Clinical trial NCT06695377: Thromboembolic Complications in Mild Covid-19 Cases
Official title: Thromboembolic Complications Post-COVID-19: What is the Risk in Mild-Moderate Cases?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Thromboembolic and Bleeding Complications
Thromboembolism, Venous
Post COVID-19
Keywords: COVID 19
thromboembolism
thromboembolic complications
pulmonary embolism
deep venous thrombosis
Lead sponsor: Marmara University Pendik Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 961
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization.
timeFrame: january-june 2022
measure: The relationship between patients' comorbidities and the occurrence of thromboembolic events post-COVID.
timeFrame: january-june 2022
measure: The relationship between patients' medications and the occurrence of thromboembolic events post-COVID.
timeFrame: january-june 2022
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University Medical School
Study officials:
affiliation: Marmara University Medical Faculty
name: Buğu Usanma Koban
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.