CoagulopathyNCT04507230
COVID-19 Associated Coagulopathy in Egypt
An observational study of Coagulopathy, run by Assiut University at 1 site in Egypt.
Trial summary
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 commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coagulopathy
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Aug 2020to 31 Oct 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: COVID 19 positive by RT- PCR who are admitted to Assiut University hospitals, Egypt. Age and sex matched controls
Who may be able to join
- patients with COVID 19 positive by RT- PCR
Who cannot join
- no exclusions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of COVID-19 Associated Coagulopathy and Hypercoagulable State in Upper Egypt
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 commonly 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 (DIC) compared to 0.6% of survivors.
Read the detailed description
studying the detailed coagulation screen and second line coagulation parameters including both thrombophilia screen and other acute phase coagulation factors.
- Conditions
- Coagulopathy
- Keywords
- hypercoagulable, COVID-19
- Medical subject headings
- Hemostatic Disorders, Thrombophilia, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulation screen
Full coagulation screen
Measured: 1 month
Thrombophilia screen
Full thrombophilia screen
Measured: 1 month
VWF, FVIII
VWFAg, FVIII
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start7 Aug 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
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 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 106 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
- NCT04507230
- Sponsor's protocol ID
- 17300413
- Status last verified
- Mar 2021
- First submitted
- 7 Aug 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of COVID-19 Associated Coagulopathy and Hypercoagulable State in Upper Egypt
- ClinicalTrials.gov ID
- NCT04507230
- Acronym / sponsor ID
- 17300413
- Conditions
- Coagulopathy
- Keywords
- hypercoagulable, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 11 Aug 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.
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 commonly 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 (DIC) compared to 0.6% of survivors.
Detailed description
studying the detailed coagulation screen and second line coagulation parameters including both thrombophilia screen and other acute phase coagulation factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COVID 19 positive by RT- PCR who are admitted to Assiut University hospitals, Egypt. Age and sex matched controls
Key inclusion criteria (1 listed)
- patients with COVID 19 positive by RT- PCR
Key exclusion criteria (1 listed)
- no exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coagulation screen
Time frame: 1 month
Full coagulation screen
Thrombophilia screen
Time frame: 1 month
Full thrombophilia screen
VWF, FVIII
Time frame: 1 month
VWFAg, FVIII
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 11 Mar 2021.
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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 Coagulopathy, 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 11 Mar 2021. 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?
Coagulation screen (time frame: 1 month). The study lists 3 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 11 Mar 2021.