The primary objective of this study is to validate the current COVID-19 criteria (for non-vulnerable and vulnerable populations) with data obtained by 'De Corona Check' app and a novel SARS-CoV-2 assay (developed by Sanquin). The secondary…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are the sensitivity and specificity of the current
COVID-19 RIVM guidelines to distinguish between SARS-CoV-2 IgM or IgG antibody
positive subjects, as measured by the newly developed assay of Sanquin. In
addition, modelling will be used to create a receiver-operator curve of
individual symptoms and signs, that may result in criteria with better test
characteristics, or alternative criteria that may be used in different
populations.
Participants will be divided in non-vulnerable and vulnerable participants.
Participants are deemed vulnerable if: they are 70 years of age or older, use
immunosuppressive medication, or if they have been diagnosed with a) chronic
lung problems, b) heart disease, c) diabetes, OR d) an immune disorder.
Non-vulnerable participants meet the COVID-19 criteria if their temperature is
above 37.9 degrees and if their cough score is above 3 (out of 10 on the
numeric cough scale) and/or their shortness of breath score is above 5 (out of
10 on the numeric dyspnea scale). For vulnerable participants a more strict
temperature cut-off of > 37.4 is applied. In these two groups the true
incidence of COVID-19 as measured by SARS-CoV-2 IgM or IgG positivity will be
compared to the number of subjects fulfilling the current COVID-19 criteria as
defined by the RIVM. If appropriate, the current criteria will be updated.
Secondary outcome
The secondary endpoint of this study is to evaluate whether SARS-CoV-2 IgM or
IgG positive subjects are protected from re-infection with SARS-CoV-2. After 6
months of follow-up we will ask these participants whether they have
experienced a second disease course of COVID-19. This second disease course of
COVID-19 will be defined as the presence of COVID-19 related complaints, a
hospital admission due to COVID-19, a positive PCR and/or a suspected
Computerized Tomography (CT) of the lungs.
Background summary
From mid-March the Dutch government has established measures to prevent
SARS-CoV-2 from spreading too fast and flatten the curve of infection rates in
The Netherlands. One of the measures taken is that people need to go in
quarantine after reporting a fever in combination with complaints of the upper
airways, i.e. cough and/or dyspnoea. However, there is a need for validation of
these current COVID-19 quarantine criteria using SARS-CoV-2 serology. In
addition, this data would also be useful to evaluate whether re-infection with
SARS-CoV-2 is possibl (manuscript is available via
https://www.medrxiv.org/search/vogelzang).
Study objective
The primary objective of this study is to validate the current COVID-19
criteria (for non-vulnerable and vulnerable populations) with data obtained by
'De Corona Check' app and a novel SARS-CoV-2 assay (developed by Sanquin). The
secondary objective of this study is to investigate whether SARS-CoV-2 IgM or
IgG positive subjects are protected for re-infection with SARS-CoV-2.
Study design
This is a prospective observational study with a follow-up of 6 months. The
true incidence of COVID-19, as defined by SARS-CoV-2 IgM or IgG positivity will
be compared to the number of subjects fulfilling the current COVID-19 criteria,
as defined by the RIVM. In addition, after 6 months of follow-up we will
evaluate whether SARS-CoV-2 IgM or IgG antibody positive subjects can go
through a second disease course of COVID-19.
Study burden and risks
We will invite current users of 'De Corona Check' app to the OLVG to draw 10 ml
of blood. We will also ask participants their permission to use their data from
'De Corona Check' app. SARS-CoV-2 IgM or IgG antibody positive subjects will be
asked to complete an additional questionnaire after 6 months of follow-up.
Therefore, the burden and risks associated with participation are negligible.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
- At least 1 complete day of data-entry in 'De Corona Check' app
Exclusion criteria
- Language problems precluding the completion of the questionnaire;
- Lack of 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 | NL73835.041.20 |