Randomized controlled trial to evaluate the efficacy of per-protocol administration of Methylprednisolone compared to Dexamethasone in SARS-CoV-2 infections requiring respiratory support.

Phase 1

• Conditions: Hospitalized patients with COVID-19 requiring respiratory support; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-006054-43-IT
• Lead Sponsor: niversità degli Studi di Trieste

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-22
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

a)Able to understand and sign the informed consent form
b)SARS-CoV-2 positive on at least one upper respiratory swab or bronchoalveolar lavage
c)PaO2 <= 60 mmHg or SpO2 <= 90% or on HFNC, CPAP or NPPV at randomization
d)Age >= 18 years old at randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of the methylprednisolone protocol in improving survival by day 28 compared to the dexamethasone protocol.;Secondary Objective: To compare efficacy of the two protocols in achieving:<br>a)Reduction in the need and duration of mechanical ventilation<br>b)Reduction in hospital mortality<br>c)Reduction in the duration of hospitalization<br>d)Reduction in duration of requirement for oxygen supplementation<br>e) Reduction in C-reactive protein levels<br>f) Reduction in disease progression as assessed by WHO clinical progression scale;Primary end point(s): Survival proportion at 28 days in both arms;Timepoint(s) of evaluation of this end point: 28 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) Number of days free from mechanical ventilation (either NPPV or IMV) by study day 28 in both arms<br>b)Number of days of hospitalization among survivors in both arms<br>c)Proportion of patients requiring tracheostomy in both arms<br>d)C-reactive protein level (mg/L) at study day 3, 7 and 14 in both arms<br>e)PaO2/FiO2 ratio (mmHg) at study day 3, 7 and 14 in both arms<br>f)WHO clinical progression scale at study day 3, 7 and 14 in both arms;Timepoint(s) of evaluation of this end point: 3, 7, 14, 28 days