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

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Methylprednisolone
Heparin
Sponsored by
D'Or Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Heparin, Methylprednisolone, Anticoagulation, Coagulopathy, Respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • D'Or Institute for Research and Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Methylprednisolone + Standard treatment

Full-dose heparin + Standard treatment

Methylprednisolone + Full-dose heparin + Standard treatment

Standard treatment

Arm Description

Participants will receive the standard treatment and methylprednisolone.

Participants will receive the standard treatment and full-dose heparin,

Participants will receive the standard treatment, methylprednisolone and full-dose heparin

Participants will receive the standard treatment

Outcomes

Primary Outcome Measures

Rate of invasive mechanical ventilation

Secondary Outcome Measures

Severity assessment by ordinal severity scale
Severity assessment will be performed using the ordinal severity scale during hospitalization.
Severity assessment by SOFA score
Severity assessment will be performed using the SOFA score during hospitalization.
Length of hospital stay
Length of stay in intensive care
Death rate

Full Information

First Posted
July 20, 2020
Last Updated
August 4, 2021
Sponsor
D'Or Institute for Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT04485429
Brief Title
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia
Official Title
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
It was not possible to perform the study due to the availability and logistics of porcine heparin
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Heparin, Methylprednisolone, Anticoagulation, Coagulopathy, Respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone + Standard treatment
Arm Type
Experimental
Arm Description
Participants will receive the standard treatment and methylprednisolone.
Arm Title
Full-dose heparin + Standard treatment
Arm Type
Experimental
Arm Description
Participants will receive the standard treatment and full-dose heparin,
Arm Title
Methylprednisolone + Full-dose heparin + Standard treatment
Arm Type
Experimental
Arm Description
Participants will receive the standard treatment, methylprednisolone and full-dose heparin
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Participants will receive the standard treatment
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of invasive mechanical ventilation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Severity assessment by ordinal severity scale
Description
Severity assessment will be performed using the ordinal severity scale during hospitalization.
Time Frame
3 days, 7 days, 14 days, 28 days after randomization
Title
Severity assessment by SOFA score
Description
Severity assessment will be performed using the SOFA score during hospitalization.
Time Frame
3 days, 7 days, 14 days, 28 days after randomization
Title
Length of hospital stay
Time Frame
28 days
Title
Length of stay in intensive care
Time Frame
28 days
Title
Death rate
Time Frame
14 days, 28 days, 60 days, 90 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo M Rego, MD, PhD
Organizational Affiliation
D'Or Institute for Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
D'Or Institute for Research and Education
City
Rio de Janeiro
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35244208
Citation
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
Results Reference
derived

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

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