EUCTR2020-002282-33-DE
Active, Not Recruiting
Phase 1
Effect of anticoagulation therapy on clinical outcomes in COVID-19 (COVID-PREVENT)
Charité - Universitaetsmedizin Berlin0 sites400 target enrollmentMay 29, 2020
DrugsXarelto
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Charité - Universitaetsmedizin Berlin
- Enrollment
- 400
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject must be willing, understanding and able to provide written informed consent
- •2\. Subject must be a man or a woman with age \> 18 years at screening
- •3\. Subject must have an active moderate to severe COVID\-19 confirmed by
- •a. A positive SARS\-CoV\-2 PCR test in the last 14 days
- •4\. At least one of the following features should be present
- •a. D\-Dimer elevation \> 1\.5 ULN (age adjusted cut\-offs) AND/OR
- •b. Cardiac injury reflected by an elevation in hs\-cTnT \> 2\.0 ULN AND at least one of the following conditions:
- •i. Known CAD
- •ii. Known diabetes mellitus
- •iii. Active smoking
Exclusion Criteria
- •Any potential subject who meets any of the following criteria will be excluded from participating in the study.
- •1\. Subject has a very high bleeding risk: Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:
- •a. Any bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 1 months prior to randomization or occurring during index hospitalization.
- •b. Major surgery, biopsy of a parenchymal organ, ophthalmic surgery (excluding cataract surgery), or serious trauma (including head trauma) within 4 weeks before randomization.
- •c. A history of hemorrhagic stroke or any intracranial bleeding at any time in the past, evidence of primary intracranial hemorrhage on CT or magnetic resonance imaging scan of the brain, or clinical presentation consistent with intracranial hemorrhage. This applies as well to subjects hospitalized for ischemic stroke upon randomization.
- •d. Subject has a history of or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm.
- •e. Active gastroduodenal ulcer, defined as diagnosed within 1 months or currently symptomatic or known AV malformations of the gastrointestinal tract.
- •f. Platelet count \<90,000/µl at screening.
- •g. Patients with the diagnosis of bronchiectasis, that due to the investigator judgement are at an increased bleeding risk.
- •2\. Subject has any of the following diseases in the medical history:
Outcomes
Primary Outcomes
Not specified
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