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

July 11, 2023 updated by: Wen-hong Zhang, Huashan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

5815

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • Not yet recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Yuekai Hu, M.D.
      • Quanzhou, Fujian, China, 362000
        • Not yet recruiting
        • Quanzhou First Hospital
        • Contact:
          • Xueping Yu, M.D.
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The fifth affiliated hospital of sun yat-sen university
        • Contact:
          • Xi Liu, M.D.
    • Guizhou
      • Zunyi, Guizhou, China, 563099
        • Not yet recruiting
        • Attached Hospital of Zunyi Medical College
        • Contact:
          • Yuanbo Lan, M.D.
    • Hunan
      • Huaihua, Hunan, China, 418000
        • Recruiting
        • Huaihua First People's Hospital
        • Contact:
          • Hongying Yu, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing Hospital of Traditional Chinese Medicine
        • Contact:
          • Yanliang Zhang, M.D.
      • Nanjing, Jiangsu, China, 210008
        • Not yet recruiting
        • Affiliated Drum Tower Hospital, Medical School of Nanjing University
        • Contact:
          • Chao Wu, M.D.
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Wuxi Fifth People's Hospital
        • Contact:
          • Feng Zhu, M.D.
    • Jiangxi
      • Ganzhou, Jiangxi, China, 342400
        • Not yet recruiting
        • The People's Hospital Of Xingguo County
        • Contact:
          • Fei He, M.D.
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:
          • Liaoyun Zhang, M.D.
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • Not yet recruiting
        • Affiliated Hospital of Southwest Medical University
        • Contact:
          • Fuli Huang, M.D.
    • Yunnan
      • Kunming, Yunnan, China, 650100
        • Recruiting
        • The First People's Hospital of Yunnan
        • Contact:
          • Jiawei Geng, M.D.
      • Wenshan, Yunnan, China, 663299
        • Recruiting
        • People's Hospital of Qiubei County, Yunnan Province
        • Contact:
          • Lili Zhang, M.D.
          • Phone Number: 13619648406
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Hangzhou Linping District first People's Hospital
        • Contact:
          • XiaoQiang Zhang, M.D.
      • Wenzhou, Zhejiang, China, 325099
        • Not yet recruiting
        • Wenzhou Central Hospital
        • Contact:
          • Jichan Shi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
  • methylprednisolone
  • prednisone
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.）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Time Frame: 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).
In 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of antigen or nucleic acid negative conversion
Time Frame: In 28 days
Duration of antigen or nucleic acid negative conversion
In 28 days
Day 14 antigen or nucleic acid conversion rate
Time Frame: Day 14
Day 14 antigen or nucleic acid conversion rate
Day 14
All-cause mortality
Time Frame: In 28 days
Short-term case fatality rate defined in the study, including case fatality on day 28
In 28 days
Days of respiratory symptoms
Time Frame: In 28 days
Days of respiratory symptoms
In 28 days
Length of hospital stay for any reason
Time Frame: In 28 days
Length of hospital stay for any reason
In 28 days
Time for initial symptom relief，Duration of symptom relief
Time Frame: 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）
In 14 days
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
Time Frame: In 28 days
Duration of outpatient hospitalization/emergency department visits due to COVID-19 progression(from the date of enrollment)
In 28 days
Proportion of patients who progress to severe or critical COVID-19 within 28 days
Time Frame: In 28 days
Oxygen saturation ≤ 93% when inhaling air at rest
In 28 days
Proportion of emergency department visits or hospitalizations due to COVID-19 progression
Time Frame: 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).
In 28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected
Time Frame: In 14 days
ADRs and SADRs associated with glucocorticoid therapy and antiviral therapy（One of the standard treatments) were collected
In 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Wenhong Zhang, M.D., Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEAT-COV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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