N/A
N=173
Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
Severe Acute Respiratory Syndrome (SARS) Pneumonia · Coronavirus Infections · ARDS, Human
Bottom Line
View on ClinicalTrials.gov: NCT04323592 ↗Enrolled (actual)
173
Serious AEs
8.7%
Results posted
Jun 2020
Primary outcome: Primary: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 — 19; 40 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Methylprednisolone (Drug); standard care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Trieste
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 |
19; 40 | — |
| PRIMARY In-hospital Death Within 28 Days |
6; 21 | — |
| PRIMARY Admission to Intensive Care Unit (ICU) |
15; 27 | — |
| PRIMARY Endotracheal Intubation (Invasive Mechanical Ventilation) |
15; 26 | — |
| SECONDARY Change in C-reactive Protein (CRP) |
-82.08; -34.34 | — |
| SECONDARY Number of Days Free From Mechanical Ventilation |
19.11; 14.34 | — |
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 Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg.
The main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).
Eligibility Criteria
Inclusion Criteria
- SARS-CoV-2 positive
- Age >17 years and 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04323592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.