European Society of Endocrinology
COVID-19 and endocrine disease: Clinical information and comment from ESE
ESE and Endo-ERN launch an initiative to collect data on patients with rare endocrine conditions and COVID-19
The ESE Rare Disease Committee, alongside Endo-ERN, have engaged in an initiative to collect data concerning specific groups of patients with rare endocrine conditions, who are also affected by COVID-19. We believe this is a global unmet need and requires swift, concerted and coordinated action.
The European Registries for Rare Endocrine Conditions (EuRRECa) project, supported by both Endo-ERN and ESE, has developed an e-reporting tool (e-REC) which has been fully operational for over a year within a robust governance and ethical framework and which does not require individual patient consent. The platform is now open to all centres across the world to report a new confirmed or suspected case of COVID-19 in a patient with an existing endocrine or metabolic bone condition.
We would like to encourage you to join us in this important initiative by registering on the e-REC platform and begin submitting data. If you would like to use the e-REC platform to report a new COVID-19 infection in a patient with an existing condition, please visit the e-REC platform and create an account.
If you are already an active user of e-REC, then, after login, you will need to revise your reporting set up.
You can find out more about the functionality of e-REC in this recent report. If you need any assistance, please email the EuRRECa team.
EURORDIS-Rare Diseases Europe
EuRRECa
A number of e-REC users as well as others have approached the team to enquire whether the platform can be used to capture the occurrence of COVID19 infection in people with chronic conditions. Given that the e-REC platform can serve this purpose right now, an additional section has been added to capture the occurrence of a new COVID19 infection in a patient with an existing endocrine or bone condition.
If you are already an active user of e-REC, then after login, you will need to revise your reporting set up at e-REC. If you have an In Progress return you will need to submit it or delete it before you can change your reporting setup.
If you would like to use the e-REC platform, please visit e-REC and create an account.
Find further information here e-REC.
European Commission
Guidelines
COVID19-CMSS
ERNs support the fight against the COVID-19 infection: the European Commission has developed a web conferencing system for the clinical management of COVID-19 patients (COVID19-CMSS) that will support all EU hospitals treating complex COVID-19 cases by providing a communication mean to the treating clinicians.
The scope of the system is to focus exclusively on supporting clinicians in their daily practice.
The COVID19-CMSS web Conferencing system is aiming to allow clinicians to communicate easily with any other colleagues across the EU and EEA to exchange knowledge and to discuss cases as the gained clinical experience can represent an important contribution that could benefit hundreds of patients and healthcare professionals.
The COVID19-CMSS system consists of:
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- database of treating clinicians (the COVID-19 Clinicians Network) –currently under development–
- central helpdesk organising and managing the operation of the system
- communication tool for the web conferences (WebEx)
- simple and easy procedure and protocol to set Web conferences and Webinars following the request of any of the Hospitals identified as reference centres across the EU.
The creation of the COVID19-CMSS system has been communicated to the competent National authorities represented in the Health Security Committee of the EU including a list of all Hospitals members of ERNs and requesting contact details of clinicians interested in using the system. All the identified clinicians will receive the database of all the involved clinicians across the EU, including UK and Norway, along with the procedure for using the system. This will allow them to start immediately to request the support of ERN experts.
European Medicines Agency (EMA)
EU authorities published on 20th March 2020 the Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic, a recommendation to guide sponsors on how to manage clinical trials and their participants, given the impact of the COVID-19 pandemic on European health systems.
The guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine, access to public places (including hospitals) is limited due to the risk of spreading infections, and healthcare professionals are being reallocated. There is specific advice on the initiation of new clinical trials for treatments of COVID-19, and in particular on the need for large, multinational trial protocols.
Please check EMA’s website for further updates and consult also instructions regarding clinical trials issued by the national authorities (e.g. national Medicines Agencies) and hospitals.
COVID-19 paediatric clinical research
EMA’s Committee for Medicinal Products for Human Use (CHMP) recently published a call to pool EU research resources into large-scale, multi-centre, multi-arm clinical trials against COVID-19:
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- Larger trials should be prioritised over small studies or compassionate use programmes.
- Randomised controlled studies with a control arm without antivirals or other experimental agents should be prioritised.
- Multi-arm clinical trials investigating different agents simultaneously have the potential to deliver results as rapidly as possible.
- At least adolescent subjects should be considered for inclusion in the large adult clinical trials for COVID-19.
For CHMP press release click here.
The CHMP has provided recommendations on compassionate use of remdesivir for COVID-19:
Compassionate use as recommended by the CHMP refers to patients, including adolescents, with severe symptoms (ventilated/ECMO), includes adolescents:
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- Hospitalised with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) by Polymerase chain reaction (PCR) or known contact of confirmed case with syndrome consistent with COVID-19 with PCR pending
- Requiring invasive mechanical ventilation (e.g., via endotracheal intubation or tracheostomy)
- Adequate renal function with estimated glomerular filtration rate ≥ 30 ml/min by local laboratory measure
- ALT ≤ 5 x upper limit of normal (ULN) by local laboratory measure
Approved trials on COVID-19 open for patients < 18 years:
To date, only very few COVID-19 trials have been authorised for inclusion of paediatric patients, but the situation is fast evolving:
Public registries for trial information:
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- EU Clinical Trials Register (investigational trials approved in EU/EEA):
- ClinicalTrials.gov:
- EU PAS Register (call to researchers to register post authorisation studies):
- EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) encourage all researchers to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register. Researchers should include ‘COVID-19’ in the study title to allow easy retrieval of all COVID-19-related studies via the ‘Title of Study’ search filter. (The ‘Population Age’ filter can be applied to search for paediatric age groups.)
We recommend that any centres starting epidemiologic studies register them in the EU PAS register.
COVID-19 research support:
An overview of steps taken by EMA and EU regulators can be found here
European Journal of Endocrinology
