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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05679414

Collaborator

(none)

Enrollment

Location

6.7

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID 19 Associated Coagulopathy	Diagnostic Test: RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes

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

Study Type:

Observational

Actual Enrollment :

46 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 11, 2022

Actual Primary Completion Date :

Nov 30, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Diagnostic Test: RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes Venous blood sample
Control group Healthy subjects in which MTHFR C677T genotypes was determined by RT- PCR of 2 ml EDTA blood sample.	Diagnostic Test: RT- PCR of 2 ml EDTA blood sample to determine MTHFR C677T genotypes Venous blood sample

Arm

Intervention/Treatment

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

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

Venous blood sample

Control group

Healthy subjects in which MTHFR C677T genotypes was determined by RT- PCR of 2 ml EDTA blood sample.

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

Venous blood sample

Outcome Measures

Primary Outcome Measures

development of vascular thrombotic manifestation [4 weeks]
Level of D. dimer, Lower Limb duplex, or CT chest with Puplomary Angiography if needed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt	+2

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Eman B AbdelFattah, MD, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Badawy AbdelFattah, Associate professor of Pulmonary Medicine, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05679414

Other Study ID Numbers:

FMASU R 130/2022

First Posted:

Jan 11, 2023

Last Update Posted:

Jan 11, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 11, 2023