Clinical trial NCT04351503: A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City; COVID-19
Official title: A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS Coronavirus (SARS-CoV-2) Infection
Keywords: Coronavirus Disease 2019 (COVID19)
SARS-CoV-2 re-infection
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: sciCORE University of Basel
name: Leonhard Med IT ETH Zurich
name: Swiss Institute of Bioinformatics
First posted: 2020-04-17
Enrollment: 126586
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)
timeFrame: at baseline
measure: duration of hospitalization (in days)
timeFrame: at baseline
measure: duration of Intensive Care Unit (ICU) stay (in days)
timeFrame: at baseline
measure: in-hospital mortality (binary, yes/no)
timeFrame: at baseline
measure: Number of infected cases within the city of Basel
timeFrame: at baseline
measure: whole genome sequencing to study pathogen evolution (number, type, and complexity of viral genome)
timeFrame: at baseline
measure: Identification which treatment modality is associated with adverse events (binary, yes/no)
timeFrame: at baseline
measure: Identification which treatment modality is associated with pulmonary recovery (binary, yes/no)
timeFrame: after 30 and 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
facility: Viollier AG
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Basel
country: Switzerland
facility: Biozentrum University of Basel
city: Basel
country: Switzerland
facility: sciCore University of Basel
city: Basel
country: Switzerland
facility: Department of Biosystems Science and Engineering ETH Zurich
city: Geneva
country: Switzerland
facility: Swiss Institute of Bioinformatics
Study officials:
affiliation: Division of Clinical Bacteriology & Mycology, University Hospital Basel
name: Adrian Egli, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bruningk 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.
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