Validation of the RIVM COVID-19 criteria within 'De Corona Check' app using SARS-CoV-2 serology

Validation of the RIVM COVID-19 criteria within 'De Corona Check' app using SARS-CoV-2 serology - Validation of the current COVID-19 criteria using SARS-CoV-2 serology

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49450

Enrollment

2000

Registered

2020-11-10

Start date

2020-12-01

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

coronavirus COVID-19

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - At least 1 complete day of data-entry in 'De Corona Check' app

Exclusion criteria

Exclusion criteria: - Language problems precluding the completion of the questionnaire; - Lack of informed consent.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results