Covid19NCT04982263
Blood Coagulation Abnormalities in COVID-19 (Corona Virus Disease-19) Patients
An observational study of Covid19, run by Sohag University at 2 sites in Egypt.
Trial summary
The role of the coagulation parameters in predicting the severity of COVID-19 disease will be assessed Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Blood coagulation profile
- How many people
- 125 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2021to 31 May 2021
- 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: Cases with confirmed COVID 19 disease
Who may be able to join
- ● Confirmed cases with COVID 19
Who cannot join
- ● Known history of blood coagulopathy disorder
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Blood Coagulation Abnormalities in COVID-19 Patients and Correlation With Severity
The role of the coagulation parameters in predicting the severity of COVID-19 disease will be assessed
Read the detailed description
In COVID-19 patients the coagulation parameters Prothrombin concentration (PC), Activated Partial Thromboplastin Time (aPTT), D Dimer, Antithrombin III (ATIII) and Fibrinogen are measured and correlation with disease severity is to be investigated
- Conditions
- Covid19
- Being tested
- Blood coagulation profile
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood coagulation profileDiagnostic test
Venous blood sample for measurement of blood coagulation profile
| Study group | Role | What they receive |
|---|---|---|
| Mild cases | Patients with confirmed COVID-19 and with mild disease Receives: Diagnostic Test: Blood coagulation profile | |
| Severe cases | Patients with confirmed COVID-19 and with severe disease Receives: Diagnostic Test: Blood coagulation profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of disease severity with results of laboratory test
The results of blood coagulation profile will be correlated with degree of severity of illness
Measured: Baseline results of coagulation profile and baseline disease severity assessment
Secondary outcomes (1)
Agreement of abnormalities in coagulation profile with measured inflammatory markers
The inflammatory markers will be measured and correlation with abnormalities in coagulation profile will be assessed
Measured: baseline measurement of inflammatory markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Feb 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohammed Abdelraheem Esmaeel, Sohag University
- Investigators
- Hend mohamed A Esmaeel, M.D, Principal investigator, Sohag Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982263
- Sponsor's protocol ID
- Soh-Med-21-07-34
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
PubMed 32109011Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
PubMed 32073213Terpos E, Ntanasis-Stathopoulos I, Elalamy I, Kastritis E, Sergentanis TN, Politou M, Psaltopoulou T, Gerotziafas G, Dimopoulos MA. Hematological findings and complications of COVID-19. Am J Hematol. 2020 Jul;95(7):834-847. doi: 10.1002/ajh.25829. Epub 2020 May 23.
PubMed 32282949
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Coagulation Abnormalities in COVID-19 Patients and Correlation With Severity
- ClinicalTrials.gov ID
- NCT04982263
- Acronym / sponsor ID
- Soh-Med-21-07-34
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Jul 2021 (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 role of the coagulation parameters in predicting the severity of COVID-19 disease will be assessed
Detailed description
In COVID-19 patients the coagulation parameters Prothrombin concentration (PC), Activated Partial Thromboplastin Time (aPTT), D Dimer, Antithrombin III (ATIII) and Fibrinogen are measured and correlation with disease severity is to be investigated
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild cases | – | Diagnostic Test: Blood coagulation profilePatients with confirmed COVID-19 and with mild disease |
| Severe cases | – | Diagnostic Test: Blood coagulation profilePatients with confirmed COVID-19 and with severe disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases with confirmed COVID 19 disease
Key inclusion criteria (1 listed)
- ● Confirmed cases with COVID 19
Key exclusion criteria (1 listed)
- ● Known history of blood coagulopathy disorder
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 |
|---|---|---|
| Blood coagulation profileVenous blood sample for measurement of blood coagulation profile | Diagnostic test | Mild cases, Severe cases |
Primary outcome
correlation of disease severity with results of laboratory test
Time frame: Baseline results of coagulation profile and baseline disease severity assessment
The results of blood coagulation profile will be correlated with degree of severity of illness
1 secondary outcome
Agreement of abnormalities in coagulation profile with measured inflammatory markers
Time frame: baseline measurement of inflammatory markers
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 29 Jul 2021.
- Background: PubMed 32109011Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
- Background: PubMed 32073213Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
- Background: PubMed 32282949Terpos E, Ntanasis-Stathopoulos I, Elalamy I, Kastritis E, Sergentanis TN, Politou M, Psaltopoulou T, Gerotziafas G, Dimopoulos MA. Hematological findings and complications of COVID-19. Am J Hematol. 2020 Jul;95(7):834-847. doi: 10.1002/ajh.25829. Epub 2020 May 23.
- Individual participant dataSharing planned: Undecided
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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.
Hend mohamed A Esmaeel, M.D principal investigator
Sohag Univesity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Sohag University at 2 sites 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 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
correlation of disease severity with results of laboratory test (time frame: Baseline results of coagulation profile and baseline disease severity assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982263, which also lists 3 linked publications.
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 29 Jul 2021.