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

SARS-CoV Infection Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343729
• Other study ID #: CAEE: 30615920.2.0000.0005
• Status: Completed
• Phase: Phase 2
• Start date: April 18, 2020
• Est. completion date: October 20, 2020

Study information

• Verified date: July 2021
• Source: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: October 20, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome (SARS) Pneumonia
• Syndrome

Intervention

Drug:
• Methylprednisolone Sodium Succinate
injectable solution at a dose of 0.5mg/kg
• Placebo solution
injectable saline solution

Locations

Country	Name	City	State
Brazil	Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz	Manaus	Amazonas

Sponsors (1)

Lead Sponsor	Collaborator
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spirometry (exploratory outcome)	Forced expiratory capacity at the first second of exhalation (FEV1) in liters	120 days after randomization
Other	Spirometry (exploratory outcome)	Forced vital capacity (FVC) in liters	120 days after randomization
Other	Spirometry (exploratory outcome)	FEV1/FVC ratio	120 days after randomization
Other	Spirometry (exploratory outcome)	Forced expiratory flow (FEF) in cmH2O	120 days after randomization
Other	Spirometry (exploratory outcome)	Peak expiratory flow (PEF) in cmH2O	120 days after randomization
Primary	Mortality rate at day 28	Mortality rate on day 28, after randomization	on day 28, after randomization
Secondary	Mortality rate on days 7, 14 and 28	Proportion of patient that died on days 7, 14 and 28.	after randomization, up to 28 days.
Secondary	Incidence of orotracheal intubation	proportion of patients requiring orotracheal intubation	after randomization, up to 7 days.
Secondary	Change in oxygenation index	Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.	after randomization, up to 7 days.