Coagulation DisorderNCT04479280
Evaluation of Coagulopathy in Critically Ill COVID-19 Patients.
An observational study of Coagulation Disorder, run by Assiut University at 1 site in Egypt.
Trial summary
Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2020to 16 Aug 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who are suspected to be COVID 19 infection
Who may be able to join
- COVID 19 critically ill patients
Who cannot join
- any critical illness not related to COVID 19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Sonoclot Signature in Assessment of Coagulopathy in Critically Ill COVID 19 Patients
Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world .
Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation
- Conditions
- Coagulation Disorder
- Being tested
- Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USADevice
studying coagulation disorders in COVID19 critically ill patients
| Study group | Role | What they receive |
|---|---|---|
| Covid19 positive patients | Not described Receives: Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA | |
| Covid19 negative patients | Not described Receives: Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
clot rate formation
measuring how rapid the sample will get clotted
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start20 Jul 2020
- Primary completion16 Aug 2020
- Study completion16 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Abdelaal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479280
- Sponsor's protocol ID
- 17300446
- Status last verified
- Sep 2020
- First submitted
- 19 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Sonoclot Signature in Assessment of Coagulopathy in Critically Ill COVID 19 Patients
- ClinicalTrials.gov ID
- NCT04479280
- Acronym / sponsor ID
- 17300446
- Conditions
- Coagulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 16 Aug 2020 (actual)
- First posted
- 21 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.
Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world .
Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid19 positive patients | – | Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA |
| Covid19 negative patients | – | Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who are suspected to be COVID 19 infection
Key inclusion criteria (1 listed)
- COVID 19 critically ill patients
Key exclusion criteria (1 listed)
- any critical illness not related to COVID 19
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 |
|---|---|---|
| Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USAstudying coagulation disorders in COVID19 critically ill patients | Device | Covid19 negative patients, Covid19 positive patients |
Primary outcome
clot rate formation
Time frame: 30 minutes
measuring how rapid the sample will get clotted
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 9 Sep 2020.
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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 Coagulation Disorder, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 9 Sep 2020. 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 Egypt. 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?
clot rate formation (time frame: 30 minutes). 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 9 Sep 2020.