Official Title
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.
Brief Summary

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).

Active, not recruiting
SARS-CoV Infection
Severe Acute Respiratory Syndrome (SARS) Pneumonia

Drug: Methylprednisolone Sodium Succinate
injectable solution at a dose of 0.5mg/kg
Methylprednisolone
Other Name: methylprednisolone

Drug: Placebo solution
injectable saline solution
Placebo
Other Name: placebo

Eligibility Criteria

Inclusion Criteria: 1. Suspected cases of COVID-19, from clinical and radiological data, during the pandemic; 2. 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); 3. SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation

Exclusion Criteria: 1. History of hypersensitivity to MPS; 2. People living with HIV and AIDS; 3. Chronic use of corticosteroids or immunosuppressive agents; 4. Pregnancy or breastfeeding; 5. Decompensated cirrhosis; 6. Chronic renal failure.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Brazil
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
NCT Number
Keywords
SARS-CoV-2
Covid-19
Corticosteroid
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Coronavirus
Methylprednisolone
MeSH Terms
Severe Acute Respiratory Syndrome
Coronavirus Infections
Pneumonia
Syndrome
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate