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. The secondary objectives are:- To determine…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Levels of serum antibody response to SARS-CoV-2 and phenotypic and functional
characterisation of SARS-CoV-2-specific T cells.
Secondary outcome
- 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).
Background summary
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). In the SCOUT-1 study
the yield of preoperative screening was evaluated. Additionally, the screening
enables us to identify asymptomatic patients who are SARS-CoV-2 positive for
further investigation of their immune response.
Study objective
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.
The secondary objectives are:
- To determine the level of serum antibody response to other (seasonal)
coronaviruses.
- To evaluate the effect of age, comorbidity and RT-PCR cycling threshold
values as predictors for immune responses to SARS-CoV-2.
- To evaluate the development of antibody and T-cell responses over time (up to
one year after positive testing).
The tertiairy objective is:
To compare levels of antibody and T-cell responses to SARS-CoV-2 of
asymptomatic patients with those of mild and severe symptomatic patients with
laboratory-confirmed COVID-19 (collaboration with METC study 2020_154 and
RECoVERED study, ZonMw funded).
Study design
Multicenter prospective observational study.
Study burden and risks
Participation in the SCOUT-2 study brings minimal burden and a negligible risk
for participants. Patients are exposed to extra peripheral blood sample
collection (72ml per study visit, max. 5 visitis). To enhance patients comfort
we will obtain the blood samples during a surgical follow-up visit or at home,
if required by the patient. Questionnaires on symptoms will be taken by
telephone, which will take a few minutes of the participant*s time.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
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 |
|---|---|
| CCMO | NL74280.018.20 |