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Clinical Trials/NCT06695377
NCT06695377CompletedNot Applicable

Thromboembolic Complications Post-COVID-19: What is the Risk in Mild-Moderate Cases?

Marmara University Pendik Training and Research Hospital1 site in 1 country961 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
961
Locations
1
Primary Endpoint
The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Marmara University Pendik Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Buğu Usanma Koban

MD, PhD

Marmara University Pendik Training and Research Hospital

Study Sites (1)

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