Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome

• Status: Completed
• Trial end date: 2020-05-10
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Trieste
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. SARS-CoV-2 positive

2. Age >17 years and < 80 years

3. P/F < 250 mmHg

4. Bilateral pneumonia (infiltrates/interstitial)

5. CRP >10mg/dL (or >100mg/L)

6. 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