Clinical trial NCT05855395: The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: Glucocorticoids
Standard of care
Mild and moderate COVID-19
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 5815
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of patients who progress to severe or critical COVID-19 within 28 days
timeFrame: In 28 days
Secondary outcomes:
measure: Duration of antigen or nucleic acid negative conversion
timeFrame: In 28 days
measure: Day 14 antigen or nucleic acid conversion rate
timeFrame: Day 14
measure: Time for initial symptom relief，Duration of symptom relief
timeFrame: In 14 days
measure: All-cause mortality
timeFrame: In 28 days
measure: Days of respiratory symptoms
timeFrame: In 28 days
measure: Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
timeFrame: In 28 days
measure: Length of hospital stay for any reason
timeFrame: In 28 days
measure: Proportion of patients who progress to severe or critical COVID-19 within 28 days
timeFrame: In 28 days
measure: Proportion of emergency department visits or hospitalizations due to COVID-19 progression
timeFrame: In 28 days
Other outcomes:
measure: ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected
timeFrame: In 14 days
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital
state: Fujian
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zunyi
country: China
facility: Attached Hospital of Zunyi Medical College
state: Guizhou
city: Huaihua
country: China
facility: Huaihua First People's Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Fifth People's Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: The People's Hospital Of Xingguo County
state: Jiangxi
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Luzhou
country: China
facility: Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Kunming
country: China
facility: The First People's Hospital Of YunNan
state: Yunnan
city: Wenshan
country: China
facility: People's Hospital of Qiubei County, Yunnan Province
state: Yunnan
city: Hanzhou
country: China
facility: Hangzhou Linping District First People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Huashan Hospital
name: WenHong Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
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