ECRAID-Prime
European Clinical Research Alliance on Infectious Diseases: Primary care adaptive platform trial for pandemics and epidemics.Study goal
This Phase 2B study aims to assess the efficacy of Nitric Oxide Nasal Spray (NONS) produced by SaNOtize, Canada, compared with intranasal saline spray, and intranasal saline spray compared with usual care, in participants with COVID-19 and COVID-like illness. Our goal is to determine whether these treatments can provide significant benefits in managing respiratory infection conditions and improving patient outcomes.
Current status
Full regulatory approvals have been obtained in eight countries across Europe. Site activation and patient recruitment are underway, with plans to expand to more countries in future. The target is to include 999 patients by the end of 2025. We are committed to advancing our research with additional therapeutics for a longer period of time, and will provide updates as the study progresses.
“It’s crucial to continue exploring effective and affordable therapeutics for respiratory viruses with a favourable safety profile, making them suitable treatment options for patients in primary and community care settings. With an approved adaptive platform trial and our European primary care research network, we’re advancing the fight against COVID and potentially future respiratory treats and strengthening Europe’s readiness for future outbreaks.”
– Alike van der Velden, Coordinating Investigator and Trial lead
Patient enrolment data
Participating countries
Here is a list of the research centres and clinics participating in the ECRAID-Prime NONs trial. The list will be expanded as additional countries join the trial.
| Country | Hospital |
| Belgium | University of Antwerp |
| France | CHU de Limoges |
| Germany | Universitätsklinikum Würzburg |
| Ireland | University College Dublin |
| Poland | Medical University of Białystok |
| Spain | IDIAP Jordi Gol - Unitat d'Estudis del Medicament |
| UK | Nuffield Department of Primary Care Health Sciences, University of Oxford |
| Georgia | Medcapital LLC |
Participant inclusion criteria
- ≥18 years of age.
- Presence of at least two symptoms suggestive of COVID-19 or COVID-like-illness.
- Onset of symptoms since 1 to 3 days.
- Willing and able to provide informed consent.
- Willing and able to comply with trial procedures.
- For women of child-bearing potential:
• A negative pregnancy urine test.
• Using an effective method of contraception or abstinence for 30 days before and after the days of trial medication administration.
Participant exclusion criteria
The following participants will be excluded from the study:
- Hospital admission: Requiring hospital admission on the day of screening or inclusion.
- Allergies: Known allergies or hypersensitivities to any of the components used in the formulation of the investigational product or control.
- Precluding conditions: Any disease, condition or disorder that would prevent participation in the trial.
- Upcoming surgery: Any planned major surgery within the next 28 days.
- Concurrent trials: Currently participating in a clinical trial involving an investigational product.
- Pregnancy/Breastfeeding: Known to be currently pregnant or breastfeeding.
- Epistaxis and hereditary conditions: Current or history of moderate to severe epistaxis or hereditary hemorrhagic telangiectasia.
- Cerebral spinal fluid leaks: History of cerebral spinal fluid leaks via the sinuses or nose.
- Nasal conditions/surgery: Nasal fracture, nasal tumours, nasal masses, meningoencephalocele, and/or nasal surgery in the past two weeks.
- Contraindicated agents: User of any of the contraindicated agents within seven days before screening. Speak to your doctor about any medications you use.
- G6PD deficiency: Known glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
How the trial works
Day 0:
- First clinic visit: Participant’s first visit to the practice
- Informed consent: Doctor or healthcare team obtains and reviews participant's informed consent
- Collect information: Doctor or healthcare team collects participant's baseline information and contact details
- Swabs: Doctor or healthcare team takes a throat/nose swab to determine the cause of participant's respiratory infection.
- Randomisation: Participant is randomly assigned into a study group
- Study supplies: Participant receives study supplies
- Medication begins: Participant begins using medication at home for 7 days
Days 1 – 28:
- Daily diary: Participant records their daily symptoms, impact of symptoms, and healthcare utilisation in their diary.
Days 4, 7 and 14:
- Participants to take a combined throat and nose swab at home.
Day 14:
- Phone call: Short call with the healthcare team to check in on participant's health.
Days 14 – 28:
- Contact with participant: To arrange for collection of the swabs and leftover medication.
3-Month follow-up:
- Phone call: Short call with the healthcare team to check in on participant's health and long-term consequences of the respiratory illness.
6-Month follow-up:
- Phone call: Short call with the healthcare team to check in on participant's health and long-term consequences of the respiratory illness.
Unscheduled calls, when necessary:
• Follow-up calls: In the event of (serious) adverse events (SAEs).
About ECRAID-Prime
ECRAID-Prime is one of the six projects funded by the European Commission's Horizon Europe program to drive therapeutic and vaccines clinical trials to boost COVID-19 treatment and prevention. It builds on many years of EU investment in infrastructure for primary care trials and a mature primary care research network that has pioneered novel, efficient, platform clinical trial designs. Read more on www.ecraid.eu/ecraid-prime.
EUCT nr: 2022-501707-27
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