NCT04343729

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• SARS-CoV Infection
• Severe Acute Respiratory Syndrome (SARS) Pneumonia

Interventions

Type	Name	Description
DRUG	Methylprednisolone Sodium Succinate	injectable solution at a dose of 0.5mg/kg
DRUG	Placebo solution	injectable saline solution

Timeline

• Start date: 2020-04-18
• Primary completion: 2020-06-16
• Completion: 2020-10-20
• First posted: 2020-04-13
• Last updated: 2021-07-28

Locations

1 site across 1 country: Brazil