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

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Status and phase: Completed; Phase 2

Conditions: Severe Acute Respiratory Syndrome (SARS) Pneumonia; SARS-CoV Infection

Treatments: Drug: Placebo solution; Drug: Methylprednisolone Sodium Succinate

Study type: Interventional

Funder types: Other

Identifiers

NCT04343729

CAEE: 30615920.2.0000.0005

Details and patient eligibility

About

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).

Enrollment: 416 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.

Treatment:

Drug: Methylprednisolone Sodium Succinate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo solution