Efficacy and Safety of Corticosteroids in COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273321
• Other study ID #: Methylprednisolone in COVID-19
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: April 15, 2020

Study information

• Verified date: April 2020
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Novel Coronavirus Pneumonia
• Pneumonia

Intervention

Drug:
• Methylprednisolone
Methylprednisolone 1mg/kg/day ivgtt for 7 days.

Locations

Country	Name	City	State
China	Beijing YouAn Hospital	Beijing
China	Hubei province hospital of integrated Chinese & Western Medicine	Wuhan	Hubei
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	Yichang first people's Hospital	Yichang	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	14 days
Secondary	the duration of virus change to negative	the duration from admission to virus negative	30 days
Secondary	mortality at day 30	the patient die in 30 days	30 days
Secondary	ICU admission rate in 30 days	the patients transform to ICU because of clinical deteriorate in 30 days	30 days