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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-08

Study Completion Date

2025-05-30

Brief Summary

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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.

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Detailed Description

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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

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

double-blind, randomized (1:1)

Study Groups

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TM5614

TM5614 30 mg tablets. 6 tablets (180 mg) taken by mouth, once daily for up to 7 days

Group Type ACTIVE_COMPARATOR

TM5614

Intervention Type DRUG

TM5614 is provided in 30 mg tablets and 6 tablets (180 mg) will be taken in the evening for up to 7 days.

Placebo

Placebo tablets. 6 tablets taken by mouth, once daily for up to 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo will be provided and participants will take 6 tablets in the evening for up to 7 days.

Interventions

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TM5614

TM5614 is provided in 30 mg tablets and 6 tablets (180 mg) will be taken in the evening for up to 7 days.

Intervention Type DRUG

Placebo

Matching placebo will be provided and participants will take 6 tablets in the evening for up to 7 days.

Intervention Type OTHER

Other Intervention Names

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Plasminogen activator inhibitor-1 (PAI-1) TM5614 Placebo

Eligibility Criteria

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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 \<18 years old
2. Pregnancy or breast-feeding
3. Known contraindication to tissue plasminogen activator (tPA), including

1. Active internal bleeding
2. History of cerebrovascular accident
3. Recent intracranial or intraspinal surgery or trauma
4. Intracranial neoplasm, arteriovenous malformation or aneurysm
5. Known bleeding diathesis
6. Severe uncontrolled hypertension (SBP\>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 \<50,000
6. Hematocrit \<30%
7. Not hemodynamically stable in the preceding 4 hours (symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements)
8. Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessment
9. Other patient characteristics (not thought to be related to COVID-19) that portend a very poor prognosis (e.g., severe liver failure, metastatic malignancy)
10. Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
11. Participant's responsible attending physician believes it is not appropriate for participant to participate in the study.
12. Inability or unwillingness to provide written informed consent
13. Involvement in the planning and/or conduct of the study
14. Previous randomization in the present study
15. Unable to complete study procedures.
16. Patients with active venothromboembolic disease
17. Patients who are receiving other investigational agents for COVID-19.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No