Status:
COMPLETED
Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19
Lead Sponsor:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Conditions:
SARS-CoV Infection
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
- 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);
- SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation
Exclusion
- History of hypersensitivity to MPS;
- People living with HIV and AIDS;
- Chronic use of corticosteroids or immunosuppressive agents;
- Pregnancy or breastfeeding;
- Decompensated cirrhosis;
- Chronic renal failure.
Key Trial Info
Start Date :
April 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2020
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT04343729
Start Date
April 18 2020
End Date
October 20 2020
Last Update
July 28 2021
Active Locations (1)
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1
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Manaus, Amazonas, Brazil, 69093-415