Open Actively Recruiting

Anti-thrombotics for Adults Hospitalized With COVID-19 (ACTIV-4)

About

Brief Summary

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Exclusion Criteria:

  • Imminent death
  • Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
  • Pregnancy
    • Based on a recommendation from the ACTIV4 DSMB on December 19, 2020, enrollment of patients requiring ICU level of care into the therapeutic anti-coagulation arm was stopped due to meeting a futility threshold and a potential for harm for this sub-group could not be excluded. Enrollment continues for moderately ill hospitalized COVID-19 patients.

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Study Stats
Protocol No.
20-002070
Category
Emergency Medicine
Treatment for Hospitalized Patients
Contact
Julia Vargas
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04505774
For detailed technical eligibility, visit ClinicalTrials.gov.