The aim of this study is to collect nasal fluid (mucosal lining fluid) from patients with a confirmed SARS-CoV-2 infection who remain in home isolation, as well as from their household contacts who remain in home quarantine. We aim to measure…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This is an exploratory study in which the primary aim is to study the
development of antibodies to SARS-CoV-2 in nasal fluid of COVID-19 patients and
their household contacts.
Primary outcome:
- Descriptive analysis of SARS-CoV-2 IgG and IgGA concentrations in nasal fluid
at the various time points.
Secondary outcome
- Detection of SARS-CoV-2 in diagnostic specimen
- Descriptive analysis of inflammatory markers in nasal fluid
- Descriptive analysis of correlation of antibodies with viral diagnostics and
disease symptoms
Background summary
COVID-19 is caused by the new coronavirus SARS-CoV-2. The WHO has recently
declared the SARS-CoV-2 outbreak a pandemic, and it has already sparked major
disruptions in daily life, including in the Netherlands.
The majority of COVID-19 patients has fever and respiratory complaints. In the
Netherlands, patients with a suspician of COVID-19 need to be notified to the
GGD. To prevent further spread, patients will remain in home quarantine,
awaiting diagnostic testing. The GGD will then organize a home visit for
collection of a diagnostic specimen. Following a positive diagnostic test,
patients will remain in home isolation, if the home situation permits.
High-risk contacts including household contacts will be actively monitored by
the GGD and are not allowed to go to school or work for 14 days (home
quarantine). Household contacts are currently not tested anymore due to limited
diagnostic capacity. Because household contacts of a confirmed case already
remain in home quarantine and there are not yet effective interventions
available, additional diagnostic testing does not influence clinical decision
making.
At the moment there is no knowledge about the immunological response to
SARS-CoV-2 infection. It remains unknown whether (sub)clinical infection with
SARS-CoV-2 results in a mucosal immune response. An important question is
whether subclinical infections, particularly in children, contribute to the
spread of coronavirus.
Study objective
The aim of this study is to collect nasal fluid (mucosal lining fluid) from
patients with a confirmed SARS-CoV-2 infection who remain in home isolation, as
well as from their household contacts who remain in home quarantine. We aim to
measure antibodies and other immunological biomarkers against SARS-CoV-2 in
collected samples.
Study design
This is a monocenter, prospective observational cohort study with non-invasive
procedures.
Study burden and risks
The collection of nasal fluid can cause sneezing and watery eyes. This is of a
temporary nature and there are no major risks associated with participation. We
have reduced the number of collection time points as much as possible.
Geert Grooteplein 10
Nijmegen 6500HB
NL
Geert Grooteplein 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Patient with a laboratory-confirmed SARS-CoV-2 infection in home isolation with
at least two household contacts remaining in home quarantine at the same
address.
Exclusion criteria
Patients with a negative indication for home isolation
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 | NL73418.091.20 |