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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-18

Study Completion Date

2020-10-20

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylprednisolone

0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.

Group Type ACTIVE_COMPARATOR

Methylprednisolone Sodium Succinate

Intervention Type DRUG

injectable solution at a dose of 0.5mg/kg

Placebo

Saline solution, twice daily, for 5 days. Injectable.

Group Type PLACEBO_COMPARATOR

Placebo solution

Intervention Type DRUG

injectable saline solution

Interventions

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Methylprednisolone Sodium Succinate

injectable solution at a dose of 0.5mg/kg

Intervention Type DRUG

Placebo solution

injectable saline solution

Intervention Type DRUG

Other Intervention Names

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methylprednisolone placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No