It is poorly understood whether asymptomatic patients infected with SARS-CoV-2 develop an effective immune response. A better understanding of this immune response is important, as it relates to theories on the development of group immunity and the…
ID
Bron
Verkorte titel
Aandoening
SARS-CoV-2
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary objective is to determine the quantity and quality of antibody and T-cell responses to SARS-CoV-2 in asymptomatic patients who tested positive for SARS-CoV-2 with RT-PCR prior to interventions.
Achtergrond van het onderzoek
Rationale: It is poorly understood whether asymptomatic patients infected with SARS-CoV-2 develop an effective immune response. A better understanding of this immune response is important, as it relates to theories on the development of group immunity and the spread of SARS-CoV-2 in the general population. According to the revised national Dutch guideline, preoperative screening should be performed in all asymptomatic patients undergoing surgery using SARS-CoV-2 reverse-transcription-polymerase-chain-reaction (RT-PCR). This screening enables us to identify asymptomatic patients who are SARS-CoV-2 positive for further investigation of their immune response.
Objective: To evaluate the presence and levels of SARS-CoV-2 antibodies and SARS-CoV-2 specific T cell responses in asymptomatic patients who tested positive for SARS-CoV-2 with RT-PCR prior to an intervention.
Study design: Multicenter prospective observational cohort study.
Study population: Adult asymptomatic patients, who underwent preprocedural screening and tested positive for SARS-CoV-2 using RT-PCR. For secondary analyses our cohort will be compared to participants of two different ongoing cohort studies, namely a mildly symptomatic cohort of healthcare workers and a mild to severe symptomatic cohort of hospital admitted patients.
Intervention (if applicable): Study related interventions are obtaining of three or four venous blood samples and three short questionnaires by telephone.
Main study parameters/endpoints: The main study parameter is the level of SARS-CoV-2 antibodies and SARS-CoV-2 specific T cell responses in asymptomatic patients who tested positive for SARS-CoV-2 prior to a procedure, measured at least four weeks after positive screening.
Doel van het onderzoek
It is poorly understood whether asymptomatic patients infected with SARS-CoV-2 develop an effective immune response. A better understanding of this immune response is important, as it relates to theories on the development of group immunity and the spread of SARS-CoV-2 in the general population.
Onderzoeksopzet
2 weeks, 4-6 weeks, 3 months, 6 months and 12 months
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Not able or willing to give informed consent.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8733 |
| Ander register | METC AMC : METC 2020_138 |