NCT04507230

Brief Summary

Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (DIC) compared to 0.6% of survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

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

First Submitted

Initial submission to the registry

August 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

August 7, 2020

Last Update Submit

March 10, 2021

Conditions

Coagulopathy

Keywords

hypercoagulableCOVID-19

Outcome Measures

Primary Outcomes (3)

  • Coagulation screen

    Full coagulation screen

    1 month

  • Thrombophilia screen

    Full thrombophilia screen

    1 month

  • VWF, FVIII

    VWFAg, FVIII

    1 month

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COVID 19 positive by RT- PCR who are admitted to Assiut University hospitals, Egypt. Age and sex matched controls

You may qualify if:

  • patients with COVID 19 positive by RT- PCR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Hemostatic DisordersThrombophiliaCOVID-19

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of clinical pathology

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

August 7, 2020

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

EG(1)