The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19
- Registration Number
- NCT05855395
- Lead Sponsor
- Huashan Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5815
- 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；
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Glucocorticoid 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)
- Primary Outcome Measures
Name Time Method Proportion of patients who progress to severe or critical COVID-19 within 28 days In 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).
- Secondary Outcome Measures
Name Time Method Days of respiratory symptoms In 28 days Days of respiratory symptoms
Proportion of patients who progress to severe or critical COVID-19 within 28 days In 28 days Oxygen saturation ≤ 93% when inhaling air at rest
Length of hospital stay for any reason In 28 days Length of hospital stay for any reason
Duration of antigen or nucleic acid negative conversion In 28 days Duration of antigen or nucleic acid negative conversion
Day 14 antigen or nucleic acid conversion rate Day 14 Day 14 antigen or nucleic acid conversion rate
All-cause mortality In 28 days Short-term case fatality rate defined in the study, including case fatality on day 28
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment) In 28 days Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Proportion of emergency department visits or hospitalizations due to COVID-19 progression In 28 days 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 for initial symptom relief，Duration of symptom relief In 14 days 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）
Trial Locations
- Locations (15)
Affiliated Drum Tower Hospital, Medical School of Nanjing University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Huaihua First People's Hospital
🇨🇳Huaihua, Hunan, China
The People's Hospital Of Xingguo County
🇨🇳Ganzhou, Jiangxi, China
Quanzhou First Hospital
🇨🇳Quanzhou, Fujian, China
Attached Hospital of Zunyi Medical College
🇨🇳Zunyi, Guizhou, China
Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China
Hangzhou Linping District First People's Hospital
🇨🇳Hanzhou, Zhejiang, China
The Fifth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Wenzhou Central Hospital
🇨🇳Wenzhou, Zhejiang, China
Wuxi Fifth People's Hospital
🇨🇳Wuxi, Jiangsu, China
Nanjing Hospital of Traditional Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
The First People's Hospital Of YunNan
🇨🇳Kunming, Yunnan, China
People's Hospital of Qiubei County, Yunnan Province
🇨🇳Wenshan, Yunnan, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China