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Glucocorticoid Therapy for Novel CoronavirusCritically Ill Patients With Severe Acute Respiratory Failure (Steroids-SARI)

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ClinicalTrials.gov Identifier: NCT04244591
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Zhongda Hospital
Zhongnan Hospital
Renmin Hospital of Wuhan University
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for 2019 novel coronavirus (2019-nCoV) patents with Severe acute respiratory failure.

Condition or disease Intervention/treatment Phase
Coronavirus Infections Respiratory Infection Virus Drug: methylprednisolone therapy Other: Standard care Phase 2 Phase 3

Detailed Description:

2019 novel coronavirus (2019-nCoV) is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with novel coronavirus (SARI-nCoV) 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 2019-nConV remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with SARI-nCoV.

In this study, critically ill patients with 2019-nConV 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by Noval Coronovirus 2019-nCoV: a Prospective, Randomized Controlled Trial
Actual Study Start Date : January 26, 2020
Estimated Primary Completion Date : April 25, 2020
Estimated Study Completion Date : December 25, 2020


Arm Intervention/treatment
Placebo Comparator: standard care
standard care
Other: Standard care
Standard care

Experimental: standard care + methylprednisolone therapy
Methylprednisolone 40 mg q12h for 5 days
Drug: methylprednisolone therapy
Methylprednisolone 40 mg q12h for 5 days
Other Name: Steroids




Primary Outcome Measures :
  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 16 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 16 according to the severity of the condition.


Secondary Outcome Measures :
  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



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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:

  • Adult
  • PCR confirmed noval coronavirus 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

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): NCT04244591


Locations
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China, Beijing
Medical ICU,Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 010
Contact: Bin Du, MD    8610-6915-5036    dubin98@gmail.com   
Contact: Li Weng, MD    8610-6915-4035    wengli@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Zhongda Hospital
Zhongnan Hospital
Renmin Hospital of Wuhan University

Publications:
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04244591    
Other Study ID Numbers: Glucocorticoid nCoV
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Infection
Communicable Diseases
Respiratory Tract Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents