2021/09 - Latest news from KCE Trials

September has been a busy month, as we had five submission deadlines in less than two weeks ! We’d like to thank all applicants and their CTU/CTC collaborators that submitted a study proposal or developed a study protocol.

We are also happy to share that results have been recently published for the Dawn Plasma study. It showed no effect of the intervention in recently hospitalized covid-19 patients, and therefore was able to provide a definite answer on that research question/treatment option.

KCE Trials team

Funding Opportunities

ALL CALLS ARE NOW CLOSED

All calls have been closed in September:

The investigator-led 2021 call: 20 proposals have been received
The commissioning call on Multiple Myeloma: 1 proposal has been received
The BeNeFIT-2 call: 8 outlines were developed as full protocols
The long Covid call: 5 outlines were developed as full protocols
The investigator-led 2020 call: 4 projects have been reworked based on comments from the last evaluation round

These proposals will now be thoroughly examined by our external advisory boards, and we will be able to get back to the applicants before the end of the year with an initial response.

Progress in funded studies

We are happy to announce the following important milestones have been reached in the trials below:

DAWN Plasma study Results published		The DAWN Plasma study investigated the impact of administering 4 units of plasma from cured covid-19 patients to hospitalized covid-19 patients. The Chief Investigator was Dr Geert Meyfroidt (UZ Leuven). Results showed no effect of this intervention. View the publication
DOMINO study Results presented and DOMINO app now publicly available		The DOMINO study recruited newly managed IBS (irritable bowel syndrome) patients in primary care and compared treatment with a musculotropic spasmolytic agent, otilonium bromide (OB), to a patient-administered dietary intervention. The study enrolled 483 patients The Chief Investigator of the study is Dr Jan Tack. Read more>> Results of the study were be presented during an online Symposium in April. You can stream the symposium here. The app “KU Leuven Domino Trial “ is now available and can be downloaded on Google Play or on the App store. It is recommended that patients discuss first with their GP before using this app.
HYFOIL study FPI		The first patient has been recruited in the HYFOIL study, investigating the impact on fertility after additional tubal flushing with oil-based contrast versus no additional flushing in infertile women. The Chief Investigator is Dr Diane De Neubourg (UZA). The study will recruit 736 patients from 12 hospitals, and is expected to last 4 years. Read more>>
IA-DUET study FPI		The first patient was randomised in Belgium in the IA-DUET study, investigating whether the survival in patients with a triazole susceptible Invasive Aspergillosis can be improved when the initial therapy consists of triazole and echinocandin combination therapy instead of triazole monotherapy, in the BCC, UZ Leuven by Prof Johan Maertens and his team, not long after the first patient was included at the Sponsor Institute Erasmus MC, Rotterdam by the CI Prof Bart Rijnders in July. The study will recruit 650 patients from 18 hospitals and is supported by HOVON and is expected to last 4 years. Read more >>
BigBird Database lock		The study completed the collection of the 12 month follow-up data and performed data base lock. Results are eagerly awaited towards the end of the year. Read more >>
KIWI study Abandoned		The CI/ Sponsor Prof Roger Damoiseaux, UMC Utrecht, and Belgian PI/ BCC Prof Ann Van den Bruel, UZ Leuven were disappointed to announce that the study ended prematurely due to difficulties in obtaining a suitable placebo inhaler. Read more >>

The KCE Trials complete portfolio comprises 35 studies. more info>>

Impact

The latest scientific publications are presented below, and all can be found on the last tab of our dynamic dashboards.

Results Dawn Plasma	August 2021	Early high antibody-titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma
Meta-Analysis using COVAID data	July 2021	Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19 - A Meta-analysis
Results OptiMEDs study	March 2021	Efficacy, feasibility and acceptability of the OptiMEDs tool for multidisciplinary medication review in nursing homes

NEWS
EQ-5D-5L value set for Belgium

The KCE has recently produced an EQ-5D-5L value set for Belgium, based on the preferences of a representative sample of the general public. The EQ-5D is a generic health-related quality of life (HRQoL) instrument, whose use is widespread in clinical research and explicitly encouraged by the Belgian guidelines for health economic evaluations. The value set assigns utilities to health states and allows e.g. to calculate QALYs gained with a health intervention. A two-page summary in Dutch or French highlights the key points of the value set, while detailed information can be found on the KCE website. A virtual meeting will be organized on 1 October 2021. Watch the KCE website for more information on this meeting.