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Completed

NCT Number: NCT04273321

Efficacy and Safety of Corticosteroids in COVID-19

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hubei province hospital of integrated Chinese & Western Medicine, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2020
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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