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The SCTO is an independent organisation and is based on a joint initiative of the Swiss National Science Foundation and the Swiss Academy of Medical Sciences.

As of 2017, the SCTO is a research infrastructure of national importance funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation.

Swiss contribution to EU-funded research initiative EU-RESPONSE
Swiss participation in the international SOLIDARITY trial
How are the Clinical Trial Units of our network involved?
Overview of submitted clinical trials and research projects
Recommendations for the treatment of patients within clinical trials


EU Commission supports international clinical research network to treat COVID-19

An ambitious new EU-funded research initiative, EU-RESPONSE (EUropean RESearch and Preparedness netwOrk for pandemics and emerging iNfectious diseaSEs), has established a clinical research network to treat COVID-19 and other emerging infectious diseases. The Commission announced on 18 September 2020 that it will support the project with €15.7 million.

The EU-RESPONSE consortium, led by the Institut National de la Santé et de la Recherche Médicale (INSERM), brings together 21 partners with world-class research capabilities from 13 EU countries, Norway, Switzerland, and Turkey to build a European network for adaptive platform trials (APTs) for COVID-19 and emerging infectious diseases. APTs have an innovative randomised controlled trial design, which enables various therapies for a disease to be studied simultaneously.

The SCTO is the project partner for Switzerland through its observer status in the European Clinical Research Infrastructure Network (ECRIN) that will play a role in the realisation of the project’s key objectives.

Read more about the project EU-RESPONSE:

Updated on 10 November 2021

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SolidAct

The EU-SolidAct trial is an adaptive platform trial that is part of EU-RESPONSE. The master protocol was developed for evaluating treatments in hospitalised patients with COVID-19, the disease caused by the SARS-CoV-2 virus (coronavirus).

While the master protocol is currently designed to test medications in hospitalised patients in phase 3 clinical trials, it will be expanded to other interventions and trial phases and will involve patients outside of hospital when necessary. The protocol is designed to function as the basis of a joint European response to combat infectious agents both now and in the future. The sub-protocol Bari-SolidAct has been added as a study arm.

Bari-SolidAct has now begun recruiting patients in Norway, France, Italy, and Spain (a total of 47 patients). Ireland, Slovakia, the Czech Republic, Luxembourg, Belgium, and Hungary are planning kick-offs. Switzerland is considering participating with two sites. The trial is sponsored by Oslo University Hospital in Norway.

The Bari-SolidAct trial is looking to see whether adding a well-known, anti-inflammatory drug for arthritis called baricitinib (often called by its brand name Olumiant) to state-of-the-art treatment can help people who have been hospitalised with severe SARS-CoV-2 to recover.

Added on 23 September 2021

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Swiss participation in the international SOLIDARITY trial

SOLIDARITY is an international clinical trial to help find an effective treatment for COVID-19 launched by the World Health Organization (WHO) and its partners. In Switzerland, 17 hospital centres are involved in the trial; the Lausanne University Hospital’s Clinical Trial Unit coordinates their involvement.

An update on the latest developments is available further below in our COVID-19 section How are the Clinical Trial Units of our network involved?


How are the Clinical Trial Units in our network involved?

Since March 2020, all Clinical Trial Units (CTUs) at our member institutions have been supporting research activities related to the COVID-19 outbreak. Some of the CTUs are involved in supporting international COVID-related research projects.

Patient care comes first
CTUs have needed – and might continue – to prioritise and reallocate resources in order to help researchers who are addressing this urgent situation. This can include redirecting staff in order to support other activities in the hospitals, for example clinical care or administrative work.

Questions about ongoing research projects
CTU staff are available to answer questions about how to manage your ongoing projects. Researchers interested in conducting studies on COVID-19 can contact their local CTU.

See also our COVID-19 sections Recommendations for the treatment of patients within clinical trials and Overview of submitted clinical trials and research projects

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DKF Basel

The Department of Clinical Research (DKF) offers coordinative and practical support. In addition, local research activities are registered at the DKF. If you would like to learn more about the DKF’s partners, please contact the DKF. Specific information on COVID-19 research projects at the University Hospital Basel can be found at COVID-19 research. As of 14 September 2021, 41 trials related to COVID-19 have been registered at the University Hospital Basel. While 3 of these trials have been completed, 18 are still ongoing, and 20 are in planning. Out of the 20 planned trials, 8 have already received approval from the ethics committee.

The DKF also initiated a joint project with the Meta-Research Innovation Center at Stanford (USA) and other international partners to create COVID-evidence, a freely-available database with evidence available worldwide on interventions for the prevention and treatment of COVID-19. This expanded database is continually updated and freely available at COVID-evidence.org. COVID-evidence has received funding through the SNSF’s special call for projects on coronaviruses.

CTU Bern

The CTU Bern actively supports the WHO’s global SOLIDARITY PLUS trial and helps the CRC Lausanne coordinate Swiss trial sites. Furthermore, the unit provides data management and statistical support to the planned WHO SOLIDARITY VACCINE trial. The CTU Bern is also involved in several local observational studies and a spatial epidemiology project that aims to map the distribution of COVID-19 cases in Switzerland. In addition, the CTU Bern is the national coordinator of the VACCELERATE research network.

CTU-EOC Lugano

The CTU-EOC is currently promoting, coordinating, and supporting seroprevalence, cellular immunity, and vaccine studies with repeated time points on healthcare workers, specific groups of patients, and the general population.

CRC Geneva

The CRC Geneva is actively applying its expertise in the fight against COVID-19. It supports international, national, and local COVID-19 trials and has been involved in 33 trials related to COVID-19 since February 2020.

Today, some of the CRC's resources are still allocated to therapeutic clinical trials, cohort studies, or retrospective studies. Nurses, physicians, pharmacists, clinical research associates, monitors, biostatisticians, data managers, and administrative staff are collaborating with scientists to investigate COVID-19 infections and test the safety and efficacy of innovative treatments.

CRC Lausanne

Following the impact of the first wave, non-COVID-19-related research activities at Lausanne University Hospital (CHUV) that were temporarily put on hold were progressively restarted and came back to full speed by the end of 2020. COVID-19-related research has continued – depending on study advancement and completion – in addition to the usual workload. Thus, the overall volume of clinical research activities remains at a high level.

The CRC Lausanne continues to support interventional and observational studies related to the pandemic. Overall, we have provided various levels of service to support 40 monocentric and multicentric studies. Most interventional trials are now completed; nevertheless, we are still involved in some of them, for example for a first-in-human experimental vaccine.

In addition, the CRC Lausanne continues its coordination for the SOLIDARITY trial consortium in Switzerland. In December 2020, the WHO published the interim results of this international study in the The New England Journal of Medicine (NEJM) (see link to article below). More than 11,000 patients were included in the study at that point in time. The repurposed antiviral drugs tested (remdesivir, hydroxychloroquine, lopinavir, and interferon) demonstrated little or no effect on hospitalised COVID-19 patients, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. An amendment to the protocol was submitted to the authorities in autumn 2020 to modify the tested treatments and add an immunomodulator drug (acalabrutinib) as a new intervention arm. However, this amendment could never be implemented since the ineffectiveness of this drug had been demonstrated in other studies in the meantime. Remdesivir allocation continued until the end of 2020 in order to close the debate on its efficacy. The decision to formally discontinue the remdesivir arm was taken in January 2021. The publication of SOLIDARITY’s final results on remdesivir is pending. In parallel, the WHO has evaluated the possibility of testing other immunomodulatory drugs, especially monoclonal antibodies. The new SOLIDARITY PLUS trial protocol will internationally evaluate three new treatments arms: artesunate, infliximab, and imatinib. Swissmedic has already approved the amended protocol, which is restricted to the use of infliximab and imatinib. The CRC is currently in the final organisational phase to resume inclusions in Switzerland.

Link to article on NEJM’s website, published on 2 December 2020:
Repurposed antiviral drugs for COVID-19 – interim WHO SOLIDARITY trial results
Link to WHO's website with frequent international updates on SOLIDARITY:
SOLIDARITY clinical trial for COVID-19 treatments

CTU St.Gallen

The CTU of St. Gallen’s cantonal hospital is currently supporting a prospective cohort study about the burden of COVID-19 in 59 long-term care facilities in St. Gallen and Vaud and the possible predictors of COVID-19 incidence in these facilities. This study is funded by the participating cantons and institutions. The CTU is also involved in a retrospective study comparing imaging features of chest CTs between COVID-19 patients and patients with COVID-19-associated pulmonary aspergillosis. Finally, the CTU is supporting two prospective observational studies at St. Gallen’s cantonal hospital examining the retinal endothelial function in patients with COVID-19 as well as risk factors for and the natural course of long COVID.

CTC Zürich

The University Hospital Zurich, in close collaboration with the EOC, started one of the first drug trials against COVID-19. In addition, the CTC Zurich has worked closely with the Infectiology Department to track and coordinate all COVID projects, clinical and other, to minimise the burden on patients.

Furthermore, the University Hospital Zurich partnered closely with Zurich’s blood donation centre BSZ and the Institute of Medical Virology (IMV) to start the first clinical trial to evaluate passive immunisation of high-risk patients with SARS-CoV-2 using plasma from recovered donors. The Angiology Department initiated the first multicentre clinical trial to validate the use of anti-coagulation in non-hospitalised patients with COVID in an outpatient setting across all five Swiss university hospitals.

Members of the research community across all universities on the University of Zurich’s campus, including the ETH, UZH, and USZ, combined their efforts to rapidly gain insight into mechanism and cell communication as the basis for future treatment and vaccine development. For this purpose, the CTC Zurich established a biobank with SARS-CoV-2 / COVID-19 samples and materials and coordinated the informed consent process for COVID patients. This growing sample collection serves as a bio resource for both the current and future needs of COVID researchers in the medical and scientific communities.


Updated on 10 November 2021


Overview of submitted clinical trials and research projects

COVID-19 project registry
The Swiss National Science Foundation’s (SNSF) COVID-19 project database provides the public with an overview of the of research on COVID-19 that is funded by the SNSF or Innosuisse or is within the European Framework programme Horizon 2020 with Swiss participation.

Link to the SNSF’s website:
Covid-19 Project Registry

 

Clinical trials and research projects
A list of submitted, but not yet approved, clinical trials and research projects on COVID-19 in Switzerland is available on the website of the Swiss Association of Research Ethics Committees (swissethics).

Link to swissethics’ website:
List of submitted, but not yet approved, clinical trials and research projects on COVID-19 in Switzerland


Recommendations for the treatment of patients within clinical trials

Swissmedic and swissethics published a joint document which describes the most important recommendations for the treatment of patients in clinical trials of medicinal products. For the current version, visit Swissmedic’s website:

Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic

 

 

Photo by CDC on Unsplash