The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this study is to determine whether Camostat mesylate reduces SARS-COV-2 associated coagulopathy. Additional aims are to determine the effect of Camostat mesylate on SARS-COV-2 associated myocardial injury, to assess duration of hypoxia or intubation, to evaluate the length of intensive care unit and hospital stay, and assess mortality rates.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Camostat

Criteria

Inclusion Criteria:

1. . Positive COVID-19 test result.

2. Diagnosis of COVID-19 associated coagulopathy and cardiac complications based on D-Dimer, fibrinogen, TnT, CTPE, ischemic EKG changes

3. Provision of informed consent. In patients with altered mental status consents can be obtained from the power of attorney.

4. Stated willingness to comply with all study procedures and availability for the duration of the study

5. Male or female, age 18 or older

6. Diagnosed with hypoxia requiring intubation or positive air pressure.

7. Diagnose with DVT/PE by ultrasound and CTPE and/or

8. Elevated D-Dimer and/or

9. Greater than 2-fold increase in TnT

10. Ischemic EKG changes with ST depression or elevation more than 1 mm in 2 consecutive leads

11. Ability to administer oral medication.

Exclusion Criteria:

1. GFR<30 mL/min

2. Severe bleeding requiring blood transfusion of drop of 5% in HCT.

3. Pregnancy or lactation

4. Known allergic reactions to components of Camostat mesylate.

5. Subjects under age 18