NCT05018052

Brief Summary

Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection. Patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may lead to chronic fatigue syndrome and as well as many other complications. The vast majority of COVID-19 patients remaining in isolation/quarantine, due to the mild course of the disease, do not require hospitalization. In this group of patients, the course of COVID-19 is very different - from asymptomatic patients to very severe and long lasting symptoms also with a decrease in saturation. There are many studies describing the course and complications of patients hospitalized due to COVID-19. There is little published data on how non-hospitalized patients get sick and what are the early and late complications of SARS-CoV-2 infection. In addition, many patients remain ill even many months after COVID-19, entering what is known as LONG-COVID. Therefore, the STOP-COVID Registry was established. The purpose of the Registry is to assess the course of COVID-19 infection, early and late cardiovascular complications of COVID-19 in patients with and without hospitalization. In addition, the purpose of the STOP-COVID Registry is to assess the incidence of LONG-COVID with all other complications and to identify predictive factors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 29, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

August 23, 2021

Last Update Submit

August 23, 2021

Conditions

Keywords

Covid19Covid complicationsLong-CovidChronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (3)

  • Early and Late COVID-19 cardio-vascular complications

    Early and Late COVID-19 cardio-vascular complications

    5 years

  • Predictors of Long-Covid Cardio-Vascular complications

    Predictors of Long-Covid Cardio-Vascular complications

    5 years

  • SCORE - algorithm to help to predict the highest risk of Long-Covid complications

    SCORE - algorithm to help to predict the highest risk of Long-Covid complications

    5 years

Secondary Outcomes (3)

  • Detailed patients' characteristics and differences in those with and without Long-Covid complications

    5 years

  • Definition and characteristics of the early and Late COVID-19 complications

    5 years

  • Comparison of complications and Long-Covid depending on the severity of the course of COVID-19 COVID-19, comorbidities

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years and older diagnosed with COVID-19, after full recovery (resolution of clinical symptoms, minimum 14 days after last symptoms), with and without hospitalization .

You may qualify if:

  • Patients after COVID-19, 18 years and older

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center, Saint Family Hospital

Lodz, 90-302, Poland

Location

Related Publications (2)

  • Babicki M, Kapusta J, Kolat D, Kaluzinska-Kolat Z, Mastalerz-Migas A, Jankowski P, Chudzik M. Cardiac symptoms in patients 3-6 months after contracting COVID-19- data from the polish STOP-COVID registry. BMC Infect Dis. 2025 Apr 9;25(1):489. doi: 10.1186/s12879-025-10774-0.

  • Kapusta J, Chudzik M, Kaluzinska-Kolat Z, Kolat D, Burzynska M, Jankowski P, Babicki M. Do selected lifestyle parameters affect the severity and symptoms of COVID-19 among elderly patients? The retrospective evaluation of individuals from the STOP-COVID registry of the PoLoCOV study. J Infect Public Health. 2023 Jan;16(1):143-153. doi: 10.1016/j.jiph.2022.12.008. Epub 2022 Dec 12.

Related Links

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 SyndromeFatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor, Cardiologist, Medical Director Ambulatory Clinic

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 24, 2021

Study Start

May 29, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations