Evaluation of Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19

A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 - ACTIVE4-ACUTE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004285-19-IT

Enrollment

2000

Registered

2020-11-23

Start date

2020-11-25

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients hospitalized for COVID-19 and enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: EPARINA Product Code: [B01AB01] Pharmaceutical Form: Current Sponsor code: EPARINA NON FRAZIONATA Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Imminent death Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization Pregnancy

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Italy, Spain, United States

Contacts

Public ContactCONSORZIO FUTURO IN RICERCA

CONSORZIO FUTURO IN RICERCA

cfr@unife.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026