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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 : Active, not recruiting
First Posted : April 13, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

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

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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
Estimated Study Completion Date : September 2020


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




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.



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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.

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
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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 1, 2020
Last Verified: June 2020
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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Severe Acute Respiratory Syndrome
Coronavirus Infections
Pneumonia
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract 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
Neuroprotective Agents