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

Phase 3

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Heparin; Drug: Methylprednisolone

• Registration Number: NCT04485429
• Lead Sponsor: D'Or Institute for Research and Education

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Full-dose heparin + Standard treatment	Heparin	Participants will receive the standard treatment and full-dose heparin,
Methylprednisolone + Full-dose heparin + Standard treatment	Heparin	Participants will receive the standard treatment, methylprednisolone and full-dose heparin
Methylprednisolone + Standard treatment	Methylprednisolone	Participants will receive the standard treatment and methylprednisolone.
Methylprednisolone + Full-dose heparin + Standard treatment	Methylprednisolone	Participants will receive the standard treatment, methylprednisolone and full-dose heparin

Primary Outcome Measures

Name	Time	Method
Rate of invasive mechanical ventilation	28 days

Secondary Outcome Measures

Name	Time	Method
Severity assessment by ordinal severity scale	3 days, 7 days, 14 days, 28 days after randomization	Severity assessment will be performed using the ordinal severity scale during hospitalization.
Severity assessment by SOFA score	3 days, 7 days, 14 days, 28 days after randomization	Severity assessment will be performed using the SOFA score during hospitalization.
Length of hospital stay	28 days
Length of stay in intensive care	28 days
Death rate	14 days, 28 days, 60 days, 90 days after randomization

Trial Locations

Locations (1)

D'Or Institute for Research and Education; 🇧🇷 Rio de Janeiro, Brazil