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Efficacy of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome

2020-04-01 04:26:51 | BioPortfolio

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. We're routinely using MP for severe pneumonia-ARDS with acute respiratory failure with very good results.

The main objective of this multi-centre observational trial is to evaluate the efficacy of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome.

Description

Comparison of two groups of patients SARS-CoV-2 positive with severe acute respiratory syndrome:

1. Consecutively treated with low prolonged doses of methylprednisolone

2. Historical patients never treated with corticosteroids

The two group will be matched (1:1) according to the following criteria:

1. sex

2. age <10 years difference

3. CRP level at admission (difference <20%)

4. SOFA score (difference <20%)

5. P/F difference <20%

Anti-viral agents, chloroquine, respiratory support (any), and antibiotics (any) will be permitted to each study group.

Corticosteroids use, other than methylprednisolone for MP-treated group is a reason of drop-out.

1. Methylprednisolone treated-group will receive at study entry Methylprednisolone 80mg iv bolus followed by Methylprednisolone 80mg in 240cc 0.9% saline iv infusion at 10cc/h for at least 8 days or more until PCR<20mg/L and/or P/F>350. Then methylprednisolone 16mg BID os slowly tapering until PCR normal range +/- normal range and P/F>400.

Group 1 will be treated also with usual respiratory support (oxygen, O2 high-flow nasal cannula, CPAP, noninvasive ventilation, invasive mechanical ventilation, ECMO).

2. Control group will be selected and matched among historical patients with the same disease and treatment, but without any administration of methylprednisolone and other corticosteroids.

Matching criteria will be the following (all of them):

1. same sex

2. age +/- 10 years

3. C-reactive protein within 20% value difference

4. P/F within 20% value difference

5. SOFA score within 20% value difference

Study Design

Conditions

Severe Acute Respiratory Syndrome (SARS) Pneumonia

Intervention

Methylprednisolone, standard care

Location

Marco Confalonieri
Trieste
TS
Italy
34149

Status

Recruiting

Source

University of Trieste

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-04-01T04:26:51-0400

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