Official Title
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
Brief Summary

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.

Detailed Description

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.

Recruiting
COVID-19

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 65 Years ~ Maximum: N/A
Countries
China
Locations

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

Contacts

QiaoLing Ruan, M.D.
13661856002
ruan_qiao_ling@163.com

WenHong Zhang, M.D., Principal Investigator
Huashan Hospital

Huashan Hospital
NCT Number
Keywords
Glucocorticoids
standard of care
Mild and moderate COVID-19
MeSH Terms
COVID-19
Dexamethasone
Prednisone
Methylprednisolone
Glucocorticoids