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Terminated
NCT04634799
Study To antagOnize Plasminogen Activator Inhibitor-1 in Severe COVID-19
Conditions: Covid19
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 9
Sponsor: Northwestern University
Location: Northwestern University Chicago Illinois
Summary
This is a single-center, randomized double blind placebo controlled trial to evaluate the efficacy and safety of novel PAI-1 inhibitor (TM5614) for high-risk patients hospitalized with severe COVID-19 at Northwestern Memorial Hospital. The patients will be randomized in a 1:1 ratio to receive standard of care plus TM5614 or standard of care plus placebo.
Eligibility Criteria
Inclusion Criteria:
1. Adults ≥65 years old or \< 65 years old AND at least one major cardiometabolic comorbidity (diabetes, hypertension, or cardiovascular disease)
2. Established diagnosis of COVID-19 as evidenced by a positive nasopharyngeal or bronchoalveolar lavage viral PCR for SARS-CoV2
3. Requiring supplemental oxygen
Exclusion Criteria:
1. Age \200 persistently \>12 hours)
4. Currently receiving therapeutic dose anticoagulation (specifically will exclude those with potential drug-drug interaction such as heparin, apixaban, warfarin)
5. Platelets \
Source: ClinicalTrials.gov (NCT04634799). StuddyBuddy aggregates publicly available trial information.