Efficacy and Safety of Corticosteroids in COVID-19

NCT ID: NCT04273321

Last Updated: 2020-05-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2020-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Novel Coronavirus Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MP group

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

Methylprednisolone 1mg/kg/day ivgtt for 7 days.

Con group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methylprednisolone

Methylprednisolone 1mg/kg/day ivgtt for 7 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shi Huanzhong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hubei province hospital of integrated Chinese & Western Medicine

Wuhan, Hubei, China

Site Status

Yichang first people's Hospital

Yichang, Hubei, China

Site Status

Beijing YouAn Hospital

Beijing, , China

Site Status

Renmin Hospital of Wuhan University

Wuhan, , China

Site Status

Tianyou Hospital Affiliated to Wuhan University of science and technology

Wuhan, , China

Site Status

Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology

Wuhan, , China

Site Status

the first peopel hospital of Xiangyang

Xiangyang, , China

Site Status

Countries

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China

References

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Tang X, Feng YM, Ni JX, Zhang JY, Liu LM, Hu K, Wu XZ, Zhang JX, Chen JW, Zhang JC, Su J, Li YL, Zhao Y, Xie J, Ding Z, He XL, Wang W, Jin RH, Shi HZ, Sun B. Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial. Respiration. 2021;100(2):116-126. doi: 10.1159/000512063. Epub 2021 Jan 22.

Reference Type DERIVED
PMID: 33486496 (View on PubMed)

Other Identifiers

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Methylprednisolone in COVID-19

Identifier Type: -

Identifier Source: org_study_id

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