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Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508439
Recruitment Status : Unknown
Verified August 2020 by Omar Ramos-Peñafiel, Hospital Regional de Alta especialidad de Ixtapaluca.
Recruitment status was:  Recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Omar Ramos-Peñafiel, Hospital Regional de Alta especialidad de Ixtapaluca

Study Description
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Brief Summary:

Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms. Multiple pathogenic mechanisms are involved, including endothelial dysfunction, increased von Willebrand factor, Toll receptor activation, and tissue factor pathway activation. D-dimer levels greater than 1000 ng / mL are associated with an 18-fold increased risk of mortality. In this context, many patients may require prophylaxis or antithrombotic treatment with low molecular weight heparins. Currently, there is no validated scheme on the dose and timing of the use of antithrombotic drugs.

The study aims to identify the effect of two anticoagulant strategies (prophylactic and therapeutic) on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care.


Condition or disease Intervention/treatment Phase
Covid19 Pneumonia Coagulation Disorder Pulmonary Embolism Drug: Enoxaparin Not Applicable

Detailed Description:

Randomized clinical trial in patients with a confirmed infection by COVID-19 who require hospital treatment and subsequent ambulatory surveillance.

Study population. Patients with a diagnosis by PCR of COVID 19, over 18 years of age from the High Specialty Hospital of Ixtapaluca, who meet the inclusion criteria.

Statistic analysis. The student's T-test was carried out to identify the difference in the means of the quantitative variables between the groups. A value of P ≤ 0.05, 95% CI will be considered significant. For the hypothesis test, the chi-square test will be performed, considering a p≤ 0.05, 95% CI value to be significant.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
  • Initially they will be randomized into two blocks, the first based on prophylactic Enoxaparin (Numbers 1 to 64) and the second (Numbers 65 to 128) will be assigned to the Enoxaparin therapeutic regimen arm at doses of 1mg / kg/dose twice up to date
  • During hospitalization, the clinical evolution will be evaluated according to the requirements of mechanical ventilation, the reduction in D-Dimer levels and the clinical outcome (discharge or death).
  • Those patients who are discharged will be Randomized in two following treatment arms
  • The allocation of patients in the outpatient stage will be carried out randomly 1: 1 to receive Rivaroxaban 10mg PO every 24hrs or only clinical follow-up.
  • Follow-up of adverse events will be carried out in the Hematology outpatient clinic with a first consultation 15 days after discharge and a second consultation 30 days after discharge. With dimer D, ferritin, protein C, blood count, ESR and on day 30 with CAT.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Actual Study Start Date : June 20, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Prophylactic enexaparin
Enoxaparin dose of 1mg / kg / dose twice daily
 Drug: Enoxaparin
Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the established clinical response due to lack of ventilatory support, length of hospital stay or death in patients requiring hospital care for COVID-19 infection.
Other Name: low molecular weight heparin
Active Comparator: Therapeutic Enoxaparin
Enoxaparin dose of 1mg / kg / dose daily
 Drug: Enoxaparin
Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the established clinical response due to lack of ventilatory support, length of hospital stay or death in patients requiring hospital care for COVID-19 infection.
Other Name: low molecular weight heparin


Outcome Measures
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Primary Outcome Measures :
  1. low molecular weight heparin (enoxaparin) and ventilatory support time [ Time Frame: 30 days ]
    Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on ventilatory support time in patients requiring hospital care for COVID-19 infection.

  2. thrombotic complications and Rivaroxaban [ Time Frame: 30 days ]
    To compare oral anticoagulation therapy by administering Rivaroxaban 10mg PO every 24 hours on early thrombotic complications

  3. low molecular weight heparin (enoxaparin) and length of hospital stay [ Time Frame: 30 days ]
    Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the length of hospital stay in patients requiring hospital care for COVID-19 infection.

  4. low molecular weight heparin (enoxaparin) and mortality rate [ Time Frame: 30 days ]
    Identify the benefit of different doses of low molecular weight heparin (enoxaparin) over mortality rate in patients requiring hospital care for COVID-19 infection.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of COVID-19 infection confirmed by polymerase chain reaction test (RQ-PCR) requiring hospital care for the administration of supplemental oxygen

Exclusion Criteria:

  • Patients with life expectancy less than 48hrs
  • Patients who require ventilatory support upon admission
  • Age over 75 years or with a history of atrial fibrillation
  • History of venous or arterial thrombosis
  • Severe neurological impairment
  • Absence of a primary caregiver to supervise the administration of medication
  • History of cerebral hemorrhage
  • History of previous use of oral anticoagulants
  • History of major surgery 30 days prior to admission
  • Uncontrolled systemic arterial hypertension
  • KDIGO stage III chronic kidney disease or less
  • Hemodialysis or peritoneal dialysis treatment
  • History of active or inactive cancer
  • Pregnant or postpartum patients
Contacts and Locations
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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): NCT04508439


Contacts
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Contact: Omar Ramos-Peñafiel, MD, PhD +525523351588 christian.ramos.penafiel@gmail.com

Locations
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Mexico
Hospital Regional de Alta Especialidad de Ixtapaluca Recruiting
Mexico City, Ixtapaluca, Mexico, 56530
Contact: Omar O Ramos-Peñafiel    5523351588    christian.ramos.penafiel@gmail.com   
Sponsors and Collaborators
Hospital Regional de Alta especialidad de Ixtapaluca
More Information
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Responsible Party: Omar Ramos-Peñafiel, Principal Investigator, Hospital Regional de Alta especialidad de Ixtapaluca
ClinicalTrials.gov Identifier: NCT04508439    
Other Study ID Numbers: NR-CEI-HRAEI-19-2020
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 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
Keywords provided by Omar Ramos-Peñafiel, Hospital Regional de Alta especialidad de Ixtapaluca:
Covid-19
Mortality
anticoagulants
Deep venous thrombosis
Pulmonary embolism
Additional relevant MeSH terms:
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COVID-19
Pulmonary Embolism
Embolism
Hemostatic Disorders
Blood Coagulation Disorders
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Heparin
Enoxaparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action