COVID-19 Outpatient Thrombosis Prevention Trial (ACTIV-4B)

An adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anticoagulation with antiplatelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who are not admitted to hospital as COVID-19 related symptoms are currently stable.]]>
Inclusion criteria:

Age between 40 and 80 years inclusive
Documentation of PCR or antigen test positive symptomatic COVID-19 infection in the past 14 days
Ability to be contacted by telephone or other electronic methods of communication
Negative pregnancy test for WOCBP

Exclusion criteria:

Indication for therapeutic anticoagulation (mechanical heart valve, AF, APS)
Indication for single or dual antiplatelet therapy
Lactating
Primary brain tumor or acute leukemia
Bleeding risk
Hospitalization in the past 2 months for:

Bleeding due to ulcer or GI tract disease
Major surgery, stroke, or intracranial hemorrhage

Platelet count < 100,000 per microliter can be obtained after randomization
Calculated creatine clearance < 30 ml/min can be obtained after randomization
Ever hospitalized after diagnosis of COVID-19
Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
SARS-CoV-2 PCR or antigen test more than 14 days prior
Unable to give written informed consent

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