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

COVID-19 Clinical Trial

Official title:

Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04485429
• Other study ID #: 31180820600005249
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 20, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• Methylprednisolone
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.
• Heparin
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.

Locations

Country	Name	City	State
Brazil	D'Or Institute for Research and Education	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of invasive mechanical ventilation		28 days
Secondary	Severity assessment by ordinal severity scale	Severity assessment will be performed using the ordinal severity scale during hospitalization.	3 days, 7 days, 14 days, 28 days after randomization
Secondary	Severity assessment by SOFA score	Severity assessment will be performed using the SOFA score during hospitalization.	3 days, 7 days, 14 days, 28 days after randomization
Secondary	Length of hospital stay		28 days
Secondary	Length of stay in intensive care		28 days
Secondary	Death rate		14 days, 28 days, 60 days, 90 days after randomization