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

NCT ID: NCT05679414

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2022-11-30

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

Intervention Type: DIAGNOSTIC_TEST

Venous blood sample

Control group

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

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

Intervention Type: DIAGNOSTIC_TEST

Venous blood sample

Interventions

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

Venous blood sample

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Eman Badawy AbdelFattah

Associate professor of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman B AbdelFattah, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R 130/2022

Identifier Type: -

Identifier Source: org_study_id