Coronavirus Covid-19
Conditions
Interventions
None listed
Sponsors
Spaarne Gasthuis
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: Age index case 0-65 years, and - Laboratory-confirmed COVID-19 of index case, and - Household living together with at least 3 individuals, including the index patient, and - Informed consent of index-patient and at least 2 other household members
Exclusion criteria
Exclusion criteria: - Not able to read a Dutch patient information leaflet, or - Living more than 50 km from the Spaarne hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To address the primary objectives, the following parameters will be evaluated: - The sensitivity of testing for SARS-CoV-2 in saliva compared to routine diagnostics performed on NP or OP swabs, or a combination of the two. - The duration of the presence of SARS-CoV-2 in saliva and the changes in viral load over time. - The emergence of SARS-CoV-2 in saliva from asymptomatic or pre-symptomatic household contacts. - The emergence of SARS-CoV-2 specific IgA, IgM and IgG antibodies in saliva over time, and the concordance between salivary and serum antibodies. FUP: - Analyses of levels of different neutralizing and non-neutralizing antibodies in serum and saliva using microarray approach at 6 and 12 months after SARS-CoV-2 infection. - Measuring antibody response after vaccination in both serum and saliva using microarray - Questionnaires to study long-term sequelae of SARS-CoV-2 infection, such as quality of life and clinical symptoms at 6 and 12 months (*Long COVID*). Reinfection substudy: - Incidence rate of SARS-CoV-2 reinfections. - Risk factors (demographic, clinical, virological, immunological) for SARS-CoV-2 reinfections. - Factors that determine the longevity and breadth of protective SARS-CoV-2-specific humoral and cellular immunity - The health impact of SARS-CoV-2 reinfections or their sequelae | — |
Secondary
| Measure | Time frame |
|---|---|
| To address the secondary objective, the following will be evaluated: - Presence of other respiratory viruses in saliva. - Presence of respiratory bacterial pathogens in NP, OP swabs and saliva FUP: - In case of re-infection SARS-CoV-2 viral load will be measured by PCR and determination of SARS-CoV-2 genotype by sequencing. Antibody at time of re-infection and response after 6 weeks will be measured in both serum and saliva. - Presence of respiratory bacterial pathogens in saliva at month 6 and 12. Reinfection substudy: - Incidence rate of (co-)infections with influenza viruses and RSV | — |
Countries
Netherlands
Outcome results
None listed