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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04813731
Ethics application status
Date submitted
7/03/2021
Date registered
24/03/2021

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
Completed
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
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
300
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
Government body
Name
Katarina Hedin
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Research Unit for General Practice in 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
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Region Jönköping County
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04813731