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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04813731




Registration number
NCT04813731
Ethics application status
Date submitted
7/03/2021
Date registered
24/03/2021
Date last updated
19/01/2022

Titles & IDs
Public title
COVID-19 And Lingering Symptoms In Primary Care Patients
Scientific title
COVID-19 And Lingering Symptoms In Primary Care Patients
Secondary ID [1] 0 0
2020-05448
Universal Trial Number (UTN)
Trial acronym
CALIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Symptoms and Signs 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to full recovery symptoms
Timepoint [1] 0 0
through study completion, a maximum of 1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Hospitalisation due to COVID-19

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Denmark
State/province [3] 0 0
Aalborg
Country [4] 0 0
France
State/province [4] 0 0
Nice
Country [5] 0 0
Georgia
State/province [5] 0 0
Tbilisi
Country [6] 0 0
Germany
State/province [6] 0 0
Würzburg
Country [7] 0 0
Ireland
State/province [7] 0 0
Galway
Country [8] 0 0
Italy
State/province [8] 0 0
Modena
Country [9] 0 0
Netherlands
State/province [9] 0 0
Utrecht
Country [10] 0 0
Poland
State/province [10] 0 0
Lódz
Country [11] 0 0
Romania
State/province [11] 0 0
Cluj Napoca
Country [12] 0 0
Sweden
State/province [12] 0 0
Jönköping
Country [13] 0 0
Sweden
State/province [13] 0 0
Linköping

Funding & Sponsors
Primary sponsor type
Other
Name
Katarina Hedin
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Research Unit of General Practice, Aalborg
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Utrecht University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National University of Ireland, Galway, Ireland
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04813731
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Katarina Hedin, Assoc Prof
Address 0 0
Region Jönköping County Sweden
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katarina Hedin, Ass prof
Address 0 0
Country 0 0
Phone 0 0
+46761303619
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04813731