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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 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) |
|
| Group B | No Intervention | 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.） |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoid | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who progress to severe or critical COVID-19 within 28 days | Definition of severe COVID-19
| In 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of antigen or nucleic acid negative conversion | Duration of antigen or nucleic acid negative conversion | In 28 days |
| Day 14 antigen or nucleic acid conversion rate | Day 14 antigen or nucleic acid conversion rate |
| Measure | Description | Time Frame |
|---|---|---|
| ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected | ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected | In 14 days |
Inclusion Criteria:
Exclusion Criteria:
Criteria for discontinuation
Withdrawal criteria (if any of the following items are required)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| QiaoLing Ruan, M.D. | Contact | 13661856002 | ruan_qiao_ling@163.com |
| Name | Affiliation | Role |
|---|---|---|
| WenHong Zhang, M.D. | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35144989 | Background | 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. | |
| 34441840 |
| Label | URL |
|---|---|
| Guide：Diagnosis and Treatment Plan for COVID-19 (Tenth Edition on Trial) | View source |
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After thesis defense the study will be published internationally to be available for the public.
Data will be available within two year
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| D003907 | Dexamethasone |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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|
| Day 14 |
| Time for initial symptom relief，Duration of symptom relief | 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） | In 14 days |
| All-cause mortality | Short-term case fatality rate defined in the study, including case fatality on day 28 | In 28 days |
| Days of respiratory symptoms | Days of respiratory symptoms | In 28 days |
| Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment) | Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment) | In 28 days |
| Length of hospital stay for any reason | Length of hospital stay for any reason | In 28 days |
| Proportion of patients who progress to severe or critical COVID-19 within 28 days | Oxygen saturation ≤ 93% when inhaling air at rest | In 28 days |
| Proportion of emergency department visits or hospitalizations due to COVID-19 progression | 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). | In 28 days |
| Quanzhou First Hospital | Not yet recruiting | Quanzhou | Fujian | 362000 | China |
|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
|
| Attached Hospital of Zunyi Medical College | Not yet recruiting | Zunyi | Guizhou | 563099 | China |
|
| Huaihua First People's Hospital | Recruiting | Huaihua | Hunan | 418000 | China |
|
| Nanjing Hospital of Traditional Chinese Medicine | Recruiting | Nanjing | Jiangsu | 210006 | China |
|
| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
|
| Wuxi Fifth People's Hospital | Recruiting | Wuxi | Jiangsu | 214000 | China |
|
| The People's Hospital Of Xingguo County | Not yet recruiting | Ganzhou | Jiangxi | 342400 | China |
|
| The First Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
|
| The First People's Hospital Of YunNan | Recruiting | Kunming | Yunnan | 650100 | China |
|
| People's Hospital of Qiubei County, Yunnan Province | Recruiting | Wenshan | Yunnan | 663299 | China |
|
| Hangzhou Linping District First People's Hospital | Not yet recruiting | Hanzhou | Zhejiang | 310000 | China |
|
| Wenzhou Central Hospital | Not yet recruiting | Wenzhou | Zhejiang | 325099 | China |
|
| Background |
| 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. |
| 32887691 | Background | 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. |
| 33474730 | Background | 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. |
| 41792630 | Derived | Ruan Q, Zhang Y, Zhao T, Zhu F, Liu X, Cao R, Li Y, Zhang X, Song W, Geng J, Zou D, Li Y, Zhang L, Wu C, Lan Y, Ding X, Huang F, Wu J, Sun F, Shao L, Zhang W. A bidimensional early intervention strategy of standard of care in combination with corticosteroids in elderly patients with mild to moderate COVID-19 (BEAT-COV study): a multicentre, open-label, randomized controlled trial. BMC Infect Dis. 2026 Mar 6;26(1):758. doi: 10.1186/s12879-026-12637-8. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011244 | Pregnadienediols |
| D011239 | Prednisolone |