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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2022-05-04

Brief Summary

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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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Detailed Description

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Conditions

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Covid19 Viral Pneumonia Human Coronavirus Severe Acute Respiratory Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methylprednisolone

A. On day 1, loading dose of methylprednisolone (MP) 80 mg IV in 30 minutes, promptly followed by continuous infusion of MP 80 mg/day in 240 mL of normal saline at 10 mL/h.

B. From day 2 to day 8: infusion of MP 80 mg/day in 240 mL of normal saline at 10 mL/h.

C. From day 9 and beyond:

1. If not intubated patient and PaO2/FiO2 \> 200, taper to MP 20 mg IV in 30 minutes three times a day for 3 days, then MP 20 mg IV twice daily for 3 days, then MP 20 mg IV once daily for 2 days, then switch to MP 16 mg/day PO for 2 days, then MP 8mg/day PO for 2 days, then MP 4mg/day PO for 2 days;
2. If intubated patient or PaO2/FiO2 \<= 200 with at least 5 cmH2O CPAP, continue infusion of MP 80 mg/day in 240 mL of normal saline at 10 mL/h until PaO2/FiO2 \> 200 then taper as in a)

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

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

Dexamethasone

A. Dexamethasone (DM) 6 mg IV in 30 minutes or PO from day 1 to day 10 or until hospital discharge (if sooner).

B. After day 10 study treatment is interrupted.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Per-protocol dexamethasone administration (see arm description)

Interventions

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Methylprednisolone

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

Intervention Type DRUG

Dexamethasone

Per-protocol dexamethasone administration (see arm description)

Intervention Type DRUG

Eligibility Criteria

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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 oxygen therapy (any), CPAP or NPPV at randomization
4. Age \>= 18 years old at randomization

Exclusion Criteria

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. On chronic steroid therapy or other immunomodulant therapy (e.g., azathioprine, methotrexate, mycophenolate, convalescent/hyperimmune plasma)
7. Chronic renal failure with dialysis dependence
8. Progressive neuro-muscular disorders
9. Cognitively impaired, dementia or decompensated psychiatric disorder
10. Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
11. Do-not-resuscitate order
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
14. Refuse to participate in the study or absence of signed informed consent form.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No