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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343729
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Drug: Methylprednisolone Sodium Succinate Drug: Placebo solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : April 18, 2020
Actual Primary Completion Date : June 16, 2020
Actual Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Methylprednisolone
0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.
 Drug: Methylprednisolone Sodium Succinate
injectable solution at a dose of 0.5mg/kg
Other Name: methylprednisolone
Placebo Comparator: Placebo
Saline solution, twice daily, for 5 days. Injectable.
 Drug: Placebo solution
injectable saline solution
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Mortality rate at day 28 [ Time Frame: on day 28, after randomization ]
    Mortality rate on day 28, after randomization


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343729


Locations
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Brazil
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Manaus, Amazonas, Brazil, 69093-415
Sponsors and Collaborators
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
ClinicalTrials.gov Identifier: NCT04343729    
Other Study ID Numbers: CAEE: 30615920.2.0000.0005
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all patient data will be shared after study publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: after study publication.
Access Criteria: upon formal request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado:
SARS-CoV-2
Covid-19
Corticosteroid
 Severe Acute Respiratory Syndrome (SARS) Pneumonia
Coronavirus
methylprednisolone
Additional relevant MeSH terms:
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Pneumonia
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Methylprednisolone
 Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists