuation\n\n* The subject could not benefit after treatment (discontinued patients could be analyzed according to the PP analysis set);\n\nWithdrawal criteria (if any of the following items are required)\n\n* The subject asked to withdraw from the study;\n* The subject needs to withdraw from the study after clinical observation after discontinuing treatment;\n* The subject died or lost to follow-up."}, 'identificationModule': {'nctId': 'NCT05855395', 'briefTitle': 'The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'A Bidimensional Early Intervention Strategy of Standard of Care Combined With Host Immunomodulation in Elderly Patients With Mild or Moderate COVID-19: A Multicentre, Randomized, Controlled, Adaptive Platform Study', 'orgStudyIdInfo': {'id': 'BEAT-COV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Experimental group with standard of care combined with glucocorticoid（dexamethasone: 3mg qd x 5 days; or prednisone: 20mg qd x 5 days; or methylprednisolone: 16mg qd x 5 days)', 'interventionNames': ['Drug: Glucocorticoid']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': 'Control group with standard of care（The clinical standard of care of COVID-19 includes general treatment, oral antiviral drugs, immunotherapy, oxygen therapy and respiratory support, etc.）'}], 'interventions': [{'name': 'Glucocorticoid', 'type': 'DRUG', 'otherNames': ['dexamethasone', 'prednisone', 'methylprednisolone'], 'description': 'standard of care combined with glucocorticoid(dexamethasone: 3mg qd x 5 days; or prednisone: 20mg qd x 5 days; or methylprednisolone: 16mg qd x 5 days)', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350004', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuekai Hu, M.D.', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '362000', 'city': 'Quanzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueping Yu, M.D.', 'role': 'CONTACT'}], 'facility': 'Quanzhou First Hospital', 'geoPoint': {'lat': 24.91389, 'lon': 118.58583}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Liu, M.D.', 'role': 'CONTACT'}], 'facility': 'The Fifth Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '563099', 'city': 'Zunyi', 'state': 'Guizhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanbo Lan, M.D.', 'role': 'CONTACT'}], 'facility': 'Attached Hospital of Zunyi Medical College', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'zip': '418000', 'city': 'Huaihua', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongying Yu, M.D.', 'role': 'CONTACT'}], 'facility': "Huaihua First People's Hospital", 'geoPoint': {'lat': 27.56337, 'lon': 110.00404}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanliang Zhang, M.D.', 'role': 'CONTACT'}], 'facility': 'Nanjing Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chao Wu, M.D.', 'role': 'CONTACT'}], 'facility': 'Affiliated Drum Tower Hospital, Medical School of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '214000', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Zhu, M.D.', 'role': 'CONTACT'}], 'facility': "Wuxi Fifth People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '342400', 'city': 'Ganzhou', 'state': 'Jiangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei He, M.D.', 'role': 'CONTACT'}], 'facility': "The People's Hospital Of Xingguo County", 'geoPoint': {'lat': 25.84664, 'lon': 114.9326}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liaoyun Zhang, M.D.', 'role': 'CONTACT'}], 'facility': 'The First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '646000', 'city': 'Luzhou', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fuli Huang, M.D.', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Southwest Medical University', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'zip': '650100', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiawei Geng, M.D.', 'role': 'CONTACT'}], 'facility': "The First People's Hospital Of YunNan", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '663299', 'city': 'Wenshan', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lili Zhang, M.D.', 'role': 'CONTACT', 'phone': '13619648406'}], 'facility': "People's Hospital of Qiubei County, Yunnan Province", 'geoPoint': {'lat': 24.3232, 'lon': 102.211}}, {'zip': '310000', 'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'XiaoQiang Zhang, M.D.', 'role': 'CONTACT'}], 'facility': "Hangzhou Linping District First People's Hospital"}, {'zip': '325099', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jichan Shi, M.D.', 'role': 'CONTACT'}], 'facility': 'Wenzhou Central Hospital', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'QiaoLing Ruan, M.D.', 'role': 'CONTACT', 'email': 'ruan_qiao_ling@163.com', 'phone': '13661856002'}], 'overallOfficials': [{'name': 'WenHong Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within two year', 'ipdSharing': 'YES', 'description': 'After thesis defense the study will be published internationally to be available for the public.', 'accessCriteria': 'Not yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Division of Infectious Diseases Affiliation: Huashan Hospital', 'investigatorFullName': 'Wen-hong Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}