Bionical Emas are providing full-service CRO support for a Phase 2 study to evaluate the safety and efficacy of an intranasal antibody in patients with asymptomatic or mild COVID-19 in the UK.
- Design a study to expedite the development of potential and much needed COVID-19 treatments.
- Working in an evolving and rapidly-changing COVID-19 landscape where cases appear in difficult to predict waves.
- Recruiting and treating an outpatient population of COVID-19 positive patients with asymptomatic or mild disease, that are not routinely seen in primary or secondary care in the UK.
|Trial Aspect||Traditional||Site-less DCT|
|Recruitment||Investigator and site team led||Self-referral via advertising|
|In-Person Protocol Visits||On-site||At the participant’s home|
|Telephone Protocol Visits||Via telephone||Via telephone or virtual call|
|ID Dispensing||IP distributed to site pharmacy, dispensed by site pharmacist||IP distributed direct-to-participant’s home by central dispensary|
|IP Delivery||Administered at the site||Administered in the participant’s home|
|Laboratory Assessments||Samples taken on-site and results available through a local or central laboratory depending on the same type||Samples taken a visit at the participant’s home, posted directly to the central laboratory and results available centrally|
|ePRO Completion||Participant completes at home on their own (or provisioned) device||Participant completes at home on their own (or provisioned) device|
|Investigator Oversight||Site-level on-site Investigator team||Study-level virtual Investigator team|
- Bionical Emas estimated a set-up of less than 6 weeks from final protocol to first patient in, and recruitment of 350 participants in a further 6 weeks. To date, Bionical Emas completed the writing of essential documents (protocol, IB, IMPD), completed early engagement with the MHRA on the study design, and have received full MHRA and REC approvals.
- A cost comparison of this site less design vs. a traditional site based model showed a 20% reduction in costs for the site-less design. Cost savings were predominantly due to shorter study timelines, particularly with regards to study start-up and recruitment.
- We welcome future opportunities to offer our expertise in the design of novel and decentralised clinical trials.