Unleash the Mystery of COVID-19 Related Unusual Thrombosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Thrombophilia screening

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Recruiting
    • , Faculty of Medicine, Sohag University
    • Contact: Mahmoud I. Elbadry, MD, PhD; Phone Number: +01065964083; Email: mahmoudibrahim@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Study group:

At Sohag University Hospitals, we conducted a longitudinal observational study with a 6-month follow-up duration across a fourteen-month period (April 2020 to June 2021). This study enrolled young adult non-critical ill patients (age 18 to 40) with a positive SARS-CoV-2 reverse-transcriptase polymerase chain reaction (rt-PCR) test and unusual sites of thrombotic events. These patients will be compared to young adult non-critical patients presented to our hospital with COVID-19 without thrombosis during the study period.

Patients will be classified into two groups:

• Group I: COVID-19 patients with unusual thrombosis
• Group II: COVID-19 patients without unusual thrombosis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thrombotic group; Non-critically COVID-19 patients with unusual thrombotic events	Diagnostic test: Thrombophilia screening; Genetic thrombophilia and acquired thrombophilia screening
Non-thrombotic group; Non-critically COVID-19 patients without thrombotic events

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency	Rates of unusual thrombotic events among non-critically ill young adults' patients with COVID-19	Form April 2020 to April 2021
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
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
Mortality	Death frequency	First month after diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombosis recurrence	Incidence of thrombosis recurrence after the initial thrombotic event(s)	During 6 months of follow up period
Bleeding	Incidence of bleeding (major, minor bleedings)	During 6 months of follow up period
Mortality	Death frequency	During 6 months of follow up period

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Soh-Med-21-04-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No