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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.

Covid-19

Research related to COVID-19

Update on the SOLIDARITY trial

by Oriol Manuel, coordinating investigator for Switzerland and the CTU Lausanne team, published on 12 June 2020

SOLIDARITY is a large international randomised clinical trial launched by the World Health Organization (WHO) and partners to help find an effective treatment for COVID-19. International enrolment officially started on 22 March 2020. As of 9 June, more than 3500 patients have been recruited in 35 countries, with over 400 participating hospitals. 

The trial has an adaptative design with initially five arms: four potential treatments given with the local standard of care (remdesivir, hydroxychloroquine, lopinavir/ritonavir and lopinavir/ritonavir + interferon beta) are compared to the local standard of care alone. Due to recent findings, there are currently discussions regarding the continuation of the hydroxychloroquine arm. In addition, there is the possibility of testing immunomodulatory drugs if enough evidence of a potential benefit is provided. 

Thanks to the tremendous work provided by the teams and a fast processing time by the authorities, Switzerland started enrolling patients on 21 April. Currently, the inclusion rate is very low according to the local epidemiology of the disease. The number of newly hospitalised patients has dramatically decreased over the past weeks. Overall, 42 patients have been screened and 11 patients have been enrolled at 17 participating hospitals: Lausanne (coordinating centre), Delémont, Fribourg, Geneva, Neuchâtel, Rennaz, Sion, Aarau (Kantonspital and Hirslanden), Baden, Basel, Bern (Inselspital and Lindenhofgruppe), Frauenfeld, Münsterlingen, Olten, and Solothurn.

The trial is funded in Switzerland by the Swiss National Science Foundation and the drugs are provided free of charge by the WHO, which is the international sponsor. The Lausanne University Hospital (CHUV) was mandated by the Federal Office of Public Health to be the representative of the sponsor in Switzerland and as the coordinating centre. The CTU Lausanne coordinates the implementation of the trial in Switzerland. The CTU Lausanne and the CTU Bern jointly monitor the trial in Switzerland. The CTU Bern has additionally been mandated by the WHO to be the global central data monitoring centre of the trial.

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How are the Clinical Trial Units of our network involved?

All Clinical Trial Units (CTUs) at our member institutions are currently working at full speed to support research activities related to the COVID-19 outbreak. Some of the CTUs are involved in supporting international COVID-related research projects. All other research activities have been put on hold as far as possible.


Patient care comes first

CTUs may have to prioritise and reallocate resources in order to help researchers who are addressing this urgent situation. Furthermore, CTUs may have to redirect staff in order to support other activities in the hospitals, e.g. clinical care or administrative work.


Questions about ongoing research projects

CTU staff are available to answer questions about how to manage your ongoing projects. Additionally, Swissmedic and swissethics have prepared a joint document describing the most important recommendations for the treatment of patients in clinical trials of medicinal products. For the current version of the "Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic" see www.swissmedic.ch.

Researchers interested in conducting studies on COVID-19 can contact their local CTU.

CTU 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 collaborating partners, please contact the DKF; specific information can be found at COVID-19 research. As of 25 May 2020, 33 trials related to COVID-19 have been registered via this link. While 12 of these trials are already running, 21 have not yet started.

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 non-profit database with the evidence available worldwide on interventions for the prevention and treatment of COVID-19. This expanded database is continuously updated and freely available at COVID-evidence.org. COVID-evidence has recently received funding through the SNSF’s special call for projects on coronaviruses.

CTU Bern

Inselspital and the University of Bern collaborate closely with the universities of Basel, Zurich, Lausanne, and ETH Zurich. The CTU Bern is currently supporting a clinical trial that is still open and has patients with progressing COVID-19.

The CTU Bern also actively supports the WHO’s global SOLIDARITY trial and supports the CTU Lausanne in coordinating Swiss trial sites. Furthermore, the unit is involved in several local observational studies and a spatial epidemiology project that aims to map the distribution of COVID-19 cases in Switzerland.

CTU EOC

The CTU EOC is highly involved in coordinating and supporting COVID-19 trials. It is currently participating in two international and one national multicentre COVID-19 trials.

Furthermore, the CTU EOC is promoting, coordinating, and supporting seroprevalence and database studies related to COVID-19. A scientific committee, chaired by the CTU’s director, has been established to coordinate, evaluate, and prioritise research projects related to COVID-19.

CTU Geneva

The CTU Geneva is actively applying its expertise in the fight against COVID-19. The CTU supports international, national, and local COVID-19 trials and is involved in 25 trials related to COVID-19.

All of the CTU's resources are allocated to therapeutic clinical trials, cohort studies, or retrospective studies. The whole team, including nurses, physicians, pharmacists, clinical research associates, monitors, biostatisticians, data managers, and administrative staff, is collaborating with scientists to investigate COVID-19 infections and test the safety and efficacy of innovative treatments.

CTU Lausanne

A task force for research projects related to COVID-19 was set up to coordinate studies involving patients hospitalised at Lausanne University Hospital (CHUV), to ensure the practical feasibility of studies and investigations, and to avoid duplication. This internal institutional workgroup receives all proposals to involve COVID-19 patients at CHUV through the generic email address gt-recherche-covid@chuv.notexisting@nodomain.comch. At the beginning of June 2020, 70 research projects had been addressed. In addition, the task force receives requests from the local ethics committee CER-VD to evaluate research projects.

The SOLIDARITY consortium in Switzerland, coordinated by CHUV, includes 17 investigation sites. The CTU Lausanne, with the help of the CTU Bern, provides centralised coordination for Switzerland.

The CTU Lausanne also supports multiple other interventional and observational studies. To ensure proper data capture and handling for prospective and retrospective studies, the CTU set up an umbrella registry. This registry centralises structured routine data for clinical care analysis, clinical research status including informed consents status and enrolments, and dedicated research projects electronic case report forms (eCRFs).

With the approval of the cantonal EC, the CTU Lausanne developed numeric versions of information and consent forms on digital tablets during the COVID-19 crisis. This was done to replace paper for hospital hygiene reasons and to group the presentation of the studies, thus reducing the burden on patients.

CTU St.Gallen

The CTU St.Gallen is currently supporting a prospective cohort study about the incidence, spectrum of symptoms, and risk factors for COVID-19 among healthcare workers. This study is funded by the Swiss National Science Foundation. In addition, the CTU is involved in the Children's Hospital of Eastern Switzerland’s project called “Seroconversion for SARS-CoV-2 among co-workers of a children’s hospital”.

CTU Zurich

The University Hospital Zurich, in close collaboration with the EOC, started one of the first drug trials against COVID-19. In addition, the CTU Zurich is working 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, are combining their efforts to rapidly gain insight into mechanism and cell communication as the basis for future treatment and vaccine development. For this purpose, the CTU Zurich has recently established a biobank with COVID-2 samples and materials and is coordinating 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.


What is the role of the SCTO?

  • We regularly share the following information: updates relevant to the conduct of all clinical trials during the COVID-19 crisis, information on clinical research projects related to COVID-19, and other relevant news resulting from the COVID-19 crisis. Being part of the European Clinical Research Infrastructure Network (ECRIN) gives us access early on to pertinent information.

  • We support swissethics in their information activities by providing feedback from our network and giving practical input on their guidance documents.

  • We assist CTUs with COVID-19 applications in order to find national solutions for all activities.

  • We support adequate funding for COVID-19 initiatives, because especially services and preparatory work for large multinational trials have not been funded adequately – or at all – so far.

  • On a network level, we plan to use available cohort data to see how COVID-19 influences or has influenced other pathologies.

Photo by CDC on Unsplash