COVID-19NCT05068375
Unleash the Mystery of COVID-19 Related Unusual Thrombosis
An observational study of COVID-19, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Thrombophilia screening
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 15 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
, Faculty of Medicine, Sohag University
Sohag, 82524
Mahmoud I. Elbadry, MD, PhD, +01065964083, mahmoudibrahim@med.sohag.edu.eg
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Thrombophilia screening
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombophilia screeningDiagnostic test
Genetic thrombophilia and acquired thrombophilia screening
| Study group | Role | What they receive |
|---|---|---|
| Thrombotic group | Non-critically COVID-19 patients with unusual thrombotic events Receives: Diagnostic Test: Thrombophilia screening | |
| Non-thrombotic group | Non-critically COVID-19 patients without thrombotic events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency
Rates of unusual thrombotic events among non-critically ill young adults' patients with COVID-19
Measured: 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.
Measured: First month after diagnosis
Bleeding complications of the UTEs
Bleeding (major, minor bleedings)
- 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.
Measured: First month after diagnosis
Mortality
Death frequency
Measured: First month after diagnosis
Secondary outcomes (3)
Thrombosis recurrence
Incidence of thrombosis recurrence after the initial thrombotic event(s)
Measured: During 6 months of follow up period
Bleeding
Incidence of bleeding (major, minor bleedings)
Measured: During 6 months of follow up period
Mortality
Death frequency
Measured: During 6 months of follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Apr 2020
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ibrahim Yousef, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068375
- Sponsor's protocol ID
- Soh-Med-21-04-39
- Status last verified
- May 2022
- First submitted
- 2 Oct 2021
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05068375
- Acronym / sponsor ID
- Soh-Med-21-04-39
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombotic group | – | Diagnostic Test: Thrombophilia screeningNon-critically COVID-19 patients with unusual thrombotic events |
| Non-thrombotic group | – | –Non-critically COVID-19 patients without thrombotic events |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombophilia screeningGenetic thrombophilia and acquired thrombophilia screening | Diagnostic test | Thrombotic group |
Primary outcome
Frequency
Time frame: Form April 2020 to April 2021
Rates of unusual thrombotic events among non-critically ill young adults' patients with COVID-19
Thrombosis progression
Time frame: First month after diagnosis
Thrombosis progression: Symptomatic extension of a pre-existing thrombus or new symptomatic thrombus not evident on the initial imaging at a second compressive examination.
Bleeding complications of the UTEs
Time frame: First month after diagnosis
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.
Mortality
Time frame: First month after diagnosis
Death frequency
3 secondary outcomes
Thrombosis recurrence
Time frame: During 6 months of follow up period
Bleeding
Time frame: During 6 months of follow up period
Mortality
Time frame: During 6 months of follow up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency (time frame: Form April 2020 to April 2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.