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

Phase 2

Completed

• Conditions: SARS-CoV Infection; Severe Acute Respiratory Syndrome (SARS) Pneumonia
• Interventions: Drug: Methylprednisolone Sodium Succinate; Drug: Placebo solution

• Registration Number: NCT04343729
• Lead Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Study Start: 2020-04-18
• Primary Completion: 2020-06-16
• Study Completion: 2020-10-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone	Methylprednisolone Sodium Succinate	0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.
Placebo	Placebo solution	Saline solution, twice daily, for 5 days. Injectable.

Primary Outcome Measures

Name	Time	Method
Mortality rate at day 28	on day 28, after randomization	Mortality rate on day 28, after randomization

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz; 🇧🇷 Manaus, Amazonas, Brazil