COVID-19 And Lingering Symptoms In Primary Care Patients

NCT04813731 | Completed

• 1 other identifier: 2020-05448
• Study Type: observational
• Target: 300
• Locations: 11 countries
• Sites: 13

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.

Conditions

Covid19; Symptoms and Signs

Outcome Measures

Primary Outcomes (1)

• Time to full recovery symptoms

  Number of weeks until "back to normal"

  through study completion, a maximum of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Hospitalisation due to COVID-19

Sponsors & Collaborators

• Katarina Hedin: lead
• Research Unit for General Practice in Aalborg: collaborator
• Utrecht University: collaborator
• National University of Ireland, Galway, Ireland: collaborator
• Region Jönköping County: collaborator

Study Sites (13)

Centre for General Practice, Department of Family Medicine & Population Health (FAMPOP), Faculty of Medicine and Health Sciences, University of Antwerp

Antwerp, Belgium

Location

the Academic Centre for General Practice (ACHG), Department of Public Health and Primary Care, KU Leuven

Leuven, Belgium

Location

Center for General Practice at Aalborg University

Aalborg, Denmark

Location

Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France

Nice, France

Location

R. Lugar Center for Public Health Research

Tbilisi, Georgia

Location

Institut für Allgemeinmedizin Universitätsklinikum Würzburg Josef-Schneider-Str. 2/D7 97080 Würzburg

Würzburg, Germany

Location

School of Medicine, National University of Ireland

Galway, Ireland

Location

Covid-19 primary care special unit Sassuolo, Azienda Unità Sanitaria locale di Modena, Modena, Italy

Modena, Italy

Location

Julius Center, University Medical Center Utrecht

Utrecht, Netherlands

Location

Medical University of Lodz, Lodz

Lodz, Poland

Location

Balan Medfam SRL

Cluj-Napoca, Romania

Location

Wetterhälsan Primary Health Care Centre

Jönköping, Sweden

Location

Kärna Primary Health Care Centre

Linköping, Sweden

Location

MeSH Terms

Conditions

COVID-19; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms

Study Officials

• Katarina Hedin, Assoc Prof

  Region Jönköping County Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 24, 2021
• Study Start: December 12, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); SE (2); DE (1); IE (1); DK (1); NL (1); IT (1); RO (1); FR (1); BE (2); GE (1)