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
|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|
|Estimated Study Completion Date :||September 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.
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|