COVID-19 Post-hospital Thrombosis Prevention Study

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002298-25-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Universitario La Paz (FIBHULP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-27
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5320

Inclusion Criteria

• Age = 18 years
• PCR-positive COVID-19 infection
• Hospitalized for 48 or more hours
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2660
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2660

Exclusion Criteria

• Existing indication for anticoagulation, either therapeutic or prophylactic dose
• Contraindication to antithrombotic therapy, such as
a) ischemic stroke, intracranial bleed, or neurosurgery within 3 months
b) Known bleeding within the last 30 days requiring emergency room presentation of hospitalization
c) Known major surgery with 14 days (at least 1 hour and/or requires general anesthesia)
d) Inherited or acquired active bleeding disorder
• Platelet count < 50,000/mcL
• Hemoglobin < 8 gm/dL
• Renal insufficiency (eGFR < 30 mL/min/1.73 m2)
• Pregnancy
• Prison inmate
• Life expectancy less than 90 days
• Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol
• Dual antiplatelet therapy that cannot be discontinued
• Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified