ECRAID-Prime

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, and intranasal saline compared with usual care, in patients 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 seven 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. 
 

Study locations

Primary care sites in: France, Germany, Belgium, Ireland, Poland, Spain, and the UK. 
Joining in Nov 2024: Georgia

Patient 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.
   

Patient exclusion criteria

The following patients 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 tumors, nasal masses, meningoencephalocele, and/or nasal surgery within 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.
   

Summary of trial procedure for patients 

Day 0: 

• First clinic visit: Patient’s first visit to the practice
• Informed consent: Obtain and review patient’s informed consent
• Collect information: Collect baseline information and contact details
• Swabs: Perform combined nasal and throat swabs
• Randomisation: Randomise the patient into a study group
• Study supplies: Provide study supplies to the patient
• Medication begins: Patient to begin using medication at home for 7 days

Days 1 – 28:

• Daily diary: Patient to record their daily symptoms, impact of symptoms, and healthcare utilisation in their diary.
• Days 4, 7 and 14 self-swabs: Patients to take a combined nose and throat swab at home.

Day 14:

• Phone call to patient: Check on safety issues and obtain a minimal set of outcome data 

Days 14 – 28:

• Contact patient: To arrange for collection of the swabs and leftover medication.
   

3-Month follow-up:

• Phone call to patient: Collect information about long-term consequences of the illness.
   

6-Month follow-up:

• Phone call to the patient: Collect information about long-term consequences of the illness.
   

Unscheduled calls, where needed:
•    Follow-up calls to patient: 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. 

Have a question? Get in touch with Coordinating Investigator Alike van der Velden at A.W.vanderVelden@umcutrecht.nl.