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NCT Number: NCT04244591

Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure

In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medical ICU,Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

About this study

COVID-19 is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with COVID-19 causes severe acute respiratory failure with substantial mortality. Currently, the standard care is supportive care, and no treatment is proven to be effective for this condition.

Glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). However, whether glucocorticoid improved the outcome of COVID-19 remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with COVID-19.

In this study, critically ill patients with COVID-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. The primary outcome is the difference of Murray lung injury score between two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult
  • PCR confirmed COVID-19 infection
  • Symptoms developed more than 7 days
  • PaO2/FiO2 < 200 mmHg
  • Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours
  • Requiring ICU admission

Exclusion criteria

  • pregnancy;
  • patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent);
  • Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease;
  • Severe adverse events before ICU admission, i.e. cardiac arrest;
  • Underlying disease requiring corticosteroids;
  • Contraindication for corticosteroids;
  • Recruited in other clinical intervention trial

Treatment and study plan

methylprednisolone therapy

Drug

Methylprednisolone 40 mg q12h for 5 days

Other names: Steroids

Standard care

Other

Standard care

Primary outcomes

  1. Lower Murray lung injury score

    Time frame: 7 days after randomization

    Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

  2. Lower Murray lung injury score

    Time frame: 14 days after randomization

    Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

Secondary outcomes

  1. The difference of PaO2/FiO2 between two groups

    Time frame: 7 days after randomization

    PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

  2. Lower Sequential Organ Failure Assessment (SOFA) score

    Time frame: 7 days after randomization

    Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

  3. Mechanical ventilation support

    Time frame: 7 days after randomization

    Percentage of patients requiring Mechanical ventilation support

  4. The difference of PaO2/FiO2 between two groups

    Time frame: 14 days after randomization

    PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

  5. Lower Sequential Organ Failure Assessment (SOFA) score

    Time frame: 14 days after randomization

    Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

  6. Mechanical ventilation support

    Time frame: 14 days after randomization

    Percentage of patients requiring Mechanical ventilation support

  7. Clearance of noval coronavirus

    Time frame: 14 days after randomization

    Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract

  8. All-cause mortality

    Time frame: 30 days after randomization

    All-cause mortality

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Renmin Hospital of Wuhan University
  • Zhongda Hospital
  • Zhongnan Hospital

Registry information

Official study title

Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Jun 16, 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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