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NCT Number: NCT04636671

Methylprednisolone vs. Dexamethasone in COVID-19 Pneumonia (MEDEAS RCT)

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).

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Viral Pneumonia Human Coronavirus Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Marco Confalonieri

Trieste, TS, 34149, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and sign the informed consent
  • SARS-CoV-2 positive on at least one upper respiratory swab or bronchoalveolar lavage
  • PaO2 <= 60 mmHg or SpO2 <= 90% or on oxygen therapy (any), CPAP or NPPV at randomization
  • Age >= 18 years old at randomization

Exclusion criteria

  • On invasive mechanical ventilation (either intubated or tracheostomized)
  • Heart failure as the main cause of acute respiratory failure
  • On long-term oxygen or home mechanical ventilation
  • Decompensated liver cirrhosis
  • Immunosuppression (i.e., cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)
  • On chronic steroid therapy or other immunomodulant therapy (e.g., azathioprine, methotrexate, mycophenolate, convalescent/hyperimmune plasma)
  • Chronic renal failure with dialysis dependence
  • Progressive neuro-muscular disorders
  • Cognitively impaired, dementia or decompensated psychiatric disorder
  • Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
  • Do-not-resuscitate order
  • Participating in other clinical trial including experimental compound with proved or expected activity against SARS-CoV-2 infection
  • Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with protocol intervention
  • Refuse to participate in the study or absence of signed informed consent form.

Treatment and study plan

methylprednisolone

Drug

Per-protocol methylprednisolone administration and tapering (see arm description)

Dexamethasone

Drug

Per-protocol dexamethasone administration (see arm description)

Primary outcomes

  1. Survival

    Time frame: 28 days

    Survival proportion at 28 days in both arms

Secondary outcomes

  1. Reduction in the need for mechanical ventilation

    Time frame: 28 days

    Number of days free from mechanical ventilation (either noninvasive or invasive) by study day 28 in both arms

  2. Length of hospitalization

    Time frame: From date of randomization until the date of hospital discharge, assessed up to 60 days

    Number of days of hospitalization for patients discharged alive in both arms

  3. Need for tracheostomy

    Time frame: Day 28

    Proportion of patients requiring tracheostomy in both arms

  4. Reduction in systemic inflammation markers

    Time frame: Day 3, 7 and 14

    C-reactive protein level (mg/L) at study day 3, 7 and 14 in both arms

  5. Amelioration of oxygenation

    Time frame: Day 3, 7 and 14

    PaO2/FiO2 ratio (mmHg) at study day 3, 7 and 14 in both arms

  6. Disease progression

    Time frame: Day 3, 7 and 14

    WHO clinical progression scale at study day 3, 7 and 14 in both arms

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Collaborators

  • Centro di Riferimento Oncologico - Aviano
  • National Institute for the Infectious Diseases (L. Spallanzani) - Rome

Registry information

Official study title

Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial)

Acronym: MEDEAS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2020
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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