Efficacy and Safety of Corticosteroids in COVID-19

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04273321

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

12.3

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Novel Coronavirus Pneumonia	Drug: Methylprednisolone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 14, 2020

Actual Primary Completion Date :

Apr 15, 2020

Actual Study Completion Date :

Apr 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MP group	Drug: Methylprednisolone Methylprednisolone 1mg/kg/day ivgtt for 7 days.
No Intervention: Con group

Arm

Intervention/Treatment

Experimental: MP group

Drug: Methylprednisolone

Methylprednisolone 1mg/kg/day ivgtt for 7 days.

No Intervention: Con group

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Hubei province hospital of integrated Chinese & Western Medicine	Wuhan	Hubei	China
2	Yichang first people's Hospital	Yichang	Hubei	China
3	Beijing YouAn Hospital	Beijing		China
4	Renmin Hospital of Wuhan University	Wuhan		China
5	Tianyou Hospital Affiliated to Wuhan University of science and technology	Wuhan		China
6	Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology	Wuhan		China
7	the first peopel hospital of Xiangyang	Xiangyang		China