COVID 19 Associated Coagulopathy(MTHFR)C677TNCT05679414
Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in COVID-19patients
An observational study of COVID 19 Associated Coagulopathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of the study is to find the prevalence of thrombophilic gene methylene tetrahydrofolate reductase (MTHFR) gene polymorphism in a sample of COVID-19 patients, aiming at early detection of MTHFR mutant patients and guiding preventive therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID 19 Associated Coagulopathy
- What is being tested?
- RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 11 May 2022to 30 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed as COVID -19 by RT-PCR
Who may be able to join
- All adult patients diagnosed as COVID -19 by RT-PCR will be included
Who cannot join
- Patients younger than 18 years old Patients on Antithrombotic treatment before COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in Egyptian Patients With COVID-19
Aim of the study is to find the prevalence of thrombophilic gene methylene tetrahydrofolate reductase (MTHFR) gene polymorphism in a sample of COVID-19 patients, aiming at early detection of MTHFR mutant patients and guiding preventive therapy.
Read the detailed description
The inflammatory component of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) creates a prothrombotic state that necessitates a thrombophylactic strategy for hospitalized patients. Such strategies are difficult to be standardized because certain individuals can have prothrombotic conditions, such as inherited thrombophilia, which predispose them to an additional coagulative risk. Whether outside the hospital or when admitted, patients with inherited thrombophilia need special anticoagulant attention. Identifying such patients, especially in susceptible populations like the Egyptian people, will aid primary providers in risk stratification for choosing the optimal anticoagulation plan. Case-control study which will be conducted on 33 patients who had been diagnosed as COVID-19 at Ain-Shams University isolation Hospitals and 13 healthy controls. Patients will be subjected to: Thorough history taking, Thorough clinical assessment,COVID-19 PCR+/- radiological data collection, Assessment of MTHFR C677T genotypes were determined by RT- PCR of 2 ml EDTA blood sample, Follow up patient for 28 days as regard development of vascular thrombotic manifestation (D. dimer, LL duplex, or CT chest with Pulmonary angiography if needed).
- Conditions
- COVID 19 Associated Coagulopathy
- Being tested
- RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypesDiagnostic test
Venous blood sample
| Study group | Role | What they receive |
|---|---|---|
| Study group | Covid 19 patients in which MTHFR C677T genotypes was determined by RT- PCR of 2 ml EDTA blood sample.Follow up patient for 28 days as regard development of vascular thrombotic manifestation Receives: Diagnostic Test: RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes | |
| Control group | Healthy subjects in which MTHFR C677T genotypes was determined by RT- PCR of 2 ml EDTA blood sample. Receives: Diagnostic Test: RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of vascular thrombotic manifestation
Level of D. dimer, Lower Limb duplex, or CT chest with Puplomary Angiography if needed.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start11 May 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19 Associated CoagulopathyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Badawy AbdelFattah, Ain Shams University
- Investigators
- Eman B AbdelFattah, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679414
- Sponsor's protocol ID
- FMASU R 130/2022
- Acronym
- (MTHFR)C677T
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication maybe shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in Egyptian Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05679414
- Acronym / sponsor ID
- (MTHFR)C677T / FMASU R 130/2022
- Conditions
- COVID 19 Associated Coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 11 Jan 2023 (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.
Aim of the study is to find the prevalence of thrombophilic gene methylene tetrahydrofolate reductase (MTHFR) gene polymorphism in a sample of COVID-19 patients, aiming at early detection of MTHFR mutant patients and guiding preventive therapy.
Detailed description
The inflammatory component of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) creates a prothrombotic state that necessitates a thrombophylactic strategy for hospitalized patients. Such strategies are difficult to be standardized because certain individuals can have prothrombotic conditions, such as inherited thrombophilia, which predispose them to an additional coagulative risk. Whether outside the hospital or when admitted, patients with inherited thrombophilia need special anticoagulant attention. Identifying such patients, especially in susceptible populations like the Egyptian people, will aid primary providers in risk stratification for choosing the optimal anticoagulation plan. Case-control study which will be conducted on 33 patients who had been diagnosed as COVID-19 at Ain-Shams University isolation Hospitals and 13 healthy controls. Patients will be subjected to: Thorough history taking, Thorough clinical assessment,COVID-19 PCR+/- radiological data collection, Assessment of MTHFR C677T genotypes were determined by RT- PCR of 2 ml EDTA blood sample, Follow up patient for 28 days as regard development of vascular thrombotic manifestation (D. dimer, LL duplex, or CT chest with Pulmonary angiography if needed).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypesCovid 19 patients in which MTHFR C677T genotypes was determined by RT- PCR of 2 ml EDTA blood sample.Follow up patient for 28 days as regard development of vascular thrombotic manifestation |
| Control group | – | Diagnostic Test: RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypesHealthy subjects in which MTHFR C677T genotypes was determined by RT- PCR of 2 ml EDTA blood sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as COVID -19 by RT-PCR
Key inclusion criteria (1 listed)
- All adult patients diagnosed as COVID -19 by RT-PCR will be included
Key exclusion criteria (1 listed)
- Patients younger than 18 years old Patients on Antithrombotic treatment before 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 |
|---|---|---|
| RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypesVenous blood sample | Diagnostic test | Control group, Study group |
Primary outcome
development of vascular thrombotic manifestation
Time frame: 4 weeks
Level of D. dimer, Lower Limb duplex, or CT chest with Puplomary Angiography if needed.
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 Jan 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication maybe shared
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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.
Eman B AbdelFattah, MD principal investigator
Ain Shams University
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 19 Associated Coagulopathy, run by Ain Shams 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 Jan 2023. 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?
development of vascular thrombotic manifestation (time frame: 4 weeks). 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 Jan 2023.