Status:
COMPLETED
Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
Lead Sponsor:
University of Trieste
Conditions:
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Coronavirus Infections
Eligibility:
All Genders
18-80 years
Brief Summary
COVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day. A recent retrospective Chinese paper (JAMA I...
Detailed Description
Comparison of two groups of patients SARS-CoV-2 positive with severe acute respiratory syndrome: 1. Exposed to low prolonged doses of Methylprednisolone 2. Not exposed to corticosteroids (standard of...
Eligibility Criteria
Inclusion
- SARS-CoV-2 positive
- Age \>17 years and \< 80 years
- P/F \< 250 mmHg
- Bilateral pneumonia (infiltrates/interstitial)
- CRP \>10mg/dL (or \>100mg/L)
- Alternatively to 4-5-6 criteria a diagnosis of ARDS according to the Berlin definition (Ranieri M, et al. JAMA 2012)
Exclusion
- Heart failure as predominant cause of acute respiratory failure
- Decompensated liver cirrhosis
- Cancer
- Organ transplantation
- HIV+
- dialysis
- long-term oxygen therapy, home mechanical ventilation
- Idiopathic pulmonary fibrosis
- Progressive neuromuscular disorders (e.g. Duchenne, Pompe, ALS)
- Dementia or decompensated psychiatric diseases
- immunosuppressive treatments
- Chronic use of corticosteroids
- Use of Tocilizumab
- pregnancy
Key Trial Info
Start Date :
March 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2020
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT04323592
Start Date
March 23 2020
End Date
May 10 2020
Last Update
June 24 2020
Active Locations (1)
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1
Marco Confalonieri
Trieste, TS, Italy, 34149