Clinical trial NCT04405232: Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK
Official title: Coagulopathy Associated With Coronavirus disease19 (CA-COVID19) A Multi-Centre Observational Study in UK
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Thrombosis
Bleeding
Anticoagulation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\>18 years) admitted hospitals with suspected COVID-19 infection

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of respiratory failure requiring CPAP or mechanical ventilation
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality
timeFrame: 12 months
measure: Incidence of clinically relevant non-major bleeding
timeFrame: 12 months
measure: Incidence of Heparin induced thrombocytopenia
timeFrame: 12 months
measure: Incidence of Acute coronary syndrome
timeFrame: 12 months
measure: Incidence of renal failure requiring renal replacement therapy
timeFrame: 12 months
measure: Incidence of Multiorgan failure
timeFrame: 12 months
measure: Incidence of Development of DIC
timeFrame: 12 months
measure: Duration of hospital stay (days)
timeFrame: 12 months
measure: Hospital mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Dr Deepa Jayakody Arachchillage, FRCPath, MD
role: STUDY_CHAIR
References: