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

NCT ID: NCT04263402

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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2019-nCoV Severe Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Methylprednisolone(<40mg/d)

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(\<40mg/d intravenous drip for 7 days).

Methylprednisolone(40~80mg/d)

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

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

Interventions

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Methylprednisolone

Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(\<40mg/d intravenous drip for 7 days).

Intervention Type DRUG

Methylprednisolone

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qin Ning

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department and Institute of Infectious Disease

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qing Ning, Professor

Role: CONTACT

+8613971521450

Meifang Han, Professor

Role: CONTACT

+8613986093605

Facility Contacts

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Qin Ning, professor

Role: primary

Meifang Han, professor

Role: backup

Other Identifiers

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TJ20200201

Identifier Type: -

Identifier Source: org_study_id

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