Back to resultsMethylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19 (MetCOVID)
Primary Purpose
SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Methylprednisolone Sodium Succinate
Placebo solution
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV Infection focused on measuring SARS-CoV-2, Covid-19, Corticosteroid, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Coronavirus, methylprednisolone
Eligibility Criteria
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.
Sites / Locations
- Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Methylprednisolone
Placebo
Arm Description
0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.
Saline solution, twice daily, for 5 days. Injectable.
Outcomes
Primary Outcome Measures
Mortality rate at day 28
Mortality rate on day 28, after randomization
Secondary Outcome Measures
Mortality rate on days 7, 14 and 28
Proportion of patient that died on days 7, 14 and 28.
Incidence of orotracheal intubation
proportion of patients requiring orotracheal intubation
Change in oxygenation index
Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.
Full Information
NCT ID
NCT04343729
First Posted
April 9, 2020
Last Updated
July 21, 2021
Sponsor
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
1. Study Identification
Unique Protocol Identification Number
NCT04343729
Brief Title
Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19
Acronym
MetCOVID
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 18, 2020 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia
Keywords
SARS-CoV-2, Covid-19, Corticosteroid, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Coronavirus, methylprednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline solution, twice daily, for 5 days. Injectable.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Sodium Succinate
Other Intervention Name(s)
methylprednisolone
Intervention Description
injectable solution at a dose of 0.5mg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo solution
Other Intervention Name(s)
placebo
Intervention Description
injectable saline solution
Primary Outcome Measure Information:
Title
Mortality rate at day 28
Description
Mortality rate on day 28, after randomization
Time Frame
on day 28, after randomization
Secondary Outcome Measure Information:
Title
Mortality rate on days 7, 14 and 28
Description
Proportion of patient that died on days 7, 14 and 28.
Time Frame
after randomization, up to 28 days.
Title
Incidence of orotracheal intubation
Description
proportion of patients requiring orotracheal intubation
Time Frame
after randomization, up to 7 days.
Title
Change in oxygenation index
Description
Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.
Time Frame
after randomization, up to 7 days.
Other Pre-specified Outcome Measures:
Title
Spirometry (exploratory outcome)
Description
Forced expiratory capacity at the first second of exhalation (FEV1) in liters
Time Frame
120 days after randomization
Title
Spirometry (exploratory outcome)
Description
Forced vital capacity (FVC) in liters
Time Frame
120 days after randomization
Title
Spirometry (exploratory outcome)
Description
FEV1/FVC ratio
Time Frame
120 days after randomization
Title
Spirometry (exploratory outcome)
Description
Forced expiratory flow (FEF) in cmH2O
Time Frame
120 days after randomization
Title
Spirometry (exploratory outcome)
Description
Peak expiratory flow (PEF) in cmH2O
Time Frame
120 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
City
Manaus
State/Province
Amazonas
ZIP/Postal Code
69093-415
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all patient data will be shared after study publication
IPD Sharing Time Frame
after study publication.
IPD Sharing Access Criteria
upon formal request.
Citations:
PubMed Identifier
34917633
Citation
Barros CMSS, Freire RS, Frota E, Rezende Santos AG, Farias MEL, Rodrigues MGA, Silva BM, Prado Jeronimo CM, Netto RLA, Silva Borba MG, Baia-da-Silva D, Brito-Sousa JD, Xavier MS, Araujo-Alexandre MA, Sampaio VS, Melo GC, Areas GT, Hajjar LA, Monteiro WM, Gomes Naveca F, Costa FTM, Val FFA, Lacerda MVG; Metcovid team. Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial. Front Med (Lausanne). 2021 Nov 30;8:758405. doi: 10.3389/fmed.2021.758405. eCollection 2021.
Results Reference
derived
PubMed Identifier
32785710
Citation
Jeronimo CMP, Farias MEL, Val FFA, Sampaio VS, Alexandre MAA, Melo GC, Safe IP, Borba MGS, Netto RLA, Maciel ABS, Neto JRS, Oliveira LB, Figueiredo EFG, Oliveira Dinelly KM, de Almeida Rodrigues MG, Brito M, Mourao MPG, Pivoto Joao GA, Hajjar LA, Bassat Q, Romero GAS, Naveca FG, Vasconcelos HL, de Araujo Tavares M, Brito-Sousa JD, Costa FTM, Nogueira ML, Baia-da-Silva DC, Xavier MS, Monteiro WM, Lacerda MVG; Metcovid Team. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial. Clin Infect Dis. 2021 May 4;72(9):e373-e381. doi: 10.1093/cid/ciaa1177.
Results Reference
derived
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Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19
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