COVID-19 And Lingering Symptoms In Primary Care Patients

Covid19 Clinical Trial

— CALIP  

Official title:

COVID-19 And Lingering Symptoms In Primary Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813731
• Other study ID #: 2020-05448
• Status: Recruiting
• Start date: December 12, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Region Jönköping County
• Contact: Katarina Hedin, Ass prof
• Phone: +46761303619
• Email: katarina.hedin[@]rjl.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Symptoms and Signs

Locations

Country	Name	City	State
Belgium	Centre for General Practice, Department of Family Medicine & Population Health (FAMPOP), Faculty of Medicine and Health Sciences, University of Antwerp	Antwerp
Belgium	the Academic Centre for General Practice (ACHG), Department of Public Health and Primary Care, KU Leuven	Leuven
Denmark	Center for General Practice at Aalborg University	Aalborg
France	Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France	Nice
Georgia	R. Lugar Center for Public Health Research	Tbilisi
Germany	Institut für Allgemeinmedizin Universitätsklinikum Würzburg Josef-Schneider-Str. 2/D7 97080 Würzburg	Würzburg
Ireland	School of Medicine, National University of Ireland	Galway
Italy	Covid-19 primary care special unit Sassuolo, Azienda Unità Sanitaria locale di Modena, Modena, Italy	Modena
Netherlands	Julius Center, University Medical Center Utrecht	Utrecht
Poland	Medical University of Lodz, Lodz	Lódz
Romania	Balan Medfam SRL	Cluj Napoca
Sweden	Wetterhälsan Primary Health Care Centre	Jönköping
Sweden	Kärna Primary Health Care Centre	Linköping

Sponsors (4)

Lead Sponsor	Collaborator
Katarina Hedin	National University of Ireland, Galway, Ireland, Research Unit of General Practice, Aalborg, Utrecht University

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Georgia,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Romania,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to full recovery symptoms	Number of weeks until "back to normal"	through study completion, a maximum of 1 year