Efficacy and Safety of Corticosteroids in COVID-19

Not Applicable

Completed

• Conditions: Novel Coronavirus Pneumonia; COVID-19
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT04273321
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-14
• Study First Submitted: 2020-02-15
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-18
• Status Verified: 2020-04
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MP group	Methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
the incidence of treatment failure in 14 days	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

Name	Time	Method
clinical cure incidence in 14 days	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	30 days	the duration from admission to virus negative
mortality at day 30	30 days	the patient die in 30 days
ICU admission rate in 30 days	30 days	the patients transform to ICU because of clinical deteriorate in 30 days

Trial Locations

Locations (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