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

Overview

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).

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 16, 2020

Interventions

  • Drug: Methylprednisolone Sodium Succinate
    • injectable solution at a dose of 0.5mg/kg
  • Drug: Placebo solution
    • injectable saline solution

Arms, Groups and Cohorts

  • Active Comparator: Methylprednisolone
    • 0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.
  • Placebo Comparator: Placebo
    • Saline solution, twice daily, for 5 days. Injectable.

Clinical Trial Outcome Measures

Primary Measures

  • Mortality rate at day 28
    • Time Frame: on day 28, after randomization
    • Mortality rate on day 28, after randomization

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
  • Provider of Information About this Clinical Study
    • Sponsor

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