Blood Coagulation Abnormalities in COVID-19 (Corona Virus Disease-19) Patients

July 27, 2021 updated by: Hend Mohammed Abdelraheem Esmaeel, Sohag University

Blood Coagulation Abnormalities in COVID-19 Patients and Correlation With Severity

The role of the coagulation parameters in predicting the severity of COVID-19 disease will be assessed

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In COVID-19 patients the coagulation parameters Prothrombin concentration (PC), Activated Partial Thromboplastin Time (aPTT), D Dimer, Antithrombin III (ATIII) and Fibrinogen are measured and correlation with disease severity is to be investigated

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82425
        • Sohag University
      • Sohag, Egypt, 82524
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases with confirmed COVID 19 disease

Description

Inclusion Criteria:

● Confirmed cases with COVID 19

Exclusion Criteria:

● Known history of blood coagulopathy disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild cases
Patients with confirmed COVID-19 and with mild disease
Diagnostic test: Blood coagulation profile
Venous blood sample for measurement of blood coagulation profile
Severe cases
Patients with confirmed COVID-19 and with severe disease
Diagnostic test: Blood coagulation profile
Venous blood sample for measurement of blood coagulation profile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of disease severity with results of laboratory test
Time Frame: Baseline results of coagulation profile and baseline disease severity assessment
The results of blood coagulation profile will be correlated with degree of severity of illness
Baseline results of coagulation profile and baseline disease severity assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of abnormalities in coagulation profile with measured inflammatory markers
Time Frame: baseline measurement of inflammatory markers
The inflammatory markers will be measured and correlation with abnormalities in coagulation profile will be assessed
baseline measurement of inflammatory markers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Hend mohamed A Esmaeel, M.D, Sohag Univesity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-07-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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