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Griffiths, Gareth O., FitzGerald, Richard, Jaki, Thomas, Corkhill, Andrea, Reynolds, Helen, Ewings, Sean, Condie, Susannah, Tilt, Emma, Johnson, Lucy, Radford, Mike, Simpson, Catherine, Saunders, Geoffrey, Yeats, Sara, Mozgunov, Pavel, Tansley-Hancock, Olana, Martin, Karen, Downs, Nichola, Eberhart, Izabela, Martin, Jonathan W. B., Goncalves, Cristiana, Song, Anna, Fletcher, Tom, Byrne, Kelly, Lalloo, David 
ORCID: https://orcid.org/0000-0001-7680-2200, Owen, Andrew, Jacobs, Michael, Walker, Lauren, Lyon, Rebecca, Woods, Christie, Gibney, Jennifer, Chiong, Justin, Chandiwana, Nomathemba, Jacob, Shevin ORCID: https://orcid.org/0000-0003-2425-9394, Lamorde, Mohammed, Orrell, Catherine, Pirmohamed, Munir and Khoo, Saye
(2021)
'AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter'. Trials, Vol 22, Issue 1, p. 487.
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Abstract
Background
There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions.
Methods/design
AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol.
Discussion
Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment.
| Item Type: | Article |
|---|---|
| Subjects: | WB Practice of Medicine > WB 102.5 Clinical medicine - evidence-based practice WC Communicable Diseases > Virus Diseases > General Virus Diseases > WC 500 Virus diseases (General or not elsewhere classified) WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 505 Viral respiratory tract infections WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 506 COVID-19 |
| Faculty: Department: | Clinical Sciences & International Health > Clinical Sciences Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1186/s13063-021-05458-4 |
| Depositing User: | Stacy Murtagh |
| Date Deposited: | 19 Aug 2021 10:47 |
| Last Modified: | 03 Feb 2022 14:22 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/18696 |
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