NCT04982263

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 26, 2021

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Agreement of abnormalities in coagulation profile with measured inflammatory markers

    baseline measurement of inflammatory markers

Study Arms (2)

Mild cases

Patients with confirmed COVID-19 and with mild disease

Diagnostic Test: Blood coagulation profile

Severe cases

Patients with confirmed COVID-19 and with severe disease

Diagnostic Test: Blood coagulation profile

Interventions

Venous blood sample for measurement of blood coagulation profile

Mild casesSevere cases

Eligibility Criteria

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

Cases with confirmed COVID 19 disease

You may qualify if:

  • ● Confirmed cases with COVID 19

You may not qualify if:

  • ● Known history of blood coagulopathy disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sohag University

Sohag, 82425, Egypt

Location

Sohag University

Sohag, 82524, Egypt

Location

Related 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. No abstract available.

    PMID: 32109011BACKGROUND
  • 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.

    PMID: 32073213BACKGROUND
  • 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.

    PMID: 32282949BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hend mohamed A Esmaeel, M.D

    Sohag Univesity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 26, 2021

First Posted

July 29, 2021

Study Start

February 1, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations