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

2019-nCoV Severe Pneumonia Clinical Trial

Official title:

An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263402
• Other study ID #: TJ20200201
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: Qing Ning, Professor
• Phone: +8613971521450
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 2019-nCoV Severe Pneumonia
• Pneumonia

Intervention

Drug:
• Methylprednisolone
Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days).
• Methylprednisolone
Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40~80mg/d intravenous drip for 7 days).

Locations

Country	Name	City	State
China	Department and Institute of Infectious Disease	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of disease remission	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.	day 7
Primary	Rate and time of entering the critical stage	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.	day 7
Secondary	Rate of normal tempreture	Rate of patients without fever at day 7	day 7
Secondary	Rate of respiratory symptom remission	Rate of patients with respiratory symptom remission at day 7	day 7
Secondary	Rate of lung imaging recovery	Rate of patients with lung imaging recovery at day 7	day 7
Secondary	Rate of laboratory indicator recovery	Rate of patients with laboratory indicator recovery at day 7	day 7
Secondary	Rate of undetectable viral RNA	Rate of patients withundetectable viral RNA at day 7	day 7