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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,815
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)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGQuanzhou First Hospital
Quanzhou, Fujian, China
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Definition of severe COVID-19 1. At rest, oxygen saturation ≤ 93% when inhaling air; 2. 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).
Time frame: In 28 days
Duration of antigen or nucleic acid negative conversion
Duration of antigen or nucleic acid negative conversion
Time frame: In 28 days
Day 14 antigen or nucleic acid conversion rate
Day 14 antigen or nucleic acid conversion rate
Time frame: 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)
Time frame: In 14 days
All-cause mortality
Short-term case fatality rate defined in the study, including case fatality on day 28
Time frame: In 28 days
Days of respiratory symptoms
Days of respiratory symptoms
Time frame: In 28 days
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
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The Fifth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGAttached Hospital of Zunyi Medical College
Zunyi, Guizhou, China
NOT_YET_RECRUITINGHuaihua First People's Hospital
Huaihua, Hunan, China
RECRUITINGNanjing Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
RECRUITINGAffiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGWuxi Fifth People's Hospital
Wuxi, Jiangsu, China
RECRUITINGThe People's Hospital Of Xingguo County
Ganzhou, Jiangxi, China
NOT_YET_RECRUITINGThe First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
RECRUITING...and 5 more locations
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Time frame: In 28 days
Length of hospital stay for any reason
Length of hospital stay for any reason
Time frame: 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
Time frame: 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).
Time frame: In 28 days