Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19 (MetCOVID)
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|ClinicalTrials.gov Identifier: NCT04343729|
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : July 28, 2021
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||416 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Mortality rate at day 28 [ Time Frame: on day 28, after randomization ]Mortality rate on day 28, after randomization
- 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.
- Incidence of orotracheal intubation [ Time Frame: after randomization, up to 7 days. ]proportion of patients requiring orotracheal intubation
- Change in oxygenation index [ Time Frame: after randomization, up to 7 days. ]Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.
- Spirometry (exploratory outcome) [ Time Frame: 120 days after randomization ]Forced expiratory capacity at the first second of exhalation (FEV1) in liters
- Spirometry (exploratory outcome) [ Time Frame: 120 days after randomization ]Forced vital capacity (FVC) in liters
- Spirometry (exploratory outcome) [ Time Frame: 120 days after randomization ]FEV1/FVC ratio
- Spirometry (exploratory outcome) [ Time Frame: 120 days after randomization ]Forced expiratory flow (FEF) in cmH2O
- Spirometry (exploratory outcome) [ Time Frame: 120 days after randomization ]Peak expiratory flow (PEF) in cmH2O
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
|Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz|
|Manaus, Amazonas, Brazil, 69093-415|