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NCT04982263 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04982263
Other study ID # Soh-Med-21-07-34
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date May 31, 2021

Study information
Verified date July 2021
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: ? Confirmed cases with COVID 19 Exclusion Criteria: ? Known history of blood coagulopathy disorder

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood coagulation profile
Venous blood sample for measurement of blood coagulation profile

Locations
Country Name City State
Egypt Sohag University Sohag
Egypt Sohag University Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. — View Citation

Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13. — View Citation

Terpos E, Ntanasis-Stathopoulos I, Elalamy I, Kastritis E, Sergentanis TN, Politou M, Psaltopoulou T, Gerotziafas G, Dimopoulos MA. Hematological findings and complications of COVID-19. Am J Hematol. 2020 Jul;95(7):834-847. doi: 10.1002/ajh.25829. Epub 2020 May 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary correlation of disease severity with results of laboratory test 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 Agreement of abnormalities in coagulation profile with measured inflammatory markers The inflammatory markers will be measured and correlation with abnormalities in coagulation profile will be assessed baseline measurement of inflammatory markers
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