COVIDNCT04460664
Coagulation Changes Associated With COVID-19 Infection
An observational study of COVID and Disseminated Intravascular Coagulation, run by HemoSonics LLC at 1 site in United States.
Trial summary
This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Disseminated Intravascular Coagulation, Coagulation Disorder
- What is being tested?
- Quantra System
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 26 Jan 2022
- Phase
- Observational
- 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
Study population: Potential subjects will be adult (>=18 years) patients with a diagnosis of COVID-19 disease admitted to the hospital for treatment of their disease. Subjects will be enrolled at a ratio of 1 admitted to floor for every 2 admitted to ICU as initial place of hospitalization.
Who may be able to join
- Subject is ≥ 18 years of age
- Subject has a diagnosis of COVID-19 and has been admitted to the hospital
- Subject has one or more risk factors for a poor outcome with COVID-10 disease: advanced age (>=60 years), morbid obesity, diabetes, COPD, CAD
- Subject, or subject's legally authorized representative is willing and agrees to provide informed consent.
Who cannot join
- Subject is younger than 18 years of age
- Subject is pregnant
- Subject is incarcerated.
- Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
- Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
About this study
Official title: Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.
Read the detailed description
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QPlus Cartridge can measure hypocoagulable and hypercoagulable conditions resulting from the functional interaction of the enzymatic and cellular components of coagulation and therefore, can be invaluable for longitudinal monitoring of the coagulopathies reported in COVID-19 patients and the response to anticoagulants.
This single-center, prospective, observational pilot study will characterize changes in the coagulation status of patients with COVID-19 infection during their hospital stay using the Quantra QPlus System.
- Being tested
- Quantra System
- Keywords
- Viscoelastic testing, Quantra, COVID-19
- Medical subject headings
- Disseminated Intravascular Coagulation, Hemostatic Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra SystemDiagnostic test
Also called QPlus Cartridge
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Subjects admitted to floor | COVID-19 patients admitted to the floor as initial place of hospitalization Receives: Diagnostic Test: Quantra System | |
| Subjects admitted or transferred to ICU | COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor Receives: Diagnostic Test: Quantra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantra Clot Time results
Coagulation function assessed by the Quantra
Measured: Within 24 hours of admission to the hospital
Quantra Clot Time results
Coagulation function assessed by the Quantra
Measured: 48 to 72 hours after transfer to ICU
Quantra Clot Time results
Coagulation function assessed by the Quantra
Measured: 1 to 24 hours prior to discharge from hospital
Quantra Clot Stiffness results
Coagulation function assessed by the Quantra
Measured: Upon arrival at hospital
Quantra Clot Stiffness results
Coagulation function assessed by the Quantra
Measured: 48 to 72 hours after transfer to ICU
Quantra Clot Stiffness results
Coagulation function assessed by the Quantra
Measured: 1 to 24 hours prior to discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start14 Aug 2020
- Primary completion28 Apr 2021
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460664
- Sponsor's protocol ID
- HEMCS-035
- Status last verified
- May 2022
- First submitted
- 30 Jun 2020
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04460664
- Acronym / sponsor ID
- HEMCS-035
- Keywords
- Viscoelastic testing, Quantra, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 7 Jul 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.
This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.
Detailed description
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QPlus Cartridge can measure hypocoagulable and hypercoagulable conditions resulting from the functional interaction of the enzymatic and cellular components of coagulation and therefore, can be invaluable for longitudinal monitoring of the coagulopathies reported in COVID-19 patients and the response to anticoagulants.
This single-center, prospective, observational pilot study will characterize changes in the coagulation status of patients with COVID-19 infection during their hospital stay using the Quantra QPlus System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects admitted to floor | – | Diagnostic Test: Quantra SystemCOVID-19 patients admitted to the floor as initial place of hospitalization |
| Subjects admitted or transferred to ICU | – | Diagnostic Test: Quantra SystemCOVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects will be adult (>=18 years) patients with a diagnosis of COVID-19 disease admitted to the hospital for treatment of their disease. Subjects will be enrolled at a ratio of 1 admitted to floor for every 2 admitted to ICU as initial place of hospitalization.
Key inclusion criteria (4 listed)
- Subject is ≥ 18 years of age
- Subject has a diagnosis of COVID-19 and has been admitted to the hospital
- Subject has one or more risk factors for a poor outcome with COVID-10 disease: advanced age (>=60 years), morbid obesity, diabetes, COPD, CAD
- Subject, or subject's legally authorized representative is willing and agrees to provide informed consent.
Key exclusion criteria (5 listed)
- Subject is younger than 18 years of age
- Subject is pregnant
- Subject is incarcerated.
- Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
- Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
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 |
|---|---|---|
| Quantra SystemAlso: QPlus CartridgeDiagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. | Diagnostic test | Subjects admitted or transferred to ICU, Subjects admitted to floor |
Primary outcome
Quantra Clot Time results
Time frame: Within 24 hours of admission to the hospital
Coagulation function assessed by the Quantra
Quantra Clot Time results
Time frame: 48 to 72 hours after transfer to ICU
Coagulation function assessed by the Quantra
Quantra Clot Time results
Time frame: 1 to 24 hours prior to discharge from hospital
Coagulation function assessed by the Quantra
Quantra Clot Stiffness results
Time frame: Upon arrival at hospital
Coagulation function assessed by the Quantra
Quantra Clot Stiffness results
Time frame: 48 to 72 hours after transfer to ICU
Coagulation function assessed by the Quantra
Quantra Clot Stiffness results
Time frame: 1 to 24 hours prior to discharge from hospital
Coagulation function assessed by the Quantra
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Disseminated Intravascular Coagulation, run by HemoSonics LLC at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantra Clot Time results (time frame: Within 24 hours of admission to the hospital). The study lists 6 primary outcomes in all. 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 13 May 2022.