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

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

      • İstanbul, Turkey
        • Marmara University Medical School

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
Patients with a PCR-confirmed COVID-19 diagnosis who were followed up on an outpatient basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
january-june 2022
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.
january-june 2022
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.
january-june 2022

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.

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

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.

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