ong-term consequences of more severe COVID-19 infections (complicated respiratory tract infections), in patients managed in general practice and risk factors for a delayed recovery

Completed

Conditions: respiratory tract infection covid-19
10047438
10024970

Registration Number: NL-OMON52826

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 322

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- At least 18 years of age
- History of a complicated respiratory tract infection (ICPC code R81 pneumonia
or R02 dyspnea, R05 cough, R74 respiratory tract infection R83 other
respiratory tract infection or R78 bronchitis for which a course of antibiotics
was started), between March 1st and June 1st 2020 in primary care

In order to be eligible to participate in the substudy on neuCD10 expression, a
subject must meet all the following criteria:
- Positive SARS-CoV-2 study-serology
- Written consent to be approached for additional research

Exclusion Criteria

- Life expectancy of <1 year,
- Hospitalisation in the previous 14 days before the index consultation
- Not capable of performing telephone interviews
- Hospitalisation within 14 days after the index consultation

A potential subject who meets any of the following criteria will be excluded
from participation in the substudy on neuCD10 expression:
- Death during follow-up

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in the health-related quality of<br /><br>life (determined by SF-36) between patients with and without an established<br /><br>SARS-CoV-2 infection in a 12 month follow-up period and risk factors that<br /><br>influence recovery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundairy objectives are to assess in patients who were suspected of having<br /><br>serious COVID-19 infections: differences in the different sections of the<br /><br>SF-36 from index consultation to 12 months after the index consultation, the<br /><br>severity and duration of physical complaints and risk factors that influence<br /><br>recovery, the number of episodes of respiratory infections requiring antibiotic<br /><br>prescription, exacerbations of chronic disorders, hospital referrals, mortality<br /><br>within 12 months, number of contacts with GP, the extent of mental complaints<br /><br>or mental disorders and impact on daily activities.<br /><br>Objectives of the substudy are to assess the presence and severity of<br /><br>long-lasting physical and psychological symptoms after COVID-19 and NeuCD10<br /><br>expression in blood samples of subjects (using flow cytometry) 24-29 months<br /><br>after a confirmed COVID-19 infection.</p><br>