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SARS-CoV-2 immune response in asymptomatic patients

SARS-CoV-2 immune response in asymptomatic patients - SCOUT-2 study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50161
Enrollment
75
Registered
2020-06-25
Start date
2020-06-25
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 SARS-CoV-2

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Not able or willing to give informed consent

Design outcomes

Primary

MeasureTime frame
Levels of serum antibody response to SARS-CoV-2 and phenotypic and functional characterisation of SARS-CoV-2-specific T cells.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)