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Efficacy and Safety of Corticosteroids in COVID-19

Primary Purpose

COVID-19, Novel Coronavirus Pneumonia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age more than 18 years old
  • accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19).
  • admitted in the general wards
  • be able to sign informed consent

Exclusion Criteria:

  • severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
  • pregnant or lactation period women
  • glucocorticoids are needed for other diseases
  • unwilling or unable to participate or complete the study
  • participate in other study

Sites / Locations

  • Hubei province hospital of integrated Chinese & Western Medicine
  • Yichang first people's Hospital
  • Beijing YouAn Hospital
  • Renmin Hospital of Wuhan University
  • Tianyou Hospital Affiliated to Wuhan University of science and technology
  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
  • the first peopel hospital of Xiangyang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MP group

Con group

Arm Description

Outcomes

Primary Outcome Measures

the incidence of treatment failure in 14 days
The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.

Secondary Outcome Measures

clinical cure incidence in 14 days
The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.
the duration of virus change to negative
the duration from admission to virus negative
mortality at day 30
the patient die in 30 days
ICU admission rate in 30 days
the patients transform to ICU because of clinical deteriorate in 30 days

Full Information

First Posted
February 15, 2020
Last Updated
May 8, 2020
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04273321
Brief Title
Efficacy and Safety of Corticosteroids in COVID-19
Official Title
Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Novel Coronavirus Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP group
Arm Type
Experimental
Arm Title
Con group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednisolone 1mg/kg/day ivgtt for 7 days.
Primary Outcome Measure Information:
Title
the incidence of treatment failure in 14 days
Description
The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
clinical cure incidence in 14 days
Description
The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.
Time Frame
14 days
Title
the duration of virus change to negative
Description
the duration from admission to virus negative
Time Frame
30 days
Title
mortality at day 30
Description
the patient die in 30 days
Time Frame
30 days
Title
ICU admission rate in 30 days
Description
the patients transform to ICU because of clinical deteriorate in 30 days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age more than 18 years old accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19). admitted in the general wards be able to sign informed consent Exclusion Criteria: severe immunosuppression (HIV infection, long-term use of immunosuppressive agents pregnant or lactation period women glucocorticoids are needed for other diseases unwilling or unable to participate or complete the study participate in other study
Facility Information:
Facility Name
Hubei province hospital of integrated Chinese & Western Medicine
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Yichang first people's Hospital
City
Yichang
State/Province
Hubei
Country
China
Facility Name
Beijing YouAn Hospital
City
Beijing
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
Country
China
Facility Name
Tianyou Hospital Affiliated to Wuhan University of science and technology
City
Wuhan
Country
China
Facility Name
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
City
Wuhan
Country
China
Facility Name
the first peopel hospital of Xiangyang
City
Xiangyang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33486496
Citation
Tang X, Feng YM, Ni JX, Zhang JY, Liu LM, Hu K, Wu XZ, Zhang JX, Chen JW, Zhang JC, Su J, Li YL, Zhao Y, Xie J, Ding Z, He XL, Wang W, Jin RH, Shi HZ, Sun B. Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial. Respiration. 2021;100(2):116-126. doi: 10.1159/000512063. Epub 2021 Jan 22.
Results Reference
derived

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Efficacy and Safety of Corticosteroids in COVID-19

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