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

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado416 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

416

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mortality rate at day 28

Mortality rate on day 28, after randomization

Time frame: on day 28, after randomization

Secondary Outcomes

Mortality rate on days 7, 14 and 28

Proportion of patient that died on days 7, 14 and 28.

Time frame: after randomization, up to 28 days.

Incidence of orotracheal intubation

proportion of patients requiring orotracheal intubation

Time frame: after randomization, up to 7 days.

Change in oxygenation index

Proportion of patients with oxygenation index (PaO2 / FiO2) \< 100 in 7 days.