COVID-19, Novel Coronavirus Pneumonia
Conditions
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.
Interventions
DRUGMethylprednisolone
Methylprednisolone 1mg/kg/day ivgtt for 7 days.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed