NCT04273321CompletedNot Applicable
Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails
Beijing Chao Yang Hospital7 sites in 1 country86 target enrollmentStarted: February 14, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 7
- Primary Endpoint
- the incidence of treatment failure in 14 days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MP group
Experimental
Intervention: Methylprednisolone (Drug)
Outcomes
Primary Outcomes
the incidence of treatment failure in 14 days
Time Frame: 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 Outcomes
- 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)
Investigators
Shi Huanzhong
Professor
Beijing Chao Yang Hospital
Study Sites (7)
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