ECRAID-Prime
European Clinical Research Alliance on Infectious Diseases - PRIMary care adaptive platform trial for pandemics and Epidemics
Background and Study Aims
Respiratory infections can be caused by SARS-CoV-2 (the virus that causes COVID-19), influenza, and other respiratory viruses and bacteria.
European citizens affected by COVID-19 have been well-served by landmark clinical trials in hospitals that have found treatments that save many lives. However, there are fewer opportunities for people in the community to contribute to the urgent mission of finding treatments for respiratory infections that speed recovery, and reduce the need for hospital admission in the first place.
ECRAID-Prime is an interventional trial that will be carried out across 12 countries, and will investigate the safety and efficacy of medical products to treat respiratory infections in adult patients across Europe in a primary care setting. It aims to find treatments that can help:
- speed up recovery;
- reduce the severity of symptoms;
- reduce hospital admissions;
- prevent the spread of viruses to family or household members.
As an "adaptive platform trial", ECRAID-Prime is intended to be a perpetually-renewing study with the flexibility to efficiently investigate and evaluate new treatments for respiratory infections on a continuous basis.
Further information about the trial and its aims can be found on ECRAID's central website:
Trial status: Recruiting
Contact Details
Oxford Email:
Participant Information Documents
What does the study involve?
Participating is easy. Your GP will take a combined throat/nose swab, which we can use to find out what is causing your respiratory infection.
If you participate, you will be randomised (allocated purely by chance) to receive:
- A medical product in addition to usual care.
- A control product in addition to usual care.
- The usual care alone.
Additionally, you will receive instructions on how and for how long to use the medical product (if you are randomised to receive one), combined throat/nose swabs to self-swab at day 4, 7, and 14, and a diary.
If you participate, you will be asked to:
- Take the medical product according to instructions (if you are randomised to receive a medical product.
- Complete the diary at the end of each day for 28 days.
- Take a combined throat/nose self-swab at day 4, 7, and 14, and store the swabs in your freezer.
- Answer questions by phone or online after 3 and 6 months.
Who can participate?
To be eligible to participate, you will need to be 18 years of age or older and experiencing symptoms of a respiratory infection such as runny nose, sore throat, cough, tiredness, headache and/or high temperature/fever with recent onset. We are currently recruiting at sites in France, Germany, Belgium, Ireland, Poland, Spain, and the UK.
What are the possible risks and benefits of participating?
Risks: The medical products may cause some side effects, which will be covered in the materials supplied with them. There may be also be some discomfort from self-administering the combined throat/nose swabs.
Benefits: Participants may benefit from the effects of any medical product they could be given. However, we do not yet know how well any of the products work; hence the need for this clinical trial. Nevertheless, even though taking part may not immediately benefit the participants, their participation will help researchers and doctors learn about the safety and any benefits of the medical products we are testing, thereby potentially enhancing the treatment of other patients with respiratory infections.
Trial Team
-
Ly-Mee Yu
Professor of Clinical Trials and Biostatistics
-
Nguyen Tran
Senior Trial Manager
-
Emma Harper
Trial Manager
-
Sarah Tonkin-Crine
Associate Professor & Health Psychologist
-
Fiona Mowbray
Qualitative Researcher
-
Jane Holmes
Medical Statistician
OXFORD CO-INVESTIGATOR
-
Chris Butler
Professor of Primary Care
EXTERNAL CO-INVESTIGATOR
Assistant Professor, University Medical Center Utrecht
Funding Details
European Union’s HORIZON 2021 – 2027 Research and Innovation Programme
Sponsored by University Medical Center Utrecht (UMCU) (Netherlands)
REC: 23/LO/0892
IRAS: 1008573
Registration: ISRCTN55471843
Related Publications
Patients’ and clinicians’ perspectives on the primary care consultations for acute respiratory infections during the first wave of the COVID-19 pandemic: an eight-country qualitative study in Europe
Marta Wanat, Melanie Eugenie Hoste, Nina Helene Gobat, Marilena Anastasaki, Femke Böhmer, Slawomir Chlabicz, Annelies Colliers, Karen Farrell, Sophie Hollerbach, Maria-Nefeli Karkana, John Kinsman, Christos Lionis, Ludmila Marcinowicz, Katrin Reinhardt, Ingmarie Skoglund, Pär-Daniel Sundvall, Akke Vellinga, Herman Goossens, Christopher C Butler, Alike van der Velden, Sibyl Anthierens, Sarah Tonkin-Crine