Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia

• Status: Withdrawn
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The COVID-19 pandemic has been spreading continuously, and in Brazil, until July 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. The present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with COVID-19 pneumonia in a randomized, controlled, 2x2 factorial study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: D'Or Institute for Research and Education
• Treatments: Heparin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Confirmed diagnosis of COVID-19 by RT-PCR or serology with presence of IgM positive antibodies;

• Lung image (X-ray or chest CT) with involvement of at least 25% of the parenchyma;

• O2 saturation in ambient air less than or equal to 93%

• Alteration of inflammatory tests

• D-Dimer above the reference value and

• Elevation of C-reactive protein, ferritin or lactic dehydrogenase

• Sign the consent form.

Exclusion Criteria:

• QT interval prolongation

• Imminence of orotracheal intubation (intubation prediction in the first 4 hours after randomization)

• Women who are pregnant or breastfeeding

• Corticosteroid allergy or intolerance

• Chronic corticosteroid users (prednisone equivalent > 10 mg daily)

• Patients diagnosed with cancer with increased bleeding potential

• Patients in hemodialysis

• History of peptic ulcer

• Herpes zoster infection

• History or active treatment of tuberculosis

• Systemic fungal infection

• Use of anticoagulation due to previous pathology

• Glaucoma

• Live virus vaccine up to 90 days before randomization

• Known coagulopathy or thrombocytopenia (<40,000/mm3) or hypofibrinogenemia (< 50 mg/dL)

• Recent bleeding

• Another limiting comorbidity for administering the therapies provided for in this protocol in in researcher's opinion