Back to resultsEffect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Primary Purpose
Covid19, Pneumonia, Coagulation Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid-19, Mortality, anticoagulants, Deep venous thrombosis, Pulmonary embolism
Eligibility 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
Sites / Locations
- Hospital Regional de Alta Especialidad de IxtapalucaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prophylactic enexaparin
Therapeutic Enoxaparin
Arm Description
Enoxaparin dose of 1mg / kg / dose twice daily
Enoxaparin dose of 1mg / kg / dose daily
Outcomes
Primary Outcome Measures
low molecular weight heparin (enoxaparin) and ventilatory support time
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.
thrombotic complications and Rivaroxaban
To compare oral anticoagulation therapy by administering Rivaroxaban 10mg PO every 24 hours on early thrombotic complications
low molecular weight heparin (enoxaparin) and length of hospital stay
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.
low molecular weight heparin (enoxaparin) and mortality rate
Identify the benefit of different doses of low molecular weight heparin (enoxaparin) over mortality rate in patients requiring hospital care for COVID-19 infection.
Secondary Outcome Measures
Full Information
NCT ID
NCT04508439
First Posted
August 5, 2020
Last Updated
August 8, 2020
Sponsor
Hospital Regional de Alta especialidad de Ixtapaluca
1. Study Identification
Unique Protocol Identification Number
NCT04508439
Brief Title
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Official Title
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Regional de Alta especialidad de Ixtapaluca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Pneumonia, Coagulation Disorder, Pulmonary Embolism
Keywords
Covid-19, Mortality, anticoagulants, Deep venous thrombosis, Pulmonary embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic enexaparin
Arm Type
Experimental
Arm Description
Enoxaparin dose of 1mg / kg / dose twice daily
Arm Title
Therapeutic Enoxaparin
Arm Type
Active Comparator
Arm Description
Enoxaparin dose of 1mg / kg / dose daily
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
low molecular weight heparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
low molecular weight heparin (enoxaparin) and ventilatory support time
Description
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.
Time Frame
30 days
Title
thrombotic complications and Rivaroxaban
Description
To compare oral anticoagulation therapy by administering Rivaroxaban 10mg PO every 24 hours on early thrombotic complications
Time Frame
30 days
Title
low molecular weight heparin (enoxaparin) and length of hospital stay
Description
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.
Time Frame
30 days
Title
low molecular weight heparin (enoxaparin) and mortality rate
Description
Identify the benefit of different doses of low molecular weight heparin (enoxaparin) over mortality rate in patients requiring hospital care for COVID-19 infection.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Ramos-Peñafiel, MD, PhD
Phone
+525523351588
Email
christian.ramos.penafiel@gmail.com
Facility Information:
Facility Name
Hospital Regional de Alta Especialidad de Ixtapaluca
City
Mexico City
State/Province
Ixtapaluca
ZIP/Postal Code
56530
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar O Ramos-Peñafiel
Phone
5523351588
Email
christian.ramos.penafiel@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
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