Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19

Study Overview
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Brief Summary
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This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).

Official Title
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Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial.

Conditions
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SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia

Intervention / Treatment
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* Drug: Methylprednisolone Sodium Succinate
* Drug: Placebo solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected cases of COVID-19, from clinical and radiological data, during the pandemic; Adult aged 18 years or older, at the time of inclusion (children under 18 will not be included due to the recognized lower lethality in previous published studies, and the difficulty of consent in the context of an emergency in public health); SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation Exclusion Criteria: History of hypersensitivity to MPS; People living with HIV and AIDS; Chronic use of corticosteroids or immunosuppressive agents; Pregnancy or breastfeeding; Decompensated cirrhosis; Chronic renal failure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone<br>0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days. | Drug: Methylprednisolone Sodium Succinate<br>* injectable solution at a dose of 0.5mg/kg<br>* Other names: methylprednisolone;|
| Placebo Comparator: Placebo<br>Saline solution, twice daily, for 5 days. Injectable. | Drug: Placebo solution<br>* injectable saline solution<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate at day 28 | Mortality rate on day 28, after randomization | on day 28, after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate on days 7, 14 and 28 | Proportion of patient that died on days 7, 14 and 28. | after randomization, up to 28 days. | 
| Incidence of orotracheal intubation | proportion of patients requiring orotracheal intubation | after randomization, up to 7 days. | 
| Change in oxygenation index | Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days. | after randomization, up to 7 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Covid-19, Corticosteroid, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Coronavirus, methylprednisolone