NCT06695377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
961

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 13, 2024

Last Update Submit

November 17, 2024

Conditions

Keywords

COVID 19thromboembolismthromboembolic complicationspulmonary embolismdeep venous thrombosis

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    january-june 2022

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Medical School

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 37029943BACKGROUND
  • 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.

    PMID: 35387772BACKGROUND
  • Usanma 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.

MeSH Terms

Conditions

COVID-19Venous ThromboembolismThromboembolismPulmonary EmbolismVenous Thrombosis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesEmbolismThrombosis

Study Officials

  • Buğu Usanma Koban

    Marmara University Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 19, 2024

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

The research data may be shared anonymously with researchers if needed.

Locations