NCT05679414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

January 9, 2023

Last Update Submit

January 9, 2023

Conditions

COVID 19 Associated Coagulopathy

Outcome Measures

Primary Outcomes (1)

  • development of vascular thrombotic manifestation

    Level of D. dimer, Lower Limb duplex, or CT chest with Puplomary Angiography if needed.

    4 weeks

Study Arms (2)

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

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

Interventions

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

Venous blood sample

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed as COVID -19 by RT-PCR

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, +2, Egypt

Location

Study Officials

  • Eman B AbdelFattah, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Pulmonary Medicine

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 11, 2023

Study Start

May 11, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication maybe shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 months after publication
Access Criteria
Through the primary investigator e-mail to other interested researchers

Locations

EG(1)