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

May 11, 2022 updated by: Arya Mani, Yale University
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.

Study Overview

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Camostat mesylate 200 mg
Participants will be given Camostat mesylate three times daily.
Participants will be given Camostat mesylate three times daily.
Placebo Comparator: Microcrystalline Cellulose
Participants will be given placebo three times daily.
Participants will be given Microcrystalline Cellulose (placebo) three times daily.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in plasma D-Dimer
Time Frame: 7 days
The sum percent change in D-Dimer over 7 days will be compared to day 1
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Safety and adverse event
Time Frame: 3 months
The first assessment on mortality and complications will be carried out 3 months after the start of the study.
3 months
Change in plasma Fibrinogen levels
Time Frame: 7 days
Percent change in fibrinogen over 7 days compared to day 1
7 days
Change in plasma troponin
Time Frame: 7 days
Percent change in troponin over 7 days compared to day 1
7 days
New onset cardiomyopathy
Time Frame: 7 days
New onset cardiomyopathy defined by a reduction of EF by greater than 10% or less than 45% will be measured
7 days
Duration of intubation
Time Frame: 7 days
Days with hypoxia (Room Air O2 Sat<93%) or days intubated
7 days
Length of stay in the intensive care unit
Time Frame: 28 days
The number of days in the intensive care unit
28 days
Time to discharge from hospital
Time Frame: 30 days
The number of days since admission to discharge
30 days
Occurrence of major adverse cardiovascular events
Time Frame: 7 days
The ocurrence of major adverse cardiovascular events (MACE): MI, stroke, CHF, PCI, death from cardiovascular disease will be studied.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Arya Mani, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Study protocol and clinical study report will be shared 1 year after completion of the study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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