COVID 19NCT06695377
Thromboembolic Complications in Mild Covid-19 Cases
An observational study of COVID 19 and Thromboembolic and Bleeding Complications, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID 19, Thromboembolic and Bleeding Complications, Thromboembolism, Venous
- How many people
- 961 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID 19, Thromboembolic and Bleeding Complications, Thromboembolism, Venous, Post COVID-19
- Keywords
- COVID 19, thromboembolism, thromboembolic complications, pulmonary embolism, deep venous thrombosis
- Medical subject headings
- COVID-19, Venous Thromboembolism, Thromboembolism, Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a PCR-confirmed COVID-19 diagnosis who were followed up on an outpatient basis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization.
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.
Measured: january-june 2022
The relationship between patients' comorbidities and the occurrence of thromboembolic events post-COVID.
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.
Measured: january-june 2022
The relationship between patients' medications and the occurrence of thromboembolic events post-COVID.
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.
Measured: january-june 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 961 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buğu Usanma Koban, Marmara University Pendik Training and Research Hospital
- Investigators
- Buğu Usanma Koban, Principal investigator, Marmara University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695377
- Sponsor's protocol ID
- 02.12.2022.1652
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data may be shared anonymously with researchers if needed.
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.
PubMed 37029943Katsoularis 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.
PubMed 35387772Usanma Koban B, Celik O, Sur Unal U, Uzuner A. Assessing the Burden of Thromboembolic Complications in Outpatient COVID-19 Cases: A Focused Study on Patients Followed in Primary Care. Can J Infect Dis Med Microbiol. 2025 Jul 24;2025:7242450. doi: 10.1155/cjid/7242450. eCollection 2025.
PubMed 40747374
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboembolic Complications Post-COVID-19: What is the Risk in Mild-Moderate Cases?
- ClinicalTrials.gov ID
- NCT06695377
- Acronym / sponsor ID
- 02.12.2022.1652
- Conditions
- COVID 19, Thromboembolic and Bleeding Complications, Thromboembolism, Venous, Post COVID-19
- Keywords
- COVID 19, thromboembolism, thromboembolic complications, pulmonary embolism, deep venous thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 961 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Nov 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a PCR-confirmed COVID-19 diagnosis who were followed up on an outpatient basis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization.
Time frame: january-june 2022
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.
The relationship between patients' comorbidities and the occurrence of thromboembolic events post-COVID.
Time frame: january-june 2022
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.
The relationship between patients' medications and the occurrence of thromboembolic events post-COVID.
Time frame: january-june 2022
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 37029943Azevedo-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.
- Background: PubMed 35387772Katsoularis 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.
- Derived from this study: PubMed 40747374Usanma Koban B, Celik O, Sur Unal U, Uzuner A. Assessing the Burden of Thromboembolic Complications in Outpatient COVID-19 Cases: A Focused Study on Patients Followed in Primary Care. Can J Infect Dis Med Microbiol. 2025 Jul 24;2025:7242450. doi: 10.1155/cjid/7242450. eCollection 2025.
- Individual participant dataSharing planned: No. The research data may be shared anonymously with researchers if needed.
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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.
Buğu Usanma Koban principal investigator
Marmara University Medical Faculty
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 and Thromboembolic and Bleeding Complications, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 19 Nov 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization. (time frame: january-june 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695377, which also lists 3 linked publications.
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 19 Nov 2024.