A clinical trial for patients with Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial)

The University of Trieste is commencing recruitment for the clinical trial of the Methylprednisolone vs. Dexamethasone in COVID-19 Pneumonia (MEDEAS RCT).

The conditions are Covid19, Viral Pneumonia Human Coronavirus, Severe Acute Respiratory Syndrome.

The trial officially began on the November 25, 2020 and is planned to complete on April 30, 2021.

Low-dose glucocorticoid treatment is the only intervention shown to significantly reduce mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support. In particular, a large UK randomized controlled trial (RECOVERY trial) demonstrated the efficacy of dexamethasone at a dosage of 6mg/day for 10 days in reducing mortality compared to usual therapy, with a greater impact on patients requiring mechanical ventilation (36% reduction) or oxygen therapy (18% reduction) than on those who did not need respiratory support (doi: 10.1056/NEJMoa2021436). However, there is still paucity of information guiding glucocorticoid administration in severe pneumonia/ARDS and no evidence of the superiority of a steroid drug -nor of a therapeutic scheme- compared to the others, which led to a great heterogeneity of treatment protocols and misinterpretation of available findings. In a recent longitudinal observational study conducted in Italian respiratory high-dependency units, a protocol with prolonged low-dose methylprednisolone demonstrated a 71% reduction in mortality and the achievement of other secondary endpoints such as an increase in ventilation-free days by study day 28 in a subgroup of patients with severe pneumonia and high levels of systemic inflammation (doi: 10.1093/ofid/ofaa421). The treatment was well tolerated and did not affect viral shedding from the airways. In light of these data, the present study aims to compare the efficacy of a methylprednisolone protocol and that of a dexamethasone protocol based on previous evidence in increasing survival by day 28, as well as in reducing the need and duration for mechanical ventilation, among hospitalized patients requiring noninvasive respiratory support (oxygen supplementation and/or noninvasive ventilation).

Inclusion Criteria: 1. Able to understand and sign the informed consent 2. SARS-CoV-2 positive on at least one upper respiratory swab or bronchoalveolar lavage 3. PaO2 <= 60 mmHg or SpO2 <= 90% or on HFNC, CPAP or NPPV at randomization 4. Age >= 18 years old at randomization

The following population cannot be included into the study: 1. On invasive mechanical ventilation (either intubated or tracheostomized) 2. Heart failure as the main cause of acute respiratory failure 3. On long-term oxygen or home mechanical ventilation 4. Decompensated liver cirrhosis 5. Immunosuppression (i.e., cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy) 6. Chronic renal failure with dialysis dependence 7. Progressive neuro-muscular disorders 8. Cognitively impaired, dementia or decompensated psychiatric disorder 9. Quadriplegia/Hemiplegia or quadriparesis/hemiparesis 10. Do-not-resuscitate order 11. Previous or current use of Remdesivir 12. Participating in other clinical trial including experimental compound with proved or expected activity against SARS-CoV-2 infection 13. Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with protocol intervention

Centro di Riferimento Oncologico - Aviano, National Institute for the Infectious Diseases (L. Spallanzani) - Rome are the collaborators in this clinical trial.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04636671

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