No registrations found.
ID
Source
Brief title
Health condition
acute respiratory tract infection
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of COVID-19 in patients presenting with CA-ARTI in primary care
Secondary outcome
1) The clinical presentation and management of patients with CA-ARTI by their GP in primary care during the COVID-19 pandemic and insight in differences in these aspects between European countries
2) Risk factors for acquiring COVID-19
3) Risk factors of an adverse outcome in patients with COVID-19 in primary care
4) Self-management of patients with CA-ARTI during COVID-19 pandemic and insight in differences in these aspects between European countries
Background summary
Rationale: When a new infection emerges, most detailed information about presentation, management and clinical course is obtained from severe and/or hospitalized cases. This is currently also the case for the COVID-19 pandemic. As a consequence, little information is available from patients with mild and/or undiagnosed SARS-CoV-2 infection. These patients often contact primary care providers, either at the practice or by telephone. There is still much uncertainty about who will develop mild or more severe symptoms upon acquiring the infection and who is at risk of severe complications. We will therefore perform a study in primary care with patients presenting with acute respiratory tract infection in 4-8 European countries.
Objective: To generate information on the presentation and management of patients with community-acquired acute respiratory tract infection in primary care during the COVID-19 pandemic, to determine the proportion of these patients infected with SARS-CoV-2, and risk factors for getting COVID-19 and for a complicated course of COVID-19 disease.
Study design: Observational study with patient follow-up.
Study population: Patients aged one year and older, presenting in primary care (either in person, or phone/video), with symptoms of community-acquired acute respiratory tract infection (CA-ARTI) during the COVID-19 pandemic.
Main study parameters/endpoints: The proportion of patients with SARS-CoV-2 infection in patients presenting with CA-ARTI in primary care settings in various European countries, with description of their course of disease (illness days, non-productive days, complications and death).
Study objective
determination course of disease of COVID-19 in the primary care setting
Study design
follow-up at day 7 and 28
Intervention
none
Alike van der Velden
31 88-756 8511
a.w.vandervelden@umcutrecht.nl
Alike van der Velden
31 88-756 8511
a.w.vandervelden@umcutrecht.nl
Inclusion criteria
• Male or female aged one year or older;
• Consulting face-to-face, online, or telephoning with symptoms of CA-ARTI (upper and or lower), with symptoms of cough, sore throat and/or rhinitis, or when the GP has another reason to suspect COVID-19;
• Is able and willing to comply with all study requirements;
• Participant or legal guardian(s) of a child is able and willing to give informed consent;
• Availability of a freezer at the practice, patient’s home, or a laboratory location to be reached within 1 hour.
Exclusion criteria
• Patients with symptoms of earache only;
• Patients who do not master the national language or are otherwise not able to participate in follow-up procedures;
• Patients who are terminally ill;
• Patients tested positive for SARS-CoV-2 prior to recruitment.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8520 |
| CCMO | NL73596.041.20 |