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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04405232
Other study ID # 20SM5934
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 25, 2020
Est. completion date June 25, 2021

Study information

Verified date July 2020
Source Imperial College London
Contact Dr Deepa Jayakody Arachchillage, MRCP, FRCPath, MD
Phone 02073518401
Email d.arachchillage@imperial.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date June 25, 2021
Est. primary completion date April 25, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-interventional
Observational study

Locations

Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary Incidence of respiratory failure requiring CPAP or mechanical ventilation 12 months
Secondary 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 12 months
Secondary Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality 12 months
Secondary Incidence of clinically relevant non-major bleeding 12 months
Secondary Incidence of Heparin induced thrombocytopenia 12 months
Secondary Incidence of Acute coronary syndrome 12 months
Secondary Incidence of renal failure requiring renal replacement therapy 12 months
Secondary Incidence of Multiorgan failure 12 months
Secondary Incidence of Development of DIC 12 months
Secondary Duration of hospital stay (days) 12 months
Secondary Hospital mortality 12 months
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