The Standard of Care Combined With Glucocorticoid in Elderly People With Mild or Moderate COVID-19

Sponsor

Huashan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05855395

Collaborator

(none)

5,815

Enrollment

Locations

Arms

18.9

Anticipated Duration (Months)

387.7

Patients Per Site

20.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Glucocorticoid	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5815 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 5, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A 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)	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 Names: dexamethasone prednisone methylprednisolone
No Intervention: Group B 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.）

Arm

Intervention/Treatment

Experimental: Group A

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)

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 Names:

dexamethasone

prednisone

methylprednisolone

No Intervention: Group B

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.）

Outcome Measures

Primary Outcome Measures

Proportion of patients who progress to severe COVID-19 within 28 days [In 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 [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
Time for initial symptom relief，Duration of symptom relief [In 14 days]
Time for initial symptom relief (Date when symptoms were first reported as mild or asymptomatic), Duration of symptom relief(The date when symptoms were first reported as mild or asymptomatic, followed by remaining mild or asymptomatic until the 14th day）
All-cause mortality [In 28 days]
Short-term case fatality rate defined in the study, including case fatality on day 28
Days of respiratory symptoms [In 28 days]
Days of respiratory symptoms
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression [In 28 days]
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression
Length of hospital stay for any reason [In 28 days]
Length of hospital stay for any reason

Other Outcome Measures

ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected [In 14 days]
ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 65;
Male or female;
Positive test for coronavirus antigen or nucleic acid；
Within 7 days of onset (fever and/or cough) and Continuous high fever (> 39 °C) > 24h；
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 glucocorticoid 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350004
2	Quanzhou First Hospital	Quanzhou	Fujian	China	362000
3	The Fifth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510000
4	Attached Hospital of Zunyi Medical College	Zunyi	Guizhou	China	563099
5	Huaihua First People's Hospital	Huaihua	Hunan	China	418000
6	Nanjing Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu	China	210006
7	Affiliated Drum Tower Hospital, Medical School of Nanjing University	Nanjing	Jiangsu	China	210008
8	Wuxi Fifth People's Hospital	Wuxi	Jiangsu	China	214000
9	The People's Hospital Of Xingguo County	Ganzhou	Jiangxi	China	342400
10	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030000
11	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	China	646000
12	The First People's Hospital Of YunNan	Kunming	Yunnan	China	650100
13	People's Hospital of Qiubei County, Yunnan Province	Wenshan	Yunnan	China	663299
14	Hangzhou Linping District First People's Hospital	Hanzhou	Zhejiang	China	310000
15	Wenzhou Central Hospital	Wenzhou	Zhejiang	China	325099