This study is aimed to explore the dual-dimensional early intervention strategy ofstandard of care combined with host immunomodulation in elderly patients with mild andmoderate 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.
Drug: 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 Name: dexamethasone,prednisone,methylprednisolone
Inclusion Criteria:
- Age ≥ 65;
- 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:
- Serious and uncontrolled comorbidities;
- 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.
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
QiaoLing Ruan, M.D.
13661856002
ruan_qiao_ling@163.com
WenHong Zhang, M.D., Principal Investigator
Huashan Hospital