Efficacy and Safety of Corticosteroids in COVID-19
1 other identifier
interventional
86
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Feb 2020
Shorter than P25 for not_applicable covid19
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2020
CompletedFirst Submitted
Initial submission to the registry
February 15, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2020
CompletedMay 11, 2020
April 1, 2020
2 months
February 15, 2020
May 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
14 days
Secondary Outcomes (4)
clinical cure incidence in 14 days
14 days
the duration of virus change to negative
30 days
mortality at day 30
30 days
ICU admission rate in 30 days
30 days
Study Arms (2)
MP group
EXPERIMENTALCon group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hubei province hospital of integrated Chinese & Western Medicine
Wuhan, Hubei, China
Yichang first people's Hospital
Yichang, Hubei, China
Beijing YouAn Hospital
Beijing, China
Renmin Hospital of Wuhan University
Wuhan, China
Tianyou Hospital Affiliated to Wuhan University of science and technology
Wuhan, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan, China
the first peopel hospital of Xiangyang
Xiangyang, China
Related Publications (1)
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.
PMID: 33486496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 15, 2020
First Posted
February 18, 2020
Study Start
February 14, 2020
Primary Completion
April 15, 2020
Study Completion
April 15, 2020
Last Updated
May 11, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR