Methylprednisolone vs. Dexamethasone in COVID-19 Pneumonia (MEDEAS RCT)
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 3
Details
Lead Sponsor:
University of Trieste
Collaborators:
Centro di Riferimento Oncologico - Aviano National Institute for the Infectious Diseases (L. Spallanzani) - Rome