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

August 8, 2020 updated by: Omar Ramos-Peñafiel, Hospital Regional de Alta especialidad de Ixtapaluca

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ixtapaluca
      • Mexico City, Ixtapaluca, Mexico, 56530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • low molecular weight heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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
30 days
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.
30 days
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Regional de Alta especialidad de Ixtapaluca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2020

Primary Completion (Anticipated)

August 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR-CEI-HRAEI-19-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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