Status:
WITHDRAWN
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia
Lead Sponsor:
D'Or Institute for Research and Education
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04485429
Start Date
July 20 2020
End Date
December 31 2022
Last Update
August 11 2021
Active Locations (1)
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1
D'Or Institute for Research and Education
Rio de Janeiro, Brazil