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

• Status: Completed
• Trial end date: 2020-10-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Pharmaceutical Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.