- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06695377
Thromboembolic Complications in Mild Covid-19 Cases
November 17, 2024 updated by: Buğu Usanma Koban, Marmara University Pendik Training and Research Hospital
Thromboembolic Complications Post-COVID-19: What is the Risk in Mild-Moderate Cases?
The aim of the study is to investigate the frequency of thromboembolic complications and the factors influencing them in COVID-19 cases that did not require hospitalization.
For this purpose, patients registered at two different family health centers in Istanbul were retrospectively screened, and their status regarding post-COVID-19 thromboembolic events was recorded.
The sociodemographic characteristics, medical history, COVID-19 treatments received, comorbidities, and current medications of all patients were examined and compared with the occurrence of complications.
Study Overview
Status
Completed
Detailed Description
Studies on COVID-19 complications in the literature have predominantly focused on patients treated in hospitals, particularly in intensive care units.
Data on patients with mild to moderate symptoms who were followed up on an outpatient basis in primary care are quite limited.
Therefore, our research investigated the incidence of thrombotic events within six months following infection in mild to moderate COVID-19 cases and the factors that might influence these events.
Records of 961 individuals registered at two different family health centers in Istanbul were reviewed.
Patients were contacted by phone, informed about the study, and data regarding their sociodemographic characteristics, medical histories, COVID-19 infection experiences, and medications used were collected.
Comparative analyses (Fisher's exact test) and logistic regression tests were conducted.
Study Type
Observational
Enrollment (Actual)
961
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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İstanbul, Turkey
- Marmara University Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients over the age of 18 who were registered at family health centers in two different districts of Istanbul and had a confirmed COVID-19 infection verified by PCR test between January 1, 2022, and June 30, 2022, were included in the study.
Description
Inclusion Criteria:
- Being over 18 years of age
- Having had a confirmed COVID-19 infection verified by a PCR test
- Being monitored at a family health center without requiring hospitalization during the COVID-19 course
- Having at least 6 months elapsed since the infection
- Availability of the patient's medical records
- Absence of any language barrier or health issue that would prevent communication with the patient
Exclusion Criteria:
- Being under 18 years of age
- Having had less than 6 months since the COVID-19 infection
- Presence of any condition that prevents communication with the patient
- Incomplete or missing medical records of the patient
- History of hospitalization due to COVID-19 infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with a PCR-confirmed COVID-19 diagnosis who were followed up on an outpatient basis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization.
Time Frame: january-june 2022
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Patients registered at a family health center were retrospectively reviewed, and those with a history of COVID-19 PCR positivity who had been followed up as outpatients were included.
The occurrence of venous or arterial thromboembolism within the first 6 months after infection was recorded from their medical reports, and the frequency was calculated.
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january-june 2022
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The relationship between patients' comorbidities and the occurrence of thromboembolic events post-COVID.
Time Frame: january-june 2022
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The patients' existing chronic conditions from the time of their COVID-19 infection were recorded by reviewing the family medicine system.
The presence of chronic diseases was then analyzed in comparison to the occurrence of thrombosis within the first 6 months following COVID-19 infection.
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january-june 2022
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The relationship between patients' medications and the occurrence of thromboembolic events post-COVID.
Time Frame: january-june 2022
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The medications regularly used by patients for their chronic conditions since the time of their COVID-19 infection were noted by reviewing records in the family medicine system.
These medications were then analyzed in comparison to the occurrence of thrombosis within the first 6 months following COVID-19 infection.
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january-june 2022
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Buğu Usanma Koban, Marmara University Medical Faculty
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Azevedo-Cerqueira A, Torrao Pinheiro P, Oliveira J, Manuel-Marques M, Rocha Neves J. Risk Of Venous Thrombosis In The Primary Care Setting During The Covid-19 Pandemic. Port J Card Thorac Vasc Surg. 2023 Apr 4;30(1):43-47. doi: 10.48729/pjctvs.310.
- Katsoularis I, Fonseca-Rodriguez O, Farrington P, Jerndal H, Lundevaller EH, Sund M, Lindmark K, Fors Connolly AM. Risks of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19: nationwide self-controlled cases series and matched cohort study. BMJ. 2022 Apr 6;377:e069590. doi: 10.1136/bmj-2021-069590.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
November 13, 2024
First Submitted That Met QC Criteria
November 17, 2024
First Posted (Estimated)
November 19, 2024
Study Record Updates
Last Update Posted (Estimated)
November 19, 2024
Last Update Submitted That Met QC Criteria
November 17, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Thromboembolism
- Venous Thromboembolism
Other Study ID Numbers
- 02.12.2022.1652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The research data may be shared anonymously with researchers if needed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.