Corona Immunitas: a nationwide program of antibody studies of SARS-CoV-2 in the Swiss population
| ISRCTN | ISRCTN18181860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18181860 |
- Submission date
- 09/07/2020
- Registration date
- 13/07/2020
- Last edited
- 29/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The increasing number of persons diagnosed with a SARS-CoV-2 infection in February and March 2020 and the subsequent Swiss Federal Council's measures had major implications for public life and for the economy. For guidance after these measures have lifted and for future policy decisions on how to minimize the disease and societal burden of SARS-CoV-2 reliable epidemiological data is needed. The knowledge of the nation-wide prevalence of SARS-CoV-2 infection at the level of the population, in different geographical areas and of specific age groups is required. This knowledge will also help prepare future outbreak responses and is important to inform future vaccination strategies.
In a number of Swiss Cantons, studies on the seroprevalence of SARS-CoV-2 antibodies and the extent and duration of immunity are planned or have already started. The interest for such epidemiological studies comes from both Cantonal authorities and scientists who want to learn about the seroprevalence of SARS-CoV-2 antibodies, both in the general population (across age ranges) and in specific groups of persons (e.g. nursing home residents, working in specific sectors of economy, from citizens, etc.).
The scientists of the Swiss School of Public Health (SSPH+) have agreed to coordinate their effort in order to make their data as comparable as possible, to create synergies and reduce redundancies. The goal is to make the studies informative for policy makers on the national and Cantonal level while fully respecting the autonomy of the Cantons and scientists involved. SSPH+ is committed to shed light on the extent of the spread of SARS-CoV-2, as quickly as possible, in Switzerland, and has launched an initiative with the aim of acquiring funding from public and private sources (https://www.corona-immunitas.ch/).
The aim of this study is to determine the extent and nature of infection with SARS-CoV-2 in the general population and in specific subgroup in different Cantons of Switzerland, after the first major wave and in further epidemic phases of SARS-CoV-2, and to contribute to consistent estimates in the Swiss population.
Who can participate?
All persons who are invited to participate in the study (randomly selected participants from the general population and specific sub-populations).
What does the study involve?
Study participation includes 1) the completion of the baseline questionnaire; 2) the collection of a peripheral blood sample by venipuncture for determination of SARS-CoV-2 antibodies at a study center, a mobile unit or the participant’s home; and 3) the invitation to fill-in a weekly and monthly digital follow-up questionnaire for the next 6 to 12 months.
Specific sub-populatiopns of participants will be re-invited for repeated blood collection for SARS-CoV-2 antibody tests, where the same procedures will be used.
What are the possible benefits and risks of participation?
The primary benefit of the study is indirect. The evaluation of the SARS-Cov-2 seroprevalence in the general population and specific subgroups is essential to understand what phase of the epidemic we are currently in, to be able to make predictions for the continuation of the epidemic and to put in place adequate public health measures. It will also provide information on the proportion of oligo- and asymptomatic cases. The publication of these results as open access will be useful to the entire international scientific community as well as other stakeholders including guideline developers, policy makers and physicians.
The risk associated with the collection of blood samples is very low. Possible complications are minor and include a hematoma at the puncture site, infection, or vagal discomfort during blood collection. All safety measures will be taken to prevent these complications from occurring by adopting standard collection rules and working with registered nurses. There is also a risk of SARS-CoV-2 infection on the way from participants' homes to the study centers and during contact at the study site. We have tried to minimize this risk; during all interactions, study staff will follow current standard hygiene procedures (hand washing and disinfection procedures, wearing masks and gloves) and participants will wear a mask, provided by the study staff. The mobile investigation teams who travel to conduct the study visit at the participants’ home will follow the same procedures.
Where is the study run from?
Swiss School of Public Health (SSPH+), an inter-university faculty that unites twelve Swiss universities, coordinates nationwide the seroprevalence studies. The responsible study centers in the participating Swiss Cantons run the studies.
When is the study starting and how long is it expected to run for?
March 2020 to April 2023
Who is funding the study?
Corona Immunitas is funded by several sources: All: by fundraising of SSPH+ that includes funds of the Federal Office of Public Health and private funders (foundations, companies and private donations; ethical guidelines for funding stated by SSPH+ will be respected); center specific by funds of the Cantons, by institutional funds of the Universities and by other center-specific sources.
