CoagulopathyPhase 1/2NCT04435015
The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
A Phase 1/2 study testing Camostat Mesylate and Microcrystalline Cellulose, NF in people with Coagulopathy and Cardiovascular Complication, run by Yale University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy, Cardiovascular Complication, COVID-19
- What is being tested?
- Camostat Mesylate and Microcrystalline Cellulose, NF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to 31 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Positive COVID-19 test result.
- Diagnosis of COVID-19 associated coagulopathy and cardiac complications based on D-Dimer, fibrinogen, TnT, CTPE, ischemic EKG changes
- Provision of informed consent. In patients with altered mental status consents can be obtained from the power of attorney.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age 18 or older
- Diagnosed with hypoxia requiring intubation or positive air pressure.
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- Diagnose with DVT/PE by ultrasound and CTPE and/or
- Elevated D-Dimer and/or
- Greater than 2-fold increase in TnT
- Ischemic EKG changes with ST depression or elevation more than 1 mm in 2 consecutive leads
- Ability to administer oral medication.
Who cannot join
- GFR<30 mL/min
- Severe bleeding requiring blood transfusion of drop of 5% in HCT.
- Pregnancy or lactation
- Known allergic reactions to components of Camostat mesylate.
- Subjects under age 18
About this study
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.
Read the 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
- Being tested
- Camostat Mesylate, Microcrystalline Cellulose, NF
- Medical subject headings
- Hemostatic Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camostat MesylateDrug
Participants will be given Camostat mesylate three times daily.
Microcrystalline Cellulose, NFDrug
Also called Placebo
Participants will be given Microcrystalline Cellulose (placebo) three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Camostat mesylate 200 mg | Experimental | Participants will be given Camostat mesylate three times daily. Receives: Drug: Camostat Mesylate |
| Microcrystalline Cellulose | Placebo comparator | Participants will be given placebo three times daily. Receives: Drug: Microcrystalline Cellulose, NF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in plasma D-Dimer
The sum percent change in D-Dimer over 7 days will be compared to day 1
Measured: 7 days
Secondary outcomes (8)
Overall Safety and adverse event
The first assessment on mortality and complications will be carried out 3 months after the start of the study.
Measured: 3 months
Change in plasma Fibrinogen levels
Percent change in fibrinogen over 7 days compared to day 1
Measured: 7 days
Change in plasma troponin
Percent change in troponin over 7 days compared to day 1
Measured: 7 days
New onset cardiomyopathy
New onset cardiomyopathy defined by a reduction of EF by greater than 10% or less than 45% will be measured
Measured: 7 days
Duration of intubation
Days with hypoxia (Room Air O2 Sat<93%) or days intubated
Measured: 7 days
Length of stay in the intensive care unit
The number of days in the intensive care unit
Measured: 28 days
Time to discharge from hospital
The number of days since admission to discharge
Measured: 30 days
Occurrence of major adverse cardiovascular events
The ocurrence of major adverse cardiovascular events (MACE): MI, stroke, CHF, PCI, death from cardiovascular disease will be studied.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study startNov 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Arya Mani, Yale University
- Investigators
- Arya Mani, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435015
- Sponsor's protocol ID
- 2000028279
- Status last verified
- May 2022
- First submitted
- 16 Jun 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
- ClinicalTrials.gov ID
- NCT04435015
- Acronym / sponsor ID
- 2000028279
- Conditions
- Coagulopathy, Cardiovascular Complication, COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- Nov 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camostat mesylate 200 mg | Experimental | Drug: Camostat MesylateParticipants will be given Camostat mesylate three times daily. |
| Microcrystalline Cellulose | Placebo comparator | Drug: Microcrystalline Cellulose, NFParticipants will be given placebo three times daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- . Positive COVID-19 test result.
- Diagnosis of COVID-19 associated coagulopathy and cardiac complications based on D-Dimer, fibrinogen, TnT, CTPE, ischemic EKG changes
- Provision of informed consent. In patients with altered mental status consents can be obtained from the power of attorney.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age 18 or older
Key exclusion criteria (5 listed)
- GFR<30 mL/min
- Severe bleeding requiring blood transfusion of drop of 5% in HCT.
- Pregnancy or lactation
- Known allergic reactions to components of Camostat mesylate.
- Subjects under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camostat MesylateParticipants will be given Camostat mesylate three times daily. | Drug | Camostat mesylate 200 mg |
| Microcrystalline Cellulose, NFAlso: PlaceboParticipants will be given Microcrystalline Cellulose (placebo) three times daily. | Drug | Microcrystalline Cellulose |
Primary outcome
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
8 secondary outcomes
Overall Safety and adverse event
Time frame: 3 months
Change in plasma Fibrinogen levels
Time frame: 7 days
Change in plasma troponin
Time frame: 7 days
New onset cardiomyopathy
Time frame: 7 days
Duration of intubation
Time frame: 7 days
Length of stay in the intensive care unit
Time frame: 28 days
Time to discharge from hospital
Time frame: 30 days
Occurrence of major adverse cardiovascular events
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arya Mani, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Camostat Mesylate and Microcrystalline Cellulose, NF in people with Coagulopathy and Cardiovascular Complication, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in plasma D-Dimer (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.