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

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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):
- Shortness of breath,RR≥30 bpm;
- In a resting state:SPO2≤93%;
- 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:
- dying state (i.e. survival time is less than 24 hours);
- progressive malignant tumor with life expectancy less than 6 months;
- immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
- underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
- pregnancy
- patients with glucocorticoid taboos

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, Professor | +8613971521450 | qning@vip.sina.com | |
Contact: Meifang Han, Professor | +8613986093605 | mfhan@foxmail.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |