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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.
 
ClinicalTrials.gov Identifier: NCT04263402
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : March 17, 2020
Sponsor:
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

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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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04263402


Contacts
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Contact: Qing Ning, Professor +8613971521450 qning@vip.sina.com
Contact: Meifang Han, Professor +8613986093605 mfhan@foxmail.com

Locations
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China, Hubei
Department and Institute of Infectious Disease Recruiting
Wuhan, Hubei, China, 430030
Contact: Qin Ning, professor       qning@vip.sina.com   
Contact: Meifang Han, professor       mfhan@foxmail.com   
Sponsors and Collaborators
Tongji Hospital

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Responsible Party: Qin Ning, Professor, Tongji Hospital
ClinicalTrials.gov 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

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