NCT04650087

COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT04650087

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

COVID-19 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge

Summary

A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

Eligibility

Inclusion Criteria:

* • Age ≥ 18 years

* PCR-positive COVID-19 infection
* Hospitalized for two or more days

Exclusion Criteria:

* Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)
* Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
* Platelet count \< 50,000/mcL
* Hemoglobin \<8 gm/dL
* Renal insufficiency (eGFR \< 30 mL/min/1.73 m2)
* Pregnancy
* Prison inmate
* Life expectancy less than 90 days
* Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol
* Dual antiplatelet therapy that cannot be discontinued
* Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4

Disease(s) and\or Condition(s)

Covid19

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: DRUG
- Name: Apixaban 2.5 MG
- Description: Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
- Arm Group Labels: Apixaban
- Type: DRUG
- Name: Placebo
- Description: Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
- Arm Group Labels: Placebo

Sponsor

Thomas L. Ortel