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NCT Number: NCT04343729

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

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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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Severe Acute Respiratory Syndrome (SARS) Pneumonia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Manaus, Amazonas, 69093-415, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
  • 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);
  • SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation

Exclusion criteria

  • History of hypersensitivity to MPS;
  • People living with HIV and AIDS;
  • Chronic use of corticosteroids or immunosuppressive agents;
  • Pregnancy or breastfeeding;
  • Decompensated cirrhosis;
  • Chronic renal failure.

Treatment and study plan

Methylprednisolone Sodium Succinate

Drug

injectable solution at a dose of 0.5mg/kg

Other names: methylprednisolone

Placebo solution

Drug

injectable saline solution

Other names: placebo

Primary outcomes

  1. Mortality rate at day 28

    Time frame: on day 28, after randomization

    Mortality rate on day 28, after randomization

Secondary outcomes

  1. 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.

  2. Incidence of orotracheal intubation

    Time frame: after randomization, up to 7 days.

    proportion of patients requiring orotracheal intubation

  3. Change in oxygenation index

    Time frame: after randomization, up to 7 days.

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

Other outcomes

  1. Spirometry (exploratory outcome)

    Time frame: 120 days after randomization

    Forced expiratory capacity at the first second of exhalation (FEV1) in liters

  2. Spirometry (exploratory outcome)

    Time frame: 120 days after randomization

    Forced vital capacity (FVC) in liters

  3. Spirometry (exploratory outcome)

    Time frame: 120 days after randomization

    FEV1/FVC ratio

  4. Spirometry (exploratory outcome)

    Time frame: 120 days after randomization

    Forced expiratory flow (FEF) in cmH2O

  5. Spirometry (exploratory outcome)

    Time frame: 120 days after randomization

    Peak expiratory flow (PEF) in cmH2O

Sponsors and collaborators

Lead sponsor

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Other

Registry information

Official study title

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.

Acronym: MetCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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