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

NCT04343729 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2021-07-28

No results posted yet for this study

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

DRUG

Methylprednisolone Sodium Succinate

injectable solution at a dose of 0.5mg/kg

DRUG

Placebo solution

injectable saline solution

Sponsors & Collaborators

  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-18
Primary Completion
2020-06-16
Completion
2020-10-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04343729 on ClinicalTrials.gov