The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia
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|ClinicalTrials.gov Identifier: NCT04263402|
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|2019-nCoV Severe Pneumonia||Drug: Methylprednisolone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days).
Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40~80mg/d intravenous drip for 7 days).
- Rate of disease remission [ Time Frame: 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.
- Rate and time of entering the critical stage [ Time Frame: 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 normal tempreture [ Time Frame: day 7 ]Rate of patients without fever at day 7
- Rate of respiratory symptom remission [ Time Frame: day 7 ]Rate of patients with respiratory symptom remission at day 7
- Rate of lung imaging recovery [ Time Frame: day 7 ]Rate of patients with lung imaging recovery at day 7
- Rate of laboratory indicator recovery [ Time Frame: day 7 ]Rate of patients with laboratory indicator recovery at day 7
- Rate of undetectable viral RNA [ Time Frame: day 7 ]Rate of patients withundetectable viral RNA at day 7
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04263402
|Contact: Qing Ning, Professorfirstname.lastname@example.org|
|Contact: Meifang Han, Professoremail@example.com|