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

NCT ID: NCT04435015

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2021-12-31

Brief 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.

Detailed Description

The trial is in-patient only. Participants are identified by the hospital physicians and house staff, and contacted by research study personnel. Potential participants fulfilling inclusion criteria and not fulfilling exclusion criteria who agree to participate and sign the informed consent undergo the enrollment process. Ono Pharmaceutical, Japan, will provide Camostat mesylate tablets. The Yale New Haven Hospital research pharmacy will receive and store the drug within 15-25C range according to protocol storage requirements.

Microcrystalline Cellulose NF (PH-102) for placebo formulation will be acquired from Fagron. Empty gelatin capsules Size 0, for over-encapsulation will be acquired from Fagron. Before Ono Pharmaceutical can send the drug, an IND will be obtained from the FDA.

Principal Investigator and the Yale New Haven Hospital research pharmacy will keep accountability records for all investigational products acquired, dispensed, used and disposed. Drugs are administered by nurses. There will be no restriction on taking other medications, activities or food intake. There are two arms to the study: (a) pharmacy-formulated placebo 3 times a day (b) 200 mg Camostat mesylate to be taken three times daily. Each arm will have 100 subjects. All patients will receive treatment until discharged. Participants will be randomized equally to Camostat mesylate or identical appearing placebo using a permuted-block design with variable block size. The actual treatment assignment will be concealed from the investigators and the participants. The randomization scheme will be generated by the statistical group.

Participants have the option of refusing study drug. If the participant decides to stop the drug or blood drawing he or she would be dropped from the trial.

Conditions

Coagulopathy; Cardiovascular Complication; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Camostat mesylate 200 mg

Participants will be given Camostat mesylate three times daily.

Group Type: EXPERIMENTAL

Camostat Mesylate

Intervention Type: DRUG

Participants will be given Camostat mesylate three times daily.

Microcrystalline Cellulose

Participants will be given placebo three times daily.

Group Type: PLACEBO_COMPARATOR

Microcrystalline Cellulose, NF

Intervention Type: DRUG

Participants will be given Microcrystalline Cellulose (placebo) three times daily.

Interventions

Camostat Mesylate

Participants will be given Camostat mesylate three times daily.

Intervention Type: DRUG

Microcrystalline Cellulose, NF

Participants will be given Microcrystalline Cellulose (placebo) three times daily.

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Arya Mani

Professor of Medicine and of Genetics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arya Mani, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

2000028279

Identifier Type: -

Identifier Source: org_study_id