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SARSLIVA 2.0: Dense saliva sampling for studying SARS-CoV-2 transmission dynamics - a household study

SARSLIVA 2.0: Dense saliva sampling for studying SARS-CoV-2 transmission dynamics - a household study - SARSLIVA 2.0

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56357
Enrollment
500
Registered
2022-02-28
Start date
2022-02-16
Completion date
Unknown
Last updated
2025-08-25

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

Sponsors

Overige Ziekenhuizen
Lead Sponsor

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 the index patient and at least 2 individuals that were not infected by SARS-CoV-2 during the previous 8 weeks, confirmed by either PCR or antigen test, 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

Design outcomes

Primary

MeasureTime frame
- SARS-CoV-2 transmission dynamics in households using saliva, as a sensitive and non-invasive sampling method, allowing high-density sampling - The emergence of SARS-CoV-2 in saliva from asymptomatic or pre-symptomatic household contacts, duration of the presence of SARS-CoV-2 in saliva, and the changes in viral load over time. - Clinical symptoms and severity of disease, i.e. the type and severity of symptoms, duration of symptoms, requiring hospitalization for supportive care and the duration of hospitalization, and requiring ICU admission for mechanical ventilation. Follow up: - Post-acute sequelae of SARS-CoV-2 infection, such as quality of life and clinical symptoms at 6 and 12 months (*PASC*), using questionnaires. 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

MeasureTime frame
-Change or development of antibodies against SARS-CoV-2 in saliva and serum will be assessed and the correlation between serum and saliva antibodies will be studied. - SARS-CoV-2 transmission dynamics in households using saliva, as a sensitive and non-invasive sampling method compared to SARS-CoV-2 transmission dynamics in households during the previous SARSLIVA study Reinfection substudy: - Incidence rate of (co-)infections with influenza viruses and RSV

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)