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

Sponsor

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado (Other)

Overall Status

Completed

CT.gov ID

NCT04343729

Collaborator

(none)

416

Enrollment

Location

Arms

6.1

Actual Duration (Months)

68.4

Patients Per Site Per Month

Study Details

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).

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

Study Type:

Interventional

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 :

Apr 18, 2020

Actual Primary Completion Date :

Jun 16, 2020

Actual Study Completion Date :

Oct 20, 2020

Arms and Interventions

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 Names: methylprednisolone
Placebo Comparator: Placebo Saline solution, twice daily, for 5 days. Injectable.	Drug: Placebo solution injectable saline solution Other Names: placebo

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 Names:

methylprednisolone

Placebo Comparator: Placebo

Saline solution, twice daily, for 5 days. Injectable.

Drug: Placebo solution

injectable saline solution

Other Names:

placebo

Outcome Measures

Primary Outcome Measures

Mortality rate at day 28 [on day 28, after randomization]
Mortality rate on day 28, after randomization

Secondary Outcome Measures

Mortality rate on days 7, 14 and 28 [after randomization, up to 28 days.]
Proportion of patient that died on days 7, 14 and 28.
Incidence of orotracheal intubation [after randomization, up to 7 days.]
proportion of patients requiring orotracheal intubation
Change in oxygenation index [after randomization, up to 7 days.]
Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.

Other Outcome Measures

Spirometry (exploratory outcome) [120 days after randomization]
Forced expiratory capacity at the first second of exhalation (FEV1) in liters
Spirometry (exploratory outcome) [120 days after randomization]
Forced vital capacity (FVC) in liters
Spirometry (exploratory outcome) [120 days after randomization]
FEV1/FVC ratio
Spirometry (exploratory outcome) [120 days after randomization]
Forced expiratory flow (FEF) in cmH2O
Spirometry (exploratory outcome) [120 days after randomization]
Peak expiratory flow (PEF) in cmH2O

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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