SARS-CoV-2 immune response in asymptomatic patients

Completed

Conditions: COVID-19
SARS-CoV-2
10047438

Registration Number: NL-OMON50161

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

- Adult (age * 18 years)
- Screened for COVID-19 according to the national guidelines because of a
planned surgical or interventional procedure under general anesthesia.
- Tested positive for SARS-CoV-2 with RT-PCR.
- Asymptomatic at the moment of screening: no suspicion for COVID-19 for at
least 48 hours prior to screening, based on a standardized questionnaire
containing the following complaints: cough, dyspnoea, fever, general malaise,
myalgia, headache, extreme fatigue (new onset), throat ache, obstructed/runny
nose, loss of smell, loss of taste, abdominal pain, diarrhoea and vomiting.

Exclusion Criteria

Not able or willing to give informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Levels of serum antibody response to SARS-CoV-2 and phenotypic and functional<br /><br>characterisation of SARS-CoV-2-specific T cells.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Neutralisation potency, reactivity against different SARS-CoV-2 and other<br /><br>coronavirus proteins and the effector functions of these antibodies<br /><br>(antibody-dependent cellular cytotoxicity and phagocytosis and complement<br /><br>activation).<br /><br>- IgA antibody levels in saliva.<br /><br>- Comparison of antibody and B/T-cell response to SARS-CoV-2 in<br /><br>post-symptomatic patients (patients who had symptoms in the two weeks before<br /><br>positive screening), truly asymptomatic patients, pre-symptomatic patients<br /><br>(patients who developed symptoms in the two weeks after positive screening),<br /><br>versus those of mild and severe symptomatic patients (METC study 2020_154 and<br /><br>RECoVERED study, ZonMw funded).<br /><br>- Effect of age, comorbidity and RT-PCR cycling threshold values (of the<br /><br>screening PCR).<br /><br>- Development of SARS-COV-2 antibody levels and B/T-cell responses over time<br /><br>(up to one year after positive testing).</p><br>