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Efficacy and Safety of Corticosteroids in COVID-19

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04273321
Recruitment Status : Completed
First Posted : February 18, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Shi Huanzhong, Beijing Chao Yang Hospital

Study Description
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Brief Summary:
There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.

Condition or disease Intervention/treatment Phase
COVID-19 Novel Coronavirus Pneumonia Drug: Methylprednisolone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails
Actual Study Start Date : February 14, 2020
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MP group Drug: Methylprednisolone
Methylprednisolone 1mg/kg/day ivgtt for 7 days.
No Intervention: Con group


Outcome Measures
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Primary Outcome Measures :
  1. the incidence of treatment failure in 14 days [ Time Frame: 14 days ]
    The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.


Secondary Outcome Measures :
  1. clinical cure incidence in 14 days [ Time Frame: 14 days ]
    The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.

  2. the duration of virus change to negative [ Time Frame: 30 days ]
    the duration from admission to virus negative

  3. mortality at day 30 [ Time Frame: 30 days ]
    the patient die in 30 days

  4. ICU admission rate in 30 days [ Time Frame: 30 days ]
    the patients transform to ICU because of clinical deteriorate in 30 days


Eligibility Criteria
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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:

  • age more than 18 years old
  • accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19).
  • admitted in the general wards
  • be able to sign informed consent

Exclusion Criteria:

  • severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
  • pregnant or lactation period women
  • glucocorticoids are needed for other diseases
  • unwilling or unable to participate or complete the study
  • participate in other study
Contacts and Locations
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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): NCT04273321


Locations
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China, Hubei
Hubei province hospital of integrated Chinese & Western Medicine
Wuhan, Hubei, China
Yichang first people's Hospital
Yichang, Hubei, China
China
Beijing YouAn Hospital
Beijing, China
Renmin Hospital of Wuhan University
Wuhan, China
Tianyou Hospital Affiliated to Wuhan University of science and technology
Wuhan, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan, China
the first peopel hospital of Xiangyang
Xiangyang, China
Sponsors and Collaborators
Beijing Chao Yang Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shi Huanzhong, Professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04273321    
Other Study ID Numbers: Methylprednisolone in COVID-19
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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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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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
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