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

  • STATUS
    Recruiting
  • participants needed
    268
  • sponsor
    D'Or Institute for Research and Education
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Updated on 5 August 2020
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x-rays
heparin
pneumonia
oximetry
d-dimer
methylprednisolone
covid-19
chest ct
o2 saturation

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.

Details
Condition Covid 19
Age 18years - 100years
Treatment Methylprednisolone, Heparin
Clinical Study IdentifierNCT04485429
SponsorD'Or Institute for Research and Education
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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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
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