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

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ClinicalTrials.gov Identifier: NCT04485429
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Methylprednisolone Drug: Heparin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study
Estimated Study Start Date : July 20, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Methylprednisolone + Standard treatment
Participants will receive the standard treatment and methylprednisolone.
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.

Experimental: Full-dose heparin + Standard treatment
Participants will receive the standard treatment and full-dose heparin,
Drug: 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.

Experimental: Methylprednisolone + Full-dose heparin + Standard treatment
Participants will receive the standard treatment, methylprednisolone and full-dose heparin
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.

Drug: 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.

No Intervention: Standard treatment
Participants will receive the standard treatment



Primary Outcome Measures :
  1. Rate of invasive mechanical ventilation [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Severity assessment by ordinal severity scale [ Time Frame: 3 days, 7 days, 14 days, 28 days after randomization ]
    Severity assessment will be performed using the ordinal severity scale during hospitalization.

  2. Severity assessment by SOFA score [ Time Frame: 3 days, 7 days, 14 days, 28 days after randomization ]
    Severity assessment will be performed using the SOFA score during hospitalization.

  3. Length of hospital stay [ Time Frame: 28 days ]
  4. Length of stay in intensive care [ Time Frame: 28 days ]
  5. Death rate [ Time Frame: 14 days, 28 days, 60 days, 90 days after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485429


Contacts
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Contact: Eduardo M Rego, MD, PhD 55 16 981110090 edumrego@hotmail.com
Contact: Abel Costa Neto, MD 55 11 964999091 anetoc@gmail.com

Locations
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Brazil
D'Or Institute for Research and Education Recruiting
Rio de Janeiro, Brazil
Contact: Eduardo M Rego, MD, PhD         
Principal Investigator: Eduardo M Rego, MD, PhD         
Sponsors and Collaborators
D'Or Institute for Research and Education
Investigators
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Principal Investigator: Eduardo M Rego, MD, PhD D'Or Institute for Research and Education
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Responsible Party: D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT04485429    
Other Study ID Numbers: 31180820600005249
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by D'Or Institute for Research and Education:
SARS-CoV-2
Heparin
Methylprednisolone
Anticoagulation
Coagulopathy
Respiratory failure
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Heparin
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action