Clinical Trial TitleA Multicenter Adaptive Randomized Double-Blind Placebo Controlled Platform Trial of the Efficacy and Safety of Antithrombotic Strategies in COVID-19 Adults not Requiring Hospitalization at Time of Diagnosis
National Clinical Trial Number:29462823.0
Clinical Trial Protocol Description:
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.
For outpatients not meeting eligibility criteria or who decline to participate in active treatment, participation in a registry component of this trial will be available, with a single follow up 45 days from entry.
Biobanking of samples to assess biomarkers of inflammation and coagulation will be available for centers able to participate in collection from eligible patients.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are an adult 40 to 80 years of age found to be COVID-19 positive and do not require hospitalization due to stable COVID-19 related symptoms status.
Participants will be enrolled from a variety of different facilities where (a) a clinician can evaluate the patient for inclusion and exclusion criteria, and (b) where blood samples can be arranged to be sent for D-dimer, hsCRP, calculated creatinine clearance, and platelet count. COVID-19 testing needs to be confirmed positive within the past 14 days. Serum or urine pregnancy test results will be required for women of childbearing potential before starting study treatment.
You will be excluded from the study if any of the following criteria apply to you:
- Have a contraindication to or requirement for anticoagulant/antithrombotic therapy.
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.