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| Name | Class |
|---|---|
| University of Geneva, Switzerland | OTHER |
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This single-center prospective observational study will examine immune responses to to SARS-CoV-2 and how they correlate with its virological characteristics and clinical manifestations in infected patients. Household contacts will also be included so that early immune responses and viral kinetics can be captured. Patients and contacts will be followed for 8 and 2 weeks, respectively. The study will include a maximum of 250 participants.
The primary aim of this single-center prospective observational study is to establish how immune responses to SARS-CoV-2 or to cross-reactive viruses correlate with the virological and clinical characteristics of SARS- CoV-2-infected patients and their exposed household contacts. Through iterative sampling, the viral kinetics of at least 50 infected patients will be evaluated in relation to symptom severity and innate and adaptive immune responses, while their household contacts will be observed for viral detection and immune responses. Patients and contacts will be followed for 8 and 2 weeks, respectively. The study will include a maximum of 250 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Cases are patients with COVID-19. |
| |
| Contacts | Contacts are household contacts of an index (case) patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NA (no intervention) | Other | NA (no intervention) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity primary outcome: Geometric mean antibody concentration of total IgG antibodies to SARS-CoV-2 assessed by ELISA at 28 days | Geometric mean antibody concentration of total IgG antibodies to SARS-CoV-2 assessed by ELISA at 28 days after diagnosis/suspected diagnosis | assessed at 28 days after diagnosis/presumed diagnosis |
| Virologic primary outcome: Peak viral load in the 56 days following diagnosis/suspected diagnosis | Peak viral load in the 56 days following diagnosis/suspected diagnosis, quantified by real-time reverse-transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swabs. | 56 days after diagnosis/presumed diagnosis |
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Inclusion Criteria:
The following persons may be included:
Exclusion Criterion:
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Adults and children of all ages either infected with, or presumed to be infected with SARS-CoV-2, and their household contacts.
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| Name | Affiliation | Role |
|---|---|---|
| Claire-Anne Siegrist, MD | Professor of vaccinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva | Geneva | 1211 | Switzerland |
Fully anonymized data that are not already published may be shared on reasonable request from a qualified investigator, at the discretion of the Project Leader.
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| ID | Term |
|---|---|
| D012964 | Sodium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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naso- & oro-pharyngeal smears, sputum, blood
| D008670 |
| Metals |