NCT04479280

Brief Summary

Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world . 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 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 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

July 19, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

27 days

First QC Date

July 19, 2020

Last Update Submit

September 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • clot rate formation

    measuring how rapid the sample will get clotted

    30 minutes

Study Arms (2)

Covid19 positive patients

Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA

Covid19 negative patients

Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA

Interventions

studying coagulation disorders in COVID19 critically ill patients

Covid19 negative patientsCovid19 positive patients

Eligibility Criteria

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

patients who are suspected to be COVID 19 infection

You may qualify if:

  • COVID 19 critically ill patients

You may not qualify if:

  • any critical illness not related to COVID 19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of clinical pathology

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 21, 2020

Study Start

July 20, 2020

Primary Completion

August 16, 2020

Study Completion

August 16, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations