Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in COVID-19patients

COVID 19 Associated Coagulopathy Clinical Trial

— (MTHFR)C677T  

Official title:

Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in Egyptian Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05679414
• Other study ID #: FMASU R 130/2022
• Status: Completed
• Start date: May 11, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients diagnosed as COVID -19 by RT-PCR will be included

Exclusion Criteria:

• Patients younger than 18 years old Patients on Antithrombotic treatment before COVID-19.

Related Conditions & MeSH terms

• COVID 19 Associated Coagulopathy
• COVID-19

Intervention

Diagnostic Test:
• RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes
Venous blood sample

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of vascular thrombotic manifestation	Level of D. dimer, Lower Limb duplex, or CT chest with Puplomary Angiography if needed.	4 weeks