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Clinical Trials/NCT04273321
NCT04273321
Completed
Not Applicable

Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails

Beijing Chao Yang Hospital7 sites in 1 country86 target enrollmentFebruary 14, 2020
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ConditionsCOVID-19Novel Coronavirus Pneumonia
InterventionsMethylprednisolone
DrugsMethylprednisolone

Overview

Phase
Not Applicable
Intervention
Methylprednisolone
Conditions
COVID-19
Sponsor
Beijing Chao Yang Hospital
Enrollment
86
Locations
7
Primary Endpoint
the incidence of treatment failure in 14 days
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2020
End Date
April 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Beijing Chao Yang Hospital
Responsible Party
Principal Investigator
Principal Investigator

Shi Huanzhong

Professor

Beijing Chao Yang Hospital

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

Arms & Interventions

MP group

Intervention: Methylprednisolone

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)

Study Sites (7)

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