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

D'Or Institute for Research and Education

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

COVID-19

Interventions

MethylprednisoloneDRUG

Methylprednisolone 0.5 mg/kg every 12 hours intravenously for the first 14 days; followed by 0.5 mg/kg/day from day 15 to day 21; followed by 0.25mg/kg/day from day 22 to day 25; followed by 0.125 mg/kg/day, from day 26 to day 28 of treatment.

HeparinDRUG

Enoxaparin 1 mg/kg subcutaneously every 12 hours (if creatinine clearance greater than 40ml/min) or Unfractionated heparin dosed to target activated partial thromboplastin time (aPTT) between 1.5 - 2.0 times the normal value (if creatinine clearance less or equal to 40ml/min). The treatment period with full-dose heparin will be 7 days. After 7 days of full-dose heparin, patients will continue using prophylactic dose of heparin, according to the standard treatment routine.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

D'Or Institute for Research and Education

Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Rate of invasive mechanical ventilation

Time frame: 28 days

Secondary Outcomes

Severity assessment by ordinal severity scale

Severity assessment will be performed using the ordinal severity scale during hospitalization.

Time frame: 3 days, 7 days, 14 days, 28 days after randomization

Severity assessment by SOFA score

Severity assessment will be performed using the SOFA score during hospitalization.

Time frame: 3 days, 7 days, 14 days, 28 days after randomization

Length of hospital stay

Time frame: 28 days

Length of stay in intensive care

Time frame: 28 days

Death rate

Time frame: 14 days, 28 days, 60 days, 90 days after randomization

Data from ClinicalTrials.gov

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