Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coagulation Disorder
- COVID-19
- Pneumonia
- Pulmonary Embolism
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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 inclus...
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.
Tracking Information
- NCT #
- NCT04508439
- Collaborators
- Not Provided
- Investigators
- Not Provided
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