Clinical trial NCT04813731: COVID-19 and Lingering Symptoms in Primary Care Patients
Official title: COVID-19 and Lingering Symptoms in Primary Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Symptoms and Signs
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: Research Unit for General Practice in Aalborg
name: Utrecht University
name: National University of Ireland, Galway, Ireland
name: Region JÃ¶nkÃ¶ping County
First posted: 2021-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients over all age categories with laboratory confirmed SARS-CoV-2 infection and symptoms consistent with COVID-19

Brief summary: The ongoing corona virus disease 2019 (COVID-19) is a viral acute respiratory tract infection caused by server acute respiratory syndrom coronavirus typ 2 (SARS-CoV-2). The signs and symptom of SARS-CoV-2 infection vary and most people with COVID-19 experience illness of mild or moderate severity and recover with symptomatic treatment outside of hospital. Studies have found that some people experience lingering/long-lasting symptoms and only a minority of patients were completely free from COVID-19 related symptoms after two months. About one third still had up to two residual symptoms and 55% had three or more. As far as we know no study on lingering symptoms has been published in patients after a mild or moderate infection managed in primary care settings. The aim of this study is to explore the course of disease over a one year period and describe lingering symptoms and their impact on well-being and daily activities in adult non-hospitalized patients with previous established COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

* Confirmed SARS-CoV-2 infection, either by polymeras chain reaction (PCR), or by antigen testing (if authorized/recommended/used by national/local governments)
* Symptoms consistent with mild to moderate COVID-19
* Maximum of 2 weeks since positive SARS-CoV-2 test
* Aged 18 years and older
* Patient able and willing to comply with monthly phone calls.

Exclusion Criteria:

* Hospitalisation due to COVID-19

Primary outcomes:
measure: Time to full recovery symptoms
timeFrame: through study completion, a maximum of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Centre for General Practice, Department of Family Medicine & Population Health (FAMPOP), Faculty of Medicine and Health Sciences, University of Antwerp
city: Leuven
country: Belgium
facility: the Academic Centre for General Practice (ACHG), Department of Public Health and Primary Care, KU Leuven
city: Aalborg
country: Denmark
facility: Center for General Practice at Aalborg University
city: Nice
country: France
facility: Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France
city: Tbilisi
country: Georgia
facility: R. Lugar Center for Public Health Research
city: Würzburg
country: Germany
facility: Institut für Allgemeinmedizin Universitätsklinikum Würzburg Josef-Schneider-Str. 2/D7 97080 Würzburg
city: Galway
country: Ireland
facility: School of Medicine, National University of Ireland
city: Modena
country: Italy
facility: Covid-19 primary care special unit Sassuolo, Azienda Unità Sanitaria locale di Modena, Modena, Italy
city: Utrecht
country: Netherlands
facility: Julius Center, University Medical Center Utrecht
city: Łódź
country: Poland
facility: Medical University of Lodz, Lodz
city: Cluj Napoca
country: Romania
facility: Balan Medfam SRL
city: Jönköping
country: Sweden
facility: Wetterhälsan Primary Health Care Centre
city: Linköping
country: Sweden
facility: Kärna Primary Health Care Centre
Study officials:
affiliation: Region Jönköping County Sweden
name: Katarina Hedin, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: