Unleash the Mystery of COVID-19 Related Unusual Thrombosis

NCT05068375 | Unknown

• 1 other identifier: Soh-Med-21-04-39
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Thrombosis recurrence

  During 6 months of follow up period

• Bleeding

  During 6 months of follow up period

• Mortality

  During 6 months of follow up period

Study Arms (2)

Thrombotic group

Non-critically COVID-19 patients with unusual thrombotic events

Diagnostic Test: Thrombophilia screening

Non-thrombotic group

Non-critically COVID-19 patients without thrombotic events

Interventions

Thrombophilia screening DIAGNOSTIC_TEST

Genetic thrombophilia and acquired thrombophilia screening

Thrombotic group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

, Faculty of Medicine, Sohag University

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor MD Phd.

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 5, 2021
• Study Start: April 1, 2020
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)