Evaluation of Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19
Phase 1
- Conditions
- Patients hospitalized for COVID-19 and enrolled within 72 hours of hospital admittance or 72 hours of positive COVID testMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-004285-19-IT
- Lead Sponsor
- CONSORZIO FUTURO IN RICERCA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
= 18 years of age
Hospitalized for COVID-19*
Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
Expected to require hospitalization for > 72 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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000
Exclusion Criteria
Imminent death
Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 21 Day Organ-Support free-days.;Secondary Objective: A composite endpoint of death, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke during hospitalization or at 28 days after enrollment (whichever is earlier);Primary end point(s): 21 Day Organ-Support free-days.;Timepoint(s) of evaluation of this end point: 21 days from inclusion
- Secondary Outcome Measures
Name Time Method