COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80

Frank C Sciurba

Status and phase: Terminated; Phase 3

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Apixaban 2.5 MG; Drug: Aspirin; Drug: Apixaban 5MG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04498273

ACTIV4-Outpatient

Details and patient eligibility

About

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

Full description

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.

Enrollment: 657 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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

Exclusion:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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657 participants in 4 patient groups, including a placebo group

Apixaban 2.5mg

Active Comparator group

Description:

Anticoagulation: prophylactic dose Apixaban 2.5mg po bid

Treatment:

Drug: Apixaban 2.5 MG

Apixaban 5mg

Active Comparator group

Description:

Anticoagulation: therapeutic dose Apixaban 5.0mg po bid

Treatment:

Drug: Apixaban 5MG

Aspirin

Active Comparator group

Description:

Antiplatelet agent: low dose aspirin 81mg po qd

Treatment:

Drug: Aspirin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo