Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK

NCT ID: NCT04405232

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-25

Study Completion Date

2021-06-25

Brief Summary

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A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure \[acute respiratory distress syndrome (ARDS)\] and death is a global threat. On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time \[PT\] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries. Eventually \>50% of people will have become infected and COVID-19 will remain a public health threat in the long term. It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients. In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.

Detailed Description

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Conditions

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COVID Thrombosis Bleeding Anticoagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional

Observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (\>18 years) admitted hospitals with COVID 19 infection (COVID RNA+ +/- radiological change +/- clinical suspicion in absence of RNA)

Exclusion Criteria

* No exclusions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Deepa Jayakody Arachchillage, FRCPath, MD

Role: STUDY_CHAIR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dr Deepa Jayakody Arachchillage, MRCP, FRCPath, MD

Role: CONTACT

Phone: 02073518401

Email: [email protected]

Other Identifiers

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20SM5934

Identifier Type: -

Identifier Source: org_study_id