ECRAID-Prime

• Research type

  Research Study

• Full title

  European Clinical Research Alliance on Infectious Diseases - Primary care adaptive platform trial for pandemics and epidemics (ECRAID-Prime)

• IRAS ID

  1008573

• Contact name

  Christopher Butler

• Contact email

  christopher.butler@phc.ox.ac.uk

• Sponsor organisation

  University Medical Center Utrecht

• ISRCTN Number

  ISRCTN55471843

• Research summary

  ECRAID-Prime is a platform randomised, double-blind, multi-center, multi-country trial. The perpetual platform nature of ECRAID-Prime allows multiple treatments/interventions to be tested for the same illness simultaneously & new treatments/interventions to be added during the course of the trial. The master protocol describes the overall structure & processes of the platform, while specific information regarding treatments/interventions and comparators are described in separate intervention-specific appendices (ISAs).
  The rationale of ECRAID-Prime is to test the safety and efficacy of treatments/interventions for patients presenting to primary care with COVID-19 or COVID-19-like-illness in a phase II/III type evaluation. This helps determining whether treatments/interventions should progress to a next phase of evaluation. Using qualitative research methods, we will additionally assess the trial process and procedures in order to optimise them, with the aim to optimally streamline patient recruitment. The ultimate aim of ECRAID-Prime is to reduce illness duration, complications and possibly transmission of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza, respiratory syncytial virus (RVS) and other respiratory pathogens.
  ECRAID-Prime will start as a three-arm trial: 1) Usual Care (UC), 2) Nitric Oxide Nasal Spray (NONS) plus UC and 3) Saline plus UC. This allows us to compare NONS to its closest comparator, Saline nasal spray, and additionally to investigate the effect of frequently spraying Saline.
  Eligible are adults, presenting to primary care with at least two symptoms suggestive of a COVID-19 or COVID-19-like-illness, an onset of symptoms less than 3 days for the first comparisons, and confirmed by a medically qualified health care provider that the illness is due to a respiratory tract infection. A swab will be (self)-taken at baseline and subsequently self-taken on days 4, 7 and 14. The study duration for participnats is 6 months

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  23/LO/0892

• Date of REC Opinion

  19 Feb 2024

• REC opinion

  Further Information Favourable Opinion