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

Phase 4

• Conditions: 2019-nCoV Severe Pneumonia
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT04263402
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-14
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone(<40mg/d)	Methylprednisolone	-
Methylprednisolone(40~80mg/d)	Methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
Rate and time of entering the critical stage	day 7	the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.
Rate of disease remission	day 7	For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2\>93% or PaO2/FiO2 \>300mmHg.

Secondary Outcome Measures

Name	Time	Method
Rate of normal tempreture	day 7	Rate of patients without fever at day 7
Rate of respiratory symptom remission	day 7	Rate of patients with respiratory symptom remission at day 7
Rate of laboratory indicator recovery	day 7	Rate of patients with laboratory indicator recovery at day 7
Rate of lung imaging recovery	day 7	Rate of patients with lung imaging recovery at day 7
Rate of undetectable viral RNA	day 7	Rate of patients withundetectable viral RNA at day 7

Trial Locations

Locations (1)

Department and Institute of Infectious Disease; 🇨🇳 Wuhan, Hubei, China