Clinical Trial TitleCOVID-19 Post-hospital Thrombosis Prevention Study: A multicenter, adaptive, prospective, randomized, placebo-controlled platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge
National Clinical Trial Number:NCT04650087
Clinical Trial Protocol Description:
The purpose of this study is to compare the effectiveness and safety of antithrombotic therapy (blood thinner medication) with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19.
Clinical Trial Eligibility Criteria:
The inclusion criteria for Stage 1 of this adaptive protocol are listed below. Potential study participants will be identified during hospitalization and reviewed for inclusion/exclusion criteria. Per the adaptive trial design strategy, these criteria may change after the first and subsequent analyses of in-trial accrued data.
In order to participate you must meet the following criteria:
- Are at least 18 years age.
- Have a PCR-positive COVID-19 infection.
- Have been hospitalized for 48 or more hours.
The exclusion criteria for Stage 1 of this adaptive protocol are listed below. These are potentially subject to change based on the adaptive trial design and analyses of in-trial accrued data.
You will be excluded from the study if any of the following criteria apply to you:
- Have existing indication for anticoagulation, either therapeutic or prophylactic dose.
- Have contraindication to antithrombotic therapy, such as the following:
- Ischemic stroke, intracranial bleed, or neurosurgery within 3 months
- Known bleeding within the last 30 days requiring emergency room presentation or hospitalization
- Known major surgery within 14 days (at least 1 hour and/or requires general anesthesia)
- Inherited or active acquired bleeding disorder
- Have a platelet count < 50,000/mcL.
- Have hemoglobin < 8 gm/dL.
- Are pregnant.
- Are a prison inmate.
- Have a life expectancy less than 90 days.
- Are unwilling or unable to provide informed consent.
- Are unwilling or unable to complete the study protocol.
- Other criteria related to arm-specific appendices developed as adaptations to the trial.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.