Back to resultsThe Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Glucocorticoid
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Glucocorticoids, Standard of care, Mild and moderate COVID-19
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.
Sites / Locations
- The First Affiliated Hospital of Fujian Medical University
- Quanzhou First Hospital
- The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- Attached Hospital of Zunyi Medical College
- Huaihua First People's HospitalRecruiting
- Nanjing Hospital of Traditional Chinese MedicineRecruiting
- Affiliated Drum Tower Hospital, Medical School of Nanjing University
- Wuxi Fifth People's HospitalRecruiting
- The People's Hospital Of Xingguo County
- The First Hospital of Shanxi Medical UniversityRecruiting
- Affiliated Hospital of Southwest Medical University
- The First People's Hospital Of YunNanRecruiting
- People's Hospital of Qiubei County, Yunnan ProvinceRecruiting
- Hangzhou Linping District First People's Hospital
- Wenzhou Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
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)
Control group with standard of care（The clinical standard of care of COVID-19 includes general treatment, oral antiviral drugs, immunotherapy, oxygen therapy and respiratory support, etc.）
Outcomes
Primary Outcome Measures
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Definition of severe COVID-19
At rest, oxygen saturation ≤ 93% when inhaling air;
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
Duration of antigen or nucleic acid negative conversion
Duration of antigen or nucleic acid negative conversion
Day 14 antigen or nucleic acid conversion rate
Day 14 antigen or nucleic acid conversion rate
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）
All-cause mortality
Short-term case fatality rate defined in the study, including case fatality on day 28
Days of respiratory symptoms
Days of respiratory symptoms
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Length of hospital stay for any reason
Length of hospital stay for any reason
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Oxygen saturation ≤ 93% when inhaling air at rest
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05855395
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Glucocorticoids, Standard of care, Mild and moderate COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5815 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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)
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Control group with standard of care（The clinical standard of care of COVID-19 includes general treatment, oral antiviral drugs, immunotherapy, oxygen therapy and respiratory support, etc.）
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid
Other Intervention Name(s)
dexamethasone, prednisone, methylprednisolone
Intervention Description
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 Measure Information:
Title
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Description
Definition of severe COVID-19
At rest, oxygen saturation ≤ 93% when inhaling air;
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
Secondary Outcome Measure Information:
Title
Duration of antigen or nucleic acid negative conversion
Description
Duration of antigen or nucleic acid negative conversion
Time Frame
In 28 days
Title
Day 14 antigen or nucleic acid conversion rate
Description
Day 14 antigen or nucleic acid conversion rate
Time Frame
Day 14
Title
Time for initial symptom relief，Duration of symptom relief
Description
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
Title
All-cause mortality
Description
Short-term case fatality rate defined in the study, including case fatality on day 28
Time Frame
In 28 days
Title
Days of respiratory symptoms
Description
Days of respiratory symptoms
Time Frame
In 28 days
Title
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Description
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Time Frame
In 28 days
Title
Length of hospital stay for any reason
Description
Length of hospital stay for any reason
Time Frame
In 28 days
Title
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Description
Oxygen saturation ≤ 93% when inhaling air at rest
Time Frame
In 28 days
Title
Proportion of emergency department visits or hospitalizations due to COVID-19 progression
Description
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
Other Pre-specified Outcome Measures:
Title
ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected
Description
ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected
Time Frame
In 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
QiaoLing Ruan, M.D.
Phone
13661856002
Email
ruan_qiao_ling@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WenHong Zhang, M.D.
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuekai Hu, M.D.
Facility Name
Quanzhou First Hospital
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueping Yu, M.D.
Facility Name
The Fifth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Liu, M.D.
Facility Name
Attached Hospital of Zunyi Medical College
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563099
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanbo Lan, M.D.
Facility Name
Huaihua First People's Hospital
City
Huaihua
State/Province
Hunan
ZIP/Postal Code
418000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongying Yu, M.D.
Facility Name
Nanjing Hospital of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanliang Zhang, M.D.
Facility Name
Affiliated Drum Tower Hospital, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Wu, M.D.
Facility Name
Wuxi Fifth People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Zhu, M.D.
Facility Name
The People's Hospital Of Xingguo County
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
342400
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei He, M.D.
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liaoyun Zhang, M.D.
Facility Name
Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuli Huang, M.D.
Facility Name
The First People's Hospital Of YunNan
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiawei Geng, M.D.
Facility Name
People's Hospital of Qiubei County, Yunnan Province
City
Wenshan
State/Province
Yunnan
ZIP/Postal Code
663299
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Zhang, M.D.
Phone
13619648406
Facility Name
Hangzhou Linping District First People's Hospital
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XiaoQiang Zhang, M.D.
Facility Name
Wenzhou Central Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325099
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jichan Shi, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After thesis defense the study will be published internationally to be available for the public.
IPD Sharing Time Frame
Data will be available within two year
IPD Sharing Access Criteria
Not yet
Citations:
PubMed Identifier
35144989
Citation
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Results Reference
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Links:
URL
http://www.gov.cn/xinwen/2023-01/06/content_5735357.htm
Description
Guide：Diagnosis and Treatment Plan for COVID-19 (Tenth Edition on Trial)
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The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19
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