AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment
Lead Research Organisation:
University of Liverpool
Department Name: Pharmacology & Therapeutics
Abstract
Conventional evaluation of new medicines is too lengthy (typically 10 years) to meet the urgent need for treating and preventing COVID-19. Our challenge now is to accelerate this, to quickly identify which amongst the large and diverse list of new compounds and repurposed drugs (existing medicines used for treating other diseases) may be life-saving, and transformational.
Large-scale trials are currently evaluating the 'first wave' of repurposed medicines for treating COVID-19. Should these compounds fail to demonstrate benefit (such as has already occurred with candidates such as hydroxychloroquine, lopinavir, tocilizumab, sarilumab), a range of alternative, 'second wave' compounds (with less clinical evidence) have to be examined. Since a majority of experimental treatments which initially seem attractive will eventually prove ineffective, our best chance of finding an effective treatment lies in screening and choosing the most promising candidates as quickly possible. To do this, we need for a 'feeder' programme to advance plausible candidates for clinical evaluation, and to eliminate candidates with little or no prospect of clinical success.
AGILE is a platform for rapid clinical evaluation of potential COVID treatments. By harnessing modern statistical methods within an innovative trial design, we are able to make a seamless transition (for new compounds) from first-in-human use to finding the optimal dose for use in COVID patients. The trial is
i) Pragmatic - assessing outcomes in dozens (rather than hundreds) of patients
i) Adaptive - a small group of participants are initially enrolled, then (depending on safety) followed by further similar groups, with knowledge of safety, optimal dosing and efficacy accruing with each cycle.
ii) Statistically efficient - use of knowledge from 'control' COVID-19 patients within a statistical model allows multiple arms and interventions simultaneously or in sequence to be assessed. Drugs with little prospect of a moderate to significant effect are rapidly eliminated.
iv) Rapid and responsive - similar 'fast-track' programmes for cancer patients are approved by the UK regulator. Working closely with established consortia, AGILE will advance plausible candidates for these consortia to test in a large-scale trials.
Each new compound is included in a separate arm of AGILE. Innovative features of AGILE are the testing (for the first time in humans) in COVID-19 participants, the ability to tailor the study endpoints and participants to the anticipated deployment of the drug in real-life. This means that testing of antiviral drugs (a major focus of AGILE) takes place in community settings outside hospitals, and in people with mild-moderate disease since this is the scenario where these drugs are most likely to be used, to prevent severe disease, and reduce or prevent infections.
AGILE is designed to rapidly identify those compounds which could be game changers in in the battle against COVID19. To achieve this, we propose establishing a UK-wide network of AGILE sites to become a single, national platform for testing new COVID drugs. AGILE has full regulatory approvals, but is currently only operational in one UK site (Liverpool).
Large-scale trials are currently evaluating the 'first wave' of repurposed medicines for treating COVID-19. Should these compounds fail to demonstrate benefit (such as has already occurred with candidates such as hydroxychloroquine, lopinavir, tocilizumab, sarilumab), a range of alternative, 'second wave' compounds (with less clinical evidence) have to be examined. Since a majority of experimental treatments which initially seem attractive will eventually prove ineffective, our best chance of finding an effective treatment lies in screening and choosing the most promising candidates as quickly possible. To do this, we need for a 'feeder' programme to advance plausible candidates for clinical evaluation, and to eliminate candidates with little or no prospect of clinical success.
AGILE is a platform for rapid clinical evaluation of potential COVID treatments. By harnessing modern statistical methods within an innovative trial design, we are able to make a seamless transition (for new compounds) from first-in-human use to finding the optimal dose for use in COVID patients. The trial is
i) Pragmatic - assessing outcomes in dozens (rather than hundreds) of patients
i) Adaptive - a small group of participants are initially enrolled, then (depending on safety) followed by further similar groups, with knowledge of safety, optimal dosing and efficacy accruing with each cycle.
ii) Statistically efficient - use of knowledge from 'control' COVID-19 patients within a statistical model allows multiple arms and interventions simultaneously or in sequence to be assessed. Drugs with little prospect of a moderate to significant effect are rapidly eliminated.
iv) Rapid and responsive - similar 'fast-track' programmes for cancer patients are approved by the UK regulator. Working closely with established consortia, AGILE will advance plausible candidates for these consortia to test in a large-scale trials.
Each new compound is included in a separate arm of AGILE. Innovative features of AGILE are the testing (for the first time in humans) in COVID-19 participants, the ability to tailor the study endpoints and participants to the anticipated deployment of the drug in real-life. This means that testing of antiviral drugs (a major focus of AGILE) takes place in community settings outside hospitals, and in people with mild-moderate disease since this is the scenario where these drugs are most likely to be used, to prevent severe disease, and reduce or prevent infections.
AGILE is designed to rapidly identify those compounds which could be game changers in in the battle against COVID19. To achieve this, we propose establishing a UK-wide network of AGILE sites to become a single, national platform for testing new COVID drugs. AGILE has full regulatory approvals, but is currently only operational in one UK site (Liverpool).
Technical Summary
AGILE is a 'proof-of-confidence' engine designed to rapidly identify those compounds in phase I which could be game changers in the battle against COVID-19, validated to the point of readiness for onward inclusion into Phase IIb/III trials. Our vision is to build a single UK-wide phase I/IIa trial platform working to evaluate a strong portfolio of credible treatments, advancing only those most plausible compounds onwards. Unique features are the inclusion of COVID-19 patients from the outset (including first-into-human), statistically efficient trial design enabling rapid decisions, and ability to evaluate patients in the community as well as hospitals. Establishing this national early-phase trial platform will also advance preparedness for future epidemics of new viral diseases.
AGILE utilises a multi-candidate, multi-stage, Bayesian adaptive approach, and comprises a Master Protocol with each investigational compound included as a separate trial arms. AGILE is pragmatic (assessing outcomes in small numbers of patients), flexible (adopting primary endpoints appropriate to the action of each compound, with recruitment tuned to its anticipated therapeutic deployment) and seamless (progressing from first-into-human through dose optimisation to early efficacy evaluation). Staggered cohorts (each with 4 treatment, 2 controls) will be sequentially and flexibly added until the optimal dose is established, and thereafter for safety and efficacy evaluation. The adaptive design allows for i) discontinuation of a dose or candidate due to the probability of any promising effect being too low; ii) adding more participants at the same dose, or iii) recommending further evaluation in a late phase trial, through pre-defined stopping criteria for harm or futility. We have built strong links with UK Phase II/III platforms