Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis

Official Title

COVID-19 Outpatient Thrombosis Prevention Trial: A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID-19 Adults Not Requiring Hospitalization at Time of Diagnosis

Details

The COVID-19 Outpatient Thrombosis Prevention Trial is a multi-center adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anti-coagulation with anti-platelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who have evidence of increased inflammation based on elevated D-dimer and hsCRP levels, yet are not admitted to hospital as COVID-19 related symptoms are currently stable. Participants will all be adults between 40 and 79 years who will be enrolled from approximately 100 facilities, such as emergency rooms and other settings where a physician is present to evaluate the patient for inclusion and exclusion criteria.

Keywords

COVID-19 Thrombosis Aspirin Apixaban Apixaban 2.5 MG Apixaban 5MG Apixaban 2.5mg

Eligibility

For people ages 40-80

Inclusion:

  • COVID-19+ in past 14 days
  • Platelets > 100,000
  • eGFR > 30ml/min

Exclusion:

  • Hospitalized
  • Contradiction/ other indication for anti-coagulation
  • Pregnancy
  • Active cancer

Locations

  • Zuckerberg San Francisco General accepting new patients
    San Francisco California 94143 United States
  • Stanford University School of Medicine accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Frank C Sciurba
ID
NCT04498273
Phase
Phase 3
Study Type
Interventional
Last Updated