Who is the main contact?
Prof. Dr. med. et phil. Milo A. Puhan, miloalan.puhan@uzh.ch
Contact information
Scientific
Epidemiology, Biostatistics and Prevention Institute
University of Zurich
Hirschengraben 84
Zurich
8001
Switzerland
 ORCID ID |
0000-0003-4721-1879 |
|---|---|
| Phone | +41 44 634 46 10 |
| miloalan.puhan@uzh.ch |
Public
Epidemiology, Biostatistics and Prevention Institute
University of Zurich
Hirschengraben 84
Zurich
8001
Switzerland
| ORCID ID |
0000-0003-1113-9895 |
|---|---|
| Phone | +41 44 634 46 79 |
| jan.fehr@uzh.ch |
Scientific
Epidemiology, Biostatistics and Prevention Institute
University of Zurich
Hirschengraben 84
Zurich
8001
Switzerland
| ORCID ID |
0000-0002-7134-1000 |
|---|---|
| Phone | +41 44 634 43 60 |
| anja.frei@uzh.ch |
Study information
| Study design | Cross-sectional and longitudinal studies in the general population and in specific subpopulations with serological testing at baseline and a digital-only or combined digital and serological follow-up |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-sectional and longitudinal |
| Study setting(s) | Community |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN18181860_PIS_v4_11Jun2020.pdf |
| Scientific title | Seroprevalence of SARS-CoV-2 antibodies and development of immunity in the Swiss population – Multicenter population-based observational studies to inform policy making |
| Study acronym | Corona Immunitas |
| Study hypothesis | The main goal of the Corona Immunitas research program is to determine the extent and nature of infection with SARS-CoV-2 in all regions of Switzerland in a highly consistent and comprehensive way in the general Swiss population as well as particularly exposed and vulnerable groups. Specific aims are to: 1) quantify the number of individuals infected with SARS-CoV-2 in the population with or without symptoms at several points in time; 2) compare the seroprevalence between the general population and specific subpopulations; 3) investigate the nature and extent of immunity after infection; 4) assess the association between participant characteristics and behaviors with infection; and 5) quantify the impact of the pandemic on mental and physical health. Most importantly, this evidence-based program aims to provide policy-makers and other decision makers with important evidence for deciding which public health and setting-specific measures to implement or lift for the general population and specific subpopulations at different points in time. |
| Ethics approval(s) | Approved 28/05/2020, Cantonal Ethics Committee Zurich (Stampfenbachstrasse 121, CH-8090 Zurich, Switzerland; +41 43 259 79 70; Info.KEK@kek.zh.ch), ref: 2020-01247 |
| Condition | SARS-CoV2 infection (COVID-19) |
| Intervention | Potential participants are either randomly selected from the general population or selected from specific sub-population settings. The process of enrollment is organized by each study center and for each population individually. Generally, potential participants are informed and invited to participate in the study by postal mail or email and asked to schedule an appointment for a study visit either at a study center, at a mobile unit (bus) or at their home (vulnerable persons). Before the study visit, participants are provided with the link to an online baseline questionnaire asking demographic questions, symptoms, other tests taken for SARS-CoV-2, preventative measure behaviors and quality of life measures. After providing informed consent, the study visit is conducted by trained study personnel. The expected duration of the visit is 20-30 minutes in total and data is assessed in three stages: 1. Study staff checks the completeness of the baseline questionnaire and, if incomplete, advises the participant to complete it on a computer, tablet or on paper/pencil. 2. Trained health care staff collects a peripheral blood sample by venipuncture for the determination of SARS-CoV-2 antibodies (quantity varies according to study site). The participants are explained orally and by a leaflet how to interpret a positive serological test result (probability that result is inaccurate) and are instructed to keep on following the recommendations of the public health authorities, regardless of their individual test result. The entire sequence from blood withdrawal to storage and testing follows a Standardized Operating Procedure. 3. Participants are invited to fill in a weekly and monthly digital follow-up questionnaire for the next 6 to 12 months, capturing health status, symptoms and behaviors over time. Specific groups of participants will be re-invited for repeated blood collection for SARS-CoV-2 antibody testing, once or several times. |
| Intervention type | Other |
| Primary outcome measure | Seroprevalence of SARS-CoV-2 antibodies measured using peripheral blood sample by venipuncture in the general population and in specific subpopulations at repeated time points during the epidemic in Switzerland |
| Secondary outcome measures | 1. Presence of symptoms suggestive of a common cold, influenza and similar upper respiratory tract infections prior to the first study visit. Measured by baseline questionnaire (at baseline) 2. Potential risk factors and preventive measures for SARS-CoV-2 infection (exposure, socio-economic factors, adherence to general hygiene and physical distancing rules, utilization of mask and gloves). Measured by baseline questionnaire (at baseline) 3. Incidence of self-reported symptoms and SARS-CoV-2 infections after the first study visit in initially seropositive individuals (extent and duration of immunity after infection with SARS-CoV-2). Measured by digital follow-up questionnaire (weekly) 4. Proportion of seronegative individuals of the first investigation wave who will self-report symptoms and infection with SARS-CoV-2. Measured by digital follow-up questionnaire (weekly) 5. Course over time in access to health care, health care renunciation, going outside (frequency, reason, physical activity), preventive measures with respect to COVID-19. Measured by digital follow-up questionnaire (weekly and monthly) 6. Course over time in mental well-being, specifically stress, anxiety and depression. Measured by digital follow-up questionnaire (monthly) |
| Overall study start date | 18/03/2020 |
| Overall study end date | 31/03/2023 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | All |
| Sex | Not Specified |
| Target number of participants | In the frame of Corona Immunitas, it is planned to include around 25,000 participants in the different Cantons / centers of Switzerland. |
| Total final enrolment | 28000 |
| Participant inclusion criteria | 1. No acute SARS-CoV-2 infection: no presence of symptoms for at least 48 hours 2. In case of a SARS-CoV-2 infection verified by a RT-PCR test, the earliest inclusion is 21 days after the test date |
| Participant exclusion criteria | 1. No informed consent 2. Suspicion of acute COVID-19 infection |
| Recruitment start date | 01/04/2020 |
| Recruitment end date | 31/12/2022 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Hirschengraben 84
Zurich
8001
Switzerland
Department of Community Health
Faculty of Science and Medicine
Route des Arsenaux 41
Fribourg
1700
Switzerland
Via G. Buffi 13
Lugano
6900
Switzerland
Avenue des Casernes 2
Lausanne
1014
Switzerland
Rue Gabrielle-Perret-Gentil 4
Geneva
1205
Switzerland
Socinstrasse 57
Basel
4051
Switzerland
Neuchâtel
2000
Switzerland
Forschungsstelle Gesundheitswissenschaften
Katharina-Sulzer-Platz 9
Winterthur
8400
Switzerland
Rorschacherstrasse 95
St. Gallen
9007
Switzerland
Chur
7000
Switzerland
Mittelstrasse 43
Bern
3012
Switzerland
Route des Arsenaux 41
Fribourg
1700
Switzerland
Frohburgstrasse 3
Luzern
6002
Switzerland
Sion
1950
Switzerland
Sponsor information
University/education
SSPH+ Foundation
Prof. Dr. med et PhD Nino Künzli
Hirschengraben 82
Zurich
8001
Switzerland
| Phone | +41 44 634 47 02 |
|---|---|
| info@ssphplus.ch | |
| Website | https://ssphplus.ch/ |
"ROR" |
https://ror.org/01czqbr06 |
Funders
Funder type
Government
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The de-identified individual participant data generated during the current study are available upon request. Data access guidelines, database documentation and description are provided in Zenodo: 1. Corona Immunitas Phases 1 to 4 - Central Database: https://zenodo.org/record/7520050 2. Corona Immunitas Phases 5 and 6 - Central Database: https://zenodo.org/record/7520125 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | early results | 01/08/2020 | 09/07/2020 | Yes | No |
| Participant information sheet | version v4 | 11/06/2020 | 07/08/2020 | No | Yes |
| Protocol article | protocol | 01/12/2020 | 26/10/2020 | Yes | No |
| Results article | Seroprevalence and attitudes of care home and in-home care staff | 16/03/2022 | 18/03/2022 | Yes | No |
| Results article | Results from the Swiss national seroprevalence study Corona Immunitas | 20/06/2022 | 21/06/2022 | Yes | No |
| Results article | Association of plasma zinc levels with anti-SARS-CoV-2 IgG and IgA seropositivity in the general population: A case-control study | 18/04/2023 | 03/05/2023 | Yes | No |
| Results article | Recovery and symptom trajectories up to 2 years after SARS-CoV-2 infection | 31/05/2023 | 01/06/2023 | Yes | No |
| Dataset | Corona Immunitas Phases 1 to 4 - Central Database | 26/04/2023 | 29/08/2023 | No | No |
| Dataset | Corona Immunitas Phases 5 and 6 - Central Database | 26/04/2023 | 29/08/2023 | No | No |
| Other publications | Protocol and initial results of Corona Immunitas Digital Follow-Up eCohort | 28/02/2022 | 29/08/2023 | Yes | No |
| Results article | Association between serologically confirmed COVID-19 infection and cognitive functioning in community dwelling older adults | 21/03/2023 | 29/08/2023 | Yes | No |
| Results article | Changes in socioeconomic resources and mental health after the second COVID-19 wave | 23/03/2023 | 29/08/2023 | Yes | No |
| Results article | Functional immunity against SARS-CoV-2 in the general population after a booster campaign and the Delta and Omicron waves | 01/08/2022 | 29/08/2023 | Yes | No |
| Results article | Impact of screen time and green time on mental health in children and adolescents during the COVID-19 pandemic | 01/08/2022 | 29/08/2023 | Yes | No |
| Results article | Longitudinal humoral and cell-mediated immune responses | 01/08/2023 | 29/08/2023 | Yes | No |
| Results article | Prevalence and association of frailty with SARS-CoV-2 infection in older adults | 12/01/2023 | 29/08/2023 | Yes | No |
| Results article | SARS-CoV-2 infection among employees working from home and on site | 16/09/2022 | 29/08/2023 | Yes | No |
| Results article | SARS-CoV-2 seroprevalence and COVID-19 disease among people on opioid agonist treatment | 12/01/2022 | 29/08/2023 | Yes | No |
| Results article | Seroprevalence trends of anti-SARS-CoV-2 antibodies and associated risk factors | 04/03/2023 | 29/08/2023 | Yes | No |
| Results article | Trajectories of depression, anxiety and stress during the pandemic | 01/05/2022 | 29/08/2023 | Yes | No |
| Results article | Vaccination intention, beliefs, attitudes, and trust | 23/03/2022 | 29/08/2023 | Yes | No |
Additional files
- ISRCTN18181860_PIS_v4_11Jun2020.pdf
- uploaded 07/08/2020
Editorial Notes
29/08/2023: The following changes have been made:
1. Publication references added.
2. The overall study end date has been changed from to 08/04/2023 and the plain English summary updated accordingly.
3. The final enrolment number has been added.
4. The IPD sharing plan and sharing summary have been added.
5. Dataset links have been added.
01/06/2023: Publication reference added.
03/05/2023: Publication reference added.
09/01/2023: The overall trial start date has been changed from 31/12/2022 to 31/03/2023 and the plain English summary updated accordingly.
21/06/2022: Publication reference added.
17/06/2022: The intention to publish date has been changed from 31/12/2022 to 30/06/2023.
30/05/2022: The following changes have been made:
1. The study design has been changed from "A group of prospective observational cohort studies" to "Cross-sectional and longitudinal studies in the general population and in specific subpopulations with serological testing at baseline and a digital-only or combined digital and serological follow-up".
2. The secondary study design has been changed from 'Cohort study' to 'Other'.
3. The overall trial start date has been changed from 18/03/2019 to 18/03/2020 and the plain English summary updated accordingly.
18/03/2022: Publication reference added.
18/10/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2021 to 31/12/2022.
2. The overall end date was changed from 31/10/2022 to 31/12/2022.
3. The trial participating centre Observatoire valaisan de la santé was added.
4. The plain English summary was updated to reflect these changes.
07/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2020 to 31/10/2021.
2. The overall trial end date has been changed from 31/12/2021 to 31/10/2022 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/03/2021 to 31/12/2022.
4. The trial participating centres "Zürcher Hochschule für Angewandte Wissenschaften (ZHAW)", "Kantonsspital St. Gallen", "Kantonsspital Graubünden", "Universität Bern", "University of Fribourg", and "University of Lucerne" have been added.
26/10/2020: Publication reference added.
07/08/2020: The participant information sheet was uploaded as an additional file.
10/07/2020: Trial’s existence confirmed by Cantonal Ethics Committee Zurich.
