Unleash the Mystery of COVID-19 Related Unusual Thrombosis

COVID-19 Clinical Trial

Official title:

Unusual Pattern of Thrombotic Events in Young Adults Noncritically Ill Patients With COVID-19 May Result From An Un-diagnosed Inherited Form of Thrombophilia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068375
• Other study ID #: Soh-Med-21-04-39
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: October 15, 2022

Study information

• Verified date: May 2022
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Arterial thrombosis and unusual patterns of thrombotic events in young adults patients with COVID-19 are yet rarely described in this setting and could be underestimated. There is a real need for studies to describe the frequency of unusual thrombotic complications.

Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), first identified in Wuhan, China in December of 2019, has become a worldwide pandemic with widespread illness and mortality. Clinical manifestations of Coronavirus disease 2019 (COVID-19) are absent or mild in a substantial proportion of patients who test positive for COVID-19. Although respiratory compromise is the cardinal feature of the disease, early studies have suggested that elevated circulating D-dimer levels are associated with mortality suggesting a distinct coagulation disorder associated with COVID-19. COVID-19 infection is commonly complicated with pro-thrombotic state and endothelial dysfunction. Recent autopsy studies of COVID-19 patients supported this hypothesis by demonstrating the extensive extracellular fibrin deposition and presence of fibrin thrombi within distended capillaries and small vessels. Observational studies reported an excess of venous thromboembolic events (deep vein thrombosis (DVT), pulmonary embolism (PE)) among patients suffering from Covid-19. Retrospective studies have reported thrombotic rates in excess of 20% to 30%, but the use of prophylactic anticoagulation and duration of treatment were not consistent between studies. Unrecognized PE and pulmonary in situ thrombosis were reported as causes of the high mortality observed among COVID-19 patients. There is currently no clear estimation of the risk of arterial and, in particular, venous thromboembolic complications which depend on local diagnostic and pharmacological preventive strategies. In addition to D-dimer, a prolonged prothrombin time (PT) has been associated with decreased survival and increased need for critical care. However, arterial thrombosis and unusual patterns of thrombotic events in young adults patients with COVID-19 are yet rarely described in this setting and could be underestimated (9). Thus, there is a real need for studies to describe the frequency of unusual thrombotic complications. Therefore, the purpose of this study will be to explore thromboembolic risk and associated predicting factors in the young adults' cohort of noncritically ill COVID-19 patients which will help to optimize diagnostic, therapeutic, and preventive strategies of COVID-19 related thrombosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• non-critically ill young adults' patients with COVID-19 admitted to our hospital will have confirmed unusual thrombotic events and accept recruitment to this study. After that, we will focus only on previously healthy patients without pre-existing prothrombotic factors and presented with COVID-19 related unusual thrombotic events

Exclusion Criteria:

• COVID-19 patients below 18 years and above 40 years
• COVID-19 patients diagnosed as critically ill COVID-19
• COVID-19 patients with pre-existing diabetes mellitus (DM), hypertension, ischemic heart disease (IHD), valvular heart disease, cardiomyopathy and chronic arrhythmia, dyslipidemia, metabolic syndrome, chronic kidney disease, liver disease, nephrotic syndrome, previous autoimmune disease, and malignancy
• COVID-19 patients with chronic lung disease or immune compromise
• COVID-19 pregnant women
• COVID-19 patient with history of thrombosis/ psychiatric disorders/ drug abuse
• COVID-19 patient previously diagnosis with congenital thrombophilia
• COVID-19 patient with drug history could induce thrombosis.
• COVID-19 patient unwilling to be followed up.
• Patients are previously diagnosed with one or more risk factors of thrombosis

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Thrombophilia screening
Genetic thrombophilia and acquired thrombophilia screening

Locations

Country	Name	City	State
Egypt	, Faculty of Medicine, Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency	Rates of unusual thrombotic events among non-critically ill young adults' patients with COVID-19	Form April 2020 to April 2021
Primary	Thrombosis progression	Thrombosis progression: Symptomatic extension of a pre-existing thrombus or new symptomatic thrombus not evident on the initial imaging at a second compressive examination.	First month after diagnosis
Primary	Bleeding complications of the UTEs	Bleeding (major, minor bleedings); I. Major bleeding is defined as frank bleeding contributed to death or associated with a decreasing in hemoglobin =2 g/dL, or need a packed red blood cells transfusion =2 units, or bleeding at a critical site.; II. Non-major bleeding was defined as any symptom or sign of bleeding that did not fit the criteria of major bleeding but fulfilled at least one of the these criteria: leading to hospitalization, or requiring healthcare professional medical intervention, or spurring a face-to-face assessment.	First month after diagnosis
Primary	Mortality	Death frequency	First month after diagnosis
Secondary	Thrombosis recurrence	Incidence of thrombosis recurrence after the initial thrombotic event(s)	During 6 months of follow up period
Secondary	Bleeding	Incidence of bleeding (major, minor bleedings)	During 6 months of follow up period
Secondary	Mortality	Death frequency	During 6 months of follow up period