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

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ClinicalTrials.gov Identifier: NCT04405232
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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.

Condition or disease Intervention/treatment
COVID Thrombosis Bleeding Anticoagulation Other: Non-interventional

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coagulopathy Associated With Coronavirus disease19 (CA-COVID19) A Multi-Centre Observational Study in UK
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : April 25, 2021
Estimated Study Completion Date : June 25, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Non-interventional
    Observational study


Primary Outcome Measures :
  1. Prevalence and characteristics of coagulation abnormalities and their predictive value for respiratory failure requiring ventilation, multiorgan failure and death in patients presenting with COVID 19 infection [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Incidence of respiratory failure requiring CPAP or mechanical ventilation [ Time Frame: 12 months ]
  2. Incidence of thrombosis (clinical or radiological diagnosis) including thrombosis within 90 days after hospital admission (hospital associated thrombosis) 4. Incidence of minor bleeding 5. Heparin induced thrombocytopenia 6. Acute coronary syndrome [ Time Frame: 12 months ]
  3. Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality [ Time Frame: 12 months ]
  4. Incidence of clinically relevant non-major bleeding [ Time Frame: 12 months ]
  5. Incidence of Heparin induced thrombocytopenia [ Time Frame: 12 months ]
  6. Incidence of Acute coronary syndrome [ Time Frame: 12 months ]
  7. Incidence of renal failure requiring renal replacement therapy [ Time Frame: 12 months ]
  8. Incidence of Multiorgan failure [ Time Frame: 12 months ]
  9. Incidence of Development of DIC [ Time Frame: 12 months ]
  10. Duration of hospital stay (days) [ Time Frame: 12 months ]
  11. Hospital mortality [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (>18 years) admitted hospitals with suspected COVID-19 infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405232


Contacts
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Contact: Dr Deepa Jayakody Arachchillage, MRCP, FRCPath, MD 02073518401 d.arachchillage@imperial.ac.uk

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
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Study Chair: Dr Deepa Jayakody Arachchillage, FRCPath, MD Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04405232    
Other Study ID Numbers: 20SM5934
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases