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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04343729

Acronym

MetCOVID

Enrollment

416

Registered

2020-04-13

Start date

2020-04-18

Completion date

2020-10-20

Last updated

2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

SARS-CoV-2, Covid-19, Corticosteroid, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Coronavirus, methylprednisolone

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).

Interventions

DRUGMethylprednisolone Sodium Succinate

injectable solution at a dose of 0.5mg/kg

DRUGPlacebo solution

injectable saline solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Mortality rate at day 28	on day 28, after randomization	Mortality rate on day 28, after randomization

Secondary

Measure	Time frame	Description
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

Measure	Time frame	Description
Spirometry (exploratory outcome)	120 days after randomization	Forced expiratory capacity at the first second of exhalation (FEV1) in liters

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026