COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04263402
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : March 17, 2020
Information provided by (Responsible Party):
Qin Ning, 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.

Condition or disease Intervention/treatment Phase
2019-nCoV Severe Pneumonia Drug: Methylprednisolone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

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

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

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Rate of normal tempreture [ Time Frame: day 7 ]
    Rate of patients without fever at day 7

  2. Rate of respiratory symptom remission [ Time Frame: day 7 ]
    Rate of patients with respiratory symptom remission at day 7

  3. Rate of lung imaging recovery [ Time Frame: day 7 ]
    Rate of patients with lung imaging recovery at day 7

  4. Rate of laboratory indicator recovery [ Time Frame: day 7 ]
    Rate of patients with laboratory indicator recovery at day 7

  5. Rate of undetectable viral RNA [ Time Frame: day 7 ]
    Rate of patients withundetectable viral RNA at day 7

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04263402

Layout table for location contacts
Contact: Qing Ning, Professor +8613971521450
Contact: Meifang Han, Professor +8613986093605

Layout table for location information
China, Hubei
Department and Institute of Infectious Disease Recruiting
Wuhan, Hubei, China, 430030
Contact: Qin Ning, professor   
Contact: Meifang Han, professor   
Sponsors and Collaborators
Tongji Hospital

Layout table for additonal information
Responsible Party: Qin Ning, Professor, Tongji Hospital Identifier: NCT04263402    
Other Study ID Numbers: TJ20200201
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents