SARS Coronavirus (SARS-CoV-2) InfectionNCT04351503
A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City; COVID-19
An observational study of SARS Coronavirus (SARS-CoV-2) Infection, run by University Hospital, Basel, Switzerland at 6 sites in Switzerland.
Trial summary
This study is to gain critical knowledge to understand the factors influencing the outcome of a pandemic virus within the city of Basel. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS Coronavirus (SARS-CoV-2) Infection
- What is being tested?
- Study A, Study B and Study C
- How many people
- 126,586 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 9 Apr 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: SARSCoV- 2 infected patients and non-SARS-CoV-2 infected patients with or without other respiratory viruses with residency in Basel (Basel-Stadt, Riehen, and Bettingen)
Who may be able to join
- Study A: All patients being tested for SARS-CoV-2 at the University Hospital Basel (USB) and with residency in Basel (Basel-Stadt, Riehen, and Bettingen) will be included for clinical outcome evaluation. All age groups will be included. In addition, non-clinical data such as epidemiological and hospital associated data of all people living in Basel but not necessarily tested at the University Hospital Basel will be included
- Study B: Epidemiological data and serum and respiratory samples across all Age groups from people with residency in Basel (Basel-Stadt, Riehen, and Bettingen) with and without confirmed SARS-CoV-2 infection will be included
- Study C: SARS-CoV-2 viral genome analysis will be conducted from all patients tested positive for SARS-CoV-2 genome by NAT at the University Hospital Basel and living in Basel (Basel-Stadt, Riehen, and Bettingen). In addition, viral genome analysis will be conducted from all people tested positive for SARS-CoV-2 genome by NAT living in Basel by the mentioned study partners. All Age groups will be included.
- Patients with cleared SARS-CoV-2 infection coming for plasma donation will be included to describe immunological response after successfully cleared infection.
Who cannot join
- documented refusal of the general consent or an available/known written or oral statement against Research
- People, who are tested at the USB, with residency outside of Basel (Basel-Stadt, Riehen, and Bettingen)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Viollier AG
Allschwil, 4123
University Hospital Basel
Basel, 4031
Biozentrum University of Basel
Basel, 4056
sciCore University of Basel
Basel, 4056
Department of Biosystems Science and Engineering ETH Zurich
Basel, 4058
Swiss Institute of Bioinformatics
Geneva, 1202
About this study
Official title: A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City
This study is to gain critical knowledge to understand the factors influencing the outcome of a pandemic virus within the city of Basel.
Read the detailed description
In order to evaluate the impact of the new SARS-CoV-2 this study analyzes the clinical outcomes of patients with a confirmed SARS-CoV-2 infection using a systems approach. The objective is to integrate various datasets covering clinical and non-clinical variables. Beside host factors such as age, gender, comorbidities and treatments, microbiological factors, such as SARS-CoV-2 viral loads using a (semi)-quantitative nucleic acid test (QNAT), genome sequences, and virus-specific immune responses are included. In addition, epidemiological aspects within the city, such as case numbers in specific areas and resulting saturation of the healthcare system (e.g. patients being hospitalized, and ICU occupancy), will be analyzed. Further epidemiological data will be generated from biological measurements from all available serum and respiratory samples (leftover material) collected from February 2020 to November 2021 over two seasons as it is likely that a second wave will be circulating in the following winter 2020/2021.
In this project, three retrospective studies will be conducted:
Study A: retrospective observational case-control study to predict the clinical outcomes and features of SARS-CoV-2 infection. The clinical outcomes of SARSCoV-2 infected patients (cases) and non-SARS-CoV-2 infected patients with or without other respiratory viruses (control) will be explored.
Study B: retrospective observational epidemiological surveillance study to describe the epidemiology of the SARS-CoV-2 outbreak; description of the epidemiological spread of the new SARS-CoV-2 virus in people living in Basel.
Study C: retrospective observational viral evolution study whereby respiratory materials and matching blood and tissue materials will be used to perform whole genome sequencing to study pathogen evolution between hosts as well as in-host evolution. No additional material will be collected. Virus genomes obtained during the expanding, peak, and contracting phase of the pandemic will be compared to identify predictors of viral evolution, viral loads, majority species, immune escape variants, and the implications for clinical outcome, diagnostic detection, treatment, and vaccine design. Correlating specifically the occurrence and rate and variants of SARS-CoV-2 re-infections in city blocks of high activity and exposure risk will be of interest.
Study D: retrospective observational treatment outcome study whereby clinical outcome, laboratory, radiological, pulmonary function and virological data as well as data on immune responses will be used to study safety and efficacy of different treatment modalities. All data and material will be collected on a routine basis during hospitalization and in the outpatient setting to assess the safety and effect of different treatment modalities on outcome.
- Conditions
- SARS Coronavirus (SARS-CoV-2) Infection
- Being tested
- Study A, Study B, Study C, Study D
- Keywords
- Coronavirus Disease 2019 (COVID19), SARS-CoV-2 re-infection
- Medical subject headings
- Severe Acute Respiratory Syndrome, Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study AOther
Study A: collection of data of clinical outcomes and features of SARS-CoV-2 infection. Demographical, clinical, microbiological, laboratory, epidemiological and hospital-associated data will be analyzed. For this study part, only patients with a visit at the University Hospital Basel will be included in order to access patient charts.
Study BOther
Study B: collection of epidemiological surveillance data to describe the epidemiology of the SARS-CoV-2 outbreak. The epidemic transmission of Influenza viruses in the City of Basel serves as an important reference to identify similarities and differences to the pandemic SARS-CoV-2 situation. In addition data collected during the Influenza projects - in particular data on statistical blocks of the city, e.g. population density, income and living space will be re-used. Already collected and stored samples such as serum and respiratory material (leftover material) will be (re-) used.
Study COther
Study C: data collection for viral evolution. Respiratory materials and matching blood and tissue materials will be used to perform whole genome sequencing to study pathogen evolution between hosts as well as in-host evolution. No additional material will be collected.
Study DOther
Study D: collection of safety and efficacy data of different treatment modalities. Currently the following treatments are considered as part of the treatment:
- Lopinavir/Ritonavir
- Hydroxychloroquine
- Tocilizumab
- Eculizumab
- Ruxolitinib
- Remdesivir
- Treatment with convalescent plasma blood count, blood chemistry and pulmonary function test (collected on a routine basis during hospitalization and in the outpatient setting).
| Study group | Role | What they receive |
|---|---|---|
| SARSCoV-infected patients (cases) | Not described Receives: Other: Study A; Other: Study B; Other: Study C; Other: Study D | |
| non-SARS-CoV-2 infected patients (control) | non-SARS-CoV-2 infected patients with or without other respiratory viruses (control). Receives: Other: Study A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)
Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)
Measured: at baseline
duration of hospitalization (in days)
duration of hospitalization (in days)
Measured: at baseline
duration of Intensive Care Unit (ICU) stay (in days)
duration of ICU stay (in days)
Measured: at baseline
in-hospital mortality (binary, yes/no)
in-hospital mortality (binary, yes/no)
Measured: at baseline
Number of infected cases within the city of Basel
Number of infected cases confirmed either by nucleic acid test (NAT) or by positive serology within the city of Basel expressed as incidence per statistical block
Measured: at baseline
whole genome sequencing to study pathogen evolution (number, type, and complexity of viral genome)
Number, type, and complexity of viral genome variants and quasispecies identified by deep-sequencing during rise, peak, and contraction of the pandemic in patients and geographic areas.
Measured: at baseline
Identification which treatment modality is associated with adverse events (binary, yes/no)
Identification which treatment modality is associated with adverse events (binary, yes/no)
Measured: at baseline
Identification which treatment modality is associated with pulmonary recovery (binary, yes/no)
Identification which treatment modality is associated with pulmonary recovery(binary, yes/no)
Measured: after 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start9 Apr 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SARS Coronavirus (SARS-CoV-2) InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 126,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- sciCORE University of Basel, Leonhard Med IT ETH Zurich, Swiss Institute of Bioinformatics
- Responsible party
- Sponsor
- Investigators
- Adrian Egli, Prof. Dr. med., Principal investigator, Division of Clinical Bacteriology & Mycology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351503
- Sponsor's protocol ID
- 2020-00769; qu20Egli2
- Status last verified
- May 2024
- First submitted
- 15 Apr 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sava M, Sommer G, Daikeler T, Woischnig AK, Martinez AE, Leuzinger K, Hirsch HH, Erlanger T, Wiencierz A, Bassetti S, Tamm M, Tschudin-Sutter S, Stoeckle M, Pargger H, Siegemund M, Boss R, Zimmer G, Vu DL, Kaiser L, Dell-Kuster S, Weisser M, Battegay M, Hostettler K, Khanna N. Ninety-day outcome of patients with severe COVID-19 treated with tocilizumab - a single centre cohort study. Swiss Med Wkly. 2021 Aug 10;151:w20550. doi: 10.4414/smw.2021.20550. eCollection 2021 Aug 2.
PubMed 34375986Seth-Smith H, Vesenbeckh S, Egli A, Ott S. SARS-CoV-2 in an immunocompromised host: convalescent plasma therapy and viral evolution elucidated by whole genome sequencing. BMJ Case Rep. 2023 Dec 9;16(12):e255255. doi: 10.1136/bcr-2023-255255.
PubMed 38087481Peter JK, Wegner F, Gsponer S, Helfenstein F, Roloff T, Tarnutzer R, Grosheintz K, Back M, Schaubhut C, Wagner S, Seth-Smith HMB, Scotton P, Redondo M, Beckmann C, Stadler T, Salzmann A, Kurth H, Leuzinger K, Bassetti S, Bingisser R, Siegemund M, Weisser M, Battegay M, Sutter ST, Lebrand A, Hirsch HH, Fuchs S, Egli A. SARS-CoV-2 Vaccine Alpha and Delta Variant Breakthrough Infections Are Rare and Mild but Can Happen Relatively Early after Vaccination. Microorganisms. 2022 Apr 21;10(5):857. doi: 10.3390/microorganisms10050857.
PubMed 35630302Bruningk SC, Klatt J, Stange M, Mari A, Brunner M, Roloff TC, Seth-Smith HMB, Schweitzer M, Leuzinger K, Sogaard KK, Albertos Torres D, Gensch A, Schlotterbeck AK, Nickel CH, Ritz N, Heininger U, Bielicki J, Rentsch K, Fuchs S, Bingisser R, Siegemund M, Pargger H, Ciardo D, Dubuis O, Buser A, Tschudin-Sutter S, Battegay M, Schneider-Sliwa R, Borgwardt KM, Hirsch HH, Egli A. Determinants of SARS-CoV-2 transmission to guide vaccination strategy in an urban area. Virus Evol. 2022 Mar 17;8(1):veac002. doi: 10.1093/ve/veac002. eCollection 2022.
PubMed 35310621Stange M, Mari A, Roloff T, Seth-Smith HM, Schweitzer M, Brunner M, Leuzinger K, Sogaard KK, Gensch A, Tschudin-Sutter S, Fuchs S, Bielicki J, Pargger H, Siegemund M, Nickel CH, Bingisser R, Osthoff M, Bassetti S, Schneider-Sliwa R, Battegay M, Hirsch HH, Egli A. SARS-CoV-2 outbreak in a tri-national urban area is dominated by a B.1 lineage variant linked to a mass gathering event. PLoS Pathog. 2021 Mar 19;17(3):e1009374. doi: 10.1371/journal.ppat.1009374. eCollection 2021 Mar.
PubMed 33740028
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City
- ClinicalTrials.gov ID
- NCT04351503
- Acronym / sponsor ID
- 2020-00769; qu20Egli2
- Conditions
- SARS Coronavirus (SARS-CoV-2) Infection
- Keywords
- Coronavirus Disease 2019 (COVID19), SARS-CoV-2 re-infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126,586 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- sciCORE University of Basel, Leonhard Med IT ETH Zurich, Swiss Institute of Bioinformatics
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to gain critical knowledge to understand the factors influencing the outcome of a pandemic virus within the city of Basel.
Detailed description
In order to evaluate the impact of the new SARS-CoV-2 this study analyzes the clinical outcomes of patients with a confirmed SARS-CoV-2 infection using a systems approach. The objective is to integrate various datasets covering clinical and non-clinical variables. Beside host factors such as age, gender, comorbidities and treatments, microbiological factors, such as SARS-CoV-2 viral loads using a (semi)-quantitative nucleic acid test (QNAT), genome sequences, and virus-specific immune responses are included. In addition, epidemiological aspects within the city, such as case numbers in specific areas and resulting saturation of the healthcare system (e.g. patients being hospitalized, and ICU occupancy), will be analyzed. Further epidemiological data will be generated from biological measurements from all available serum and respiratory samples (leftover material) collected from February 2020 to November 2021 over two seasons as it is likely that a second wave will be circulating in the following winter 2020/2021.
In this project, three retrospective studies will be conducted:
Study A: retrospective observational case-control study to predict the clinical outcomes and features of SARS-CoV-2 infection. The clinical outcomes of SARSCoV-2 infected patients (cases) and non-SARS-CoV-2 infected patients with or without other respiratory viruses (control) will be explored.
Study B: retrospective observational epidemiological surveillance study to describe the epidemiology of the SARS-CoV-2 outbreak; description of the epidemiological spread of the new SARS-CoV-2 virus in people living in Basel.
Study C: retrospective observational viral evolution study whereby respiratory materials and matching blood and tissue materials will be used to perform whole genome sequencing to study pathogen evolution between hosts as well as in-host evolution. No additional material will be collected. Virus genomes obtained during the expanding, peak, and contracting phase of the pandemic will be compared to identify predictors of viral evolution, viral loads, majority species, immune escape variants, and the implications for clinical outcome, diagnostic detection, treatment, and vaccine design. Correlating specifically the occurrence and rate and variants of SARS-CoV-2 re-infections in city blocks of high activity and exposure risk will be of interest.
Study D: retrospective observational treatment outcome study whereby clinical outcome, laboratory, radiological, pulmonary function and virological data as well as data on immune responses will be used to study safety and efficacy of different treatment modalities. All data and material will be collected on a routine basis during hospitalization and in the outpatient setting to assess the safety and effect of different treatment modalities on outcome.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARSCoV-infected patients (cases) | – | Other: Study A, Other: Study B, Other: Study C, Other: Study D |
| non-SARS-CoV-2 infected patients (control) | – | Other: Study Anon-SARS-CoV-2 infected patients with or without other respiratory viruses (control). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SARSCoV- 2 infected patients and non-SARS-CoV-2 infected patients with or without other respiratory viruses with residency in Basel (Basel-Stadt, Riehen, and Bettingen)
Key inclusion criteria (4 listed)
- Study A: All patients being tested for SARS-CoV-2 at the University Hospital Basel (USB) and with residency in Basel (Basel-Stadt, Riehen, and Bettingen) will be included for clinical outcome evaluation. All age groups will be included. In addition, non-clinical data such as epidemiological and hospital associated data of all people living in Basel but not necessarily tested at the University Hospital Basel will be included
- Study B: Epidemiological data and serum and respiratory samples across all Age groups from people with residency in Basel (Basel-Stadt, Riehen, and Bettingen) with and without confirmed SARS-CoV-2 infection will be included
- Study C: SARS-CoV-2 viral genome analysis will be conducted from all patients tested positive for SARS-CoV-2 genome by NAT at the University Hospital Basel and living in Basel (Basel-Stadt, Riehen, and Bettingen). In addition, viral genome analysis will be conducted from all people tested positive for SARS-CoV-2 genome by NAT living in Basel by the mentioned study partners. All Age groups will be included.
- Patients with cleared SARS-CoV-2 infection coming for plasma donation will be included to describe immunological response after successfully cleared infection.
Key exclusion criteria (2 listed)
- documented refusal of the general consent or an available/known written or oral statement against Research
- People, who are tested at the USB, with residency outside of Basel (Basel-Stadt, Riehen, and Bettingen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study AStudy A: collection of data of clinical outcomes and features of SARS-CoV-2 infection. Demographical, clinical, microbiological, laboratory, epidemiological and hospital-associated data will be analyzed. For this study part, only patients with a visit at the University Hospital Basel will be included in order to access patient charts. | Other | SARSCoV-infected patients (cases), non-SARS-CoV-2 infected patients (control) |
| Study BStudy B: collection of epidemiological surveillance data to describe the epidemiology of the SARS-CoV-2 outbreak. The epidemic transmission of Influenza viruses in the City of Basel serves as an important reference to identify similarities and differences to the pandemic SARS-CoV-2 situation. In addition data collected during the Influenza projects - in particular data on statistical blocks of the city, e.g. population density, income and living space will be re-used. Already collected and stored samples such as serum and respiratory material (leftover material) will be (re-) used. | Other | SARSCoV-infected patients (cases) |
| Study CStudy C: data collection for viral evolution. Respiratory materials and matching blood and tissue materials will be used to perform whole genome sequencing to study pathogen evolution between hosts as well as in-host evolution. No additional material will be collected. | Other | SARSCoV-infected patients (cases) |
| Study DStudy D: collection of safety and efficacy data of different treatment modalities. Currently the following treatments are considered as part of the treatment: 1. Lopinavir/Ritonavir 2. Hydroxychloroquine 3. Tocilizumab 4. Eculizumab 5. Ruxolitinib 6. Remdesivir 7. Treatment with convalescent plasma blood count, blood chemistry and pulmonary function test (collected on a routine basis during hospitalization and in the outpatient setting). | Other | SARSCoV-infected patients (cases) |
Primary outcome
Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)
Time frame: at baseline
Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)
duration of hospitalization (in days)
Time frame: at baseline
duration of hospitalization (in days)
duration of Intensive Care Unit (ICU) stay (in days)
Time frame: at baseline
duration of ICU stay (in days)
in-hospital mortality (binary, yes/no)
Time frame: at baseline
in-hospital mortality (binary, yes/no)
Number of infected cases within the city of Basel
Time frame: at baseline
Number of infected cases confirmed either by nucleic acid test (NAT) or by positive serology within the city of Basel expressed as incidence per statistical block
whole genome sequencing to study pathogen evolution (number, type, and complexity of viral genome)
Time frame: at baseline
Number, type, and complexity of viral genome variants and quasispecies identified by deep-sequencing during rise, peak, and contraction of the pandemic in patients and geographic areas.
Identification which treatment modality is associated with adverse events (binary, yes/no)
Time frame: at baseline
Identification which treatment modality is associated with adverse events (binary, yes/no)
Identification which treatment modality is associated with pulmonary recovery (binary, yes/no)
Time frame: after 30 and 90 days
Identification which treatment modality is associated with pulmonary recovery(binary, yes/no)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Results publication: PubMed 34375986Sava M, Sommer G, Daikeler T, Woischnig AK, Martinez AE, Leuzinger K, Hirsch HH, Erlanger T, Wiencierz A, Bassetti S, Tamm M, Tschudin-Sutter S, Stoeckle M, Pargger H, Siegemund M, Boss R, Zimmer G, Vu DL, Kaiser L, Dell-Kuster S, Weisser M, Battegay M, Hostettler K, Khanna N. Ninety-day outcome of patients with severe COVID-19 treated with tocilizumab - a single centre cohort study. Swiss Med Wkly. 2021 Aug 10;151:w20550. doi: 10.4414/smw.2021.20550. eCollection 2021 Aug 2.
- Results publication: PubMed 38087481Seth-Smith H, Vesenbeckh S, Egli A, Ott S. SARS-CoV-2 in an immunocompromised host: convalescent plasma therapy and viral evolution elucidated by whole genome sequencing. BMJ Case Rep. 2023 Dec 9;16(12):e255255. doi: 10.1136/bcr-2023-255255.
- Results publication: PubMed 35630302Peter JK, Wegner F, Gsponer S, Helfenstein F, Roloff T, Tarnutzer R, Grosheintz K, Back M, Schaubhut C, Wagner S, Seth-Smith HMB, Scotton P, Redondo M, Beckmann C, Stadler T, Salzmann A, Kurth H, Leuzinger K, Bassetti S, Bingisser R, Siegemund M, Weisser M, Battegay M, Sutter ST, Lebrand A, Hirsch HH, Fuchs S, Egli A. SARS-CoV-2 Vaccine Alpha and Delta Variant Breakthrough Infections Are Rare and Mild but Can Happen Relatively Early after Vaccination. Microorganisms. 2022 Apr 21;10(5):857. doi: 10.3390/microorganisms10050857.
- Results publication: PubMed 35310621Bruningk SC, Klatt J, Stange M, Mari A, Brunner M, Roloff TC, Seth-Smith HMB, Schweitzer M, Leuzinger K, Sogaard KK, Albertos Torres D, Gensch A, Schlotterbeck AK, Nickel CH, Ritz N, Heininger U, Bielicki J, Rentsch K, Fuchs S, Bingisser R, Siegemund M, Pargger H, Ciardo D, Dubuis O, Buser A, Tschudin-Sutter S, Battegay M, Schneider-Sliwa R, Borgwardt KM, Hirsch HH, Egli A. Determinants of SARS-CoV-2 transmission to guide vaccination strategy in an urban area. Virus Evol. 2022 Mar 17;8(1):veac002. doi: 10.1093/ve/veac002. eCollection 2022.
- Derived from this study: PubMed 33740028Stange M, Mari A, Roloff T, Seth-Smith HM, Schweitzer M, Brunner M, Leuzinger K, Sogaard KK, Gensch A, Tschudin-Sutter S, Fuchs S, Bielicki J, Pargger H, Siegemund M, Nickel CH, Bingisser R, Osthoff M, Bassetti S, Schneider-Sliwa R, Battegay M, Hirsch HH, Egli A. SARS-CoV-2 outbreak in a tri-national urban area is dominated by a B.1 lineage variant linked to a mass gathering event. PLoS Pathog. 2021 Mar 19;17(3):e1009374. doi: 10.1371/journal.ppat.1009374. eCollection 2021 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Egli, Prof. Dr. med. principal investigator
Division of Clinical Bacteriology & Mycology, University Hospital Basel
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS Coronavirus (SARS-CoV-2) Infection, run by University Hospital, Basel, Switzerland at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no) (time frame: at baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351503, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.