NCT04634799

Study to AntagOnize Plasminogen Activator Inhibitor-1 in Severe COVID-19

Study to AntagOnize Plasminogen Activator Inhibitor-1 in Severe COVID-19 (STOP Severe COVID-19)

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This project will evaluate the efficacy and safety of a novel small molecule therapy targeting PAI-1 (TM5614) for patients with severe COVID-19. This is a randomized (1:1), double-blinded trial that will enroll adult patients (\> 65 years OR \<65 years with at least one major cardiometabolic comorbidity \[diabetes, hypertension, or cardiovascular disease\]) with COVID-19 requiring supplemental oxygen. The study intervention will be a small molecule inhibitor of PAI-1, TM5614, up to 180 mg, compared to matching placebo for up to 7 days. Research blood samples for PAI-1 and C-reactive protein (CRP) will be collected at time of enrollment, 48 hours after 1st dose of medication and at day 7 or discharge, whichever comes first. These objectives will allow for the planning of subsequent phase 3 study, and strengthen implementation of a multi-center randomized trial should this study confirm safety, and suggest efficacy of therapy.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	TM5614	TM5614 is provided in 30 mg tablets and 6 tablets (180 mg) will be taken in the evening for up to 7 days.
OTHER	Placebo	Matching placebo will be provided and participants will take 6 tablets in the evening for up to 7 days.

Timeline

• Start date: 2021-01-08
• Primary completion: 2025-04-23
• Completion: 2025-05-30
• First posted: 2020-11-18
• Last updated: 2025-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study