SARS Coronavirus (SARS-CoV-2) Infection Clinical Trial
Official title:
A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City
| Verified date | May 2024 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study is to gain critical knowledge to understand the factors influencing the outcome of a pandemic virus within the city of Basel.
| Status | Completed |
| Enrollment | 126586 |
| Est. completion date | July 31, 2022 |
| Est. primary completion date | July 31, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Viollier AG | Allschwil | |
| Switzerland | Biozentrum University of Basel | Basel | |
| Switzerland | Department of Biosystems Science and Engineering ETH Zurich | Basel | |
| Switzerland | sciCore University of Basel | Basel | |
| Switzerland | University Hospital Basel | Basel | |
| Switzerland | Swiss Institute of Bioinformatics | Geneva |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | Leonhard Med IT ETH Zurich, sciCORE University of Basel, Swiss Institute of Bioinformatics |
Switzerland,
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, P — View Citation
Peter 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 — View Citation
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, H — View Citation
Seth-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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | at baseline | |
| Primary | duration of hospitalization (in days) | duration of hospitalization (in days) | at baseline | |
| Primary | duration of Intensive Care Unit (ICU) stay (in days) | duration of ICU stay (in days) | at baseline | |
| Primary | in-hospital mortality (binary, yes/no) | in-hospital mortality (binary, yes/no) | at baseline | |
| Primary | 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 | at baseline | |
| Primary | 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. | at baseline | |
| Primary | Identification which treatment modality is associated with adverse events (binary, yes/no) | Identification which treatment modality is associated with adverse events (binary, yes/no) | at baseline | |
| Primary | Identification which treatment modality is associated with pulmonary recovery (binary, yes/no) | Identification which treatment modality is associated with pulmonary recovery(binary, yes/no) | after 30 and 90 days |