The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia

Tongji Hospital

Status and phase: Unknown; Phase 4

Conditions: 2019-nCoV Severe Pneumonia

Treatments: Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT04263402

TJ20200201

Details and patient eligibility

About

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1.Meet the definition of severe pneumonia(Comply with any of the followings):

1. Shortness of breath,RR≥30 bpm;
2. In a resting state:SPO2≤93%;
3. PaO2/FiO2≤300mmHg.

2.2019-nCoV nucleic acid test was positive.

3.CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion criteria

1. dying state (i.e. survival time is less than 24 hours);
2. progressive malignant tumor with life expectancy less than 6 months;
3. immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
4. underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
5. pregnancy
6. patients with glucocorticoid taboos

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Methylprednisolone(<40mg/d)

Experimental group

Treatment:

Drug: Methylprednisolone

Drug: Methylprednisolone

Methylprednisolone(40~80mg/d)

Experimental group

Treatment:

Drug: Methylprednisolone

Drug: Methylprednisolone