The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19
NCT ID: NCT05855395
Last Updated: 2023-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
5815 participants
INTERVENTIONAL
2023-05-26
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
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)
Glucocorticoid
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)
Group B
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.）
No interventions assigned to this group
Interventions
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Glucocorticoid
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female;
* Positive test for coronavirus antigen or nucleic acid；
* Within 7 days of onset (fever and/or cough) ；
* 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；
* 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)；
* No systemic glucocorticoids treatment in the past 7 days；
Exclusion Criteria
* Expected lifetime is less than 1 month；
* Severe/critical;
* Other situations that are evaluated by researchers as not suitable for participating the study.
Criteria for discontinuation
* The subject could not benefit after treatment (discontinued patients could be analyzed according to the PP analysis set);
Withdrawal criteria (if any of the following items are required)
* The subject asked to withdraw from the study;
* The subject needs to withdraw from the study after clinical observation after discontinuing treatment;
* The subject died or lost to follow-up.
65 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Wen-hong Zhang
Director of Division of Infectious Diseases Affiliation: Huashan Hospital
Principal Investigators
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WenHong Zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Quanzhou First Hospital
Quanzhou, Fujian, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Attached Hospital of Zunyi Medical College
Zunyi, Guizhou, China
Huaihua First People's Hospital
Huaihua, Hunan, China
Nanjing Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, China
The People's Hospital Of Xingguo County
Ganzhou, Jiangxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
The First People's Hospital Of YunNan
Kunming, Yunnan, China
People's Hospital of Qiubei County, Yunnan Province
Wenshan, Yunnan, China
Hangzhou Linping District First People's Hospital
Hanzhou, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yuekai Hu, M.D.
Role: primary
Xueping Yu, M.D.
Role: primary
Xi Liu, M.D.
Role: primary
Yuanbo Lan, M.D.
Role: primary
Hongying Yu, M.D.
Role: primary
Yanliang Zhang, M.D.
Role: primary
Chao Wu, M.D.
Role: primary
Feng Zhu, M.D.
Role: primary
Fei He, M.D.
Role: primary
Liaoyun Zhang, M.D.
Role: primary
Fuli Huang, M.D.
Role: primary
Jiawei Geng, M.D.
Role: primary
Lili Zhang, M.D.
Role: primary
XiaoQiang Zhang, M.D.
Role: primary
Jichan Shi, M.D.
Role: primary
References
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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.
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.
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.
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.
Related Links
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Guide：Diagnosis and Treatment Plan for COVID-19 (Tenth Edition on Trial)
Other Identifiers
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BEAT-COV
Identifier Type: -
Identifier Source: org_study_id
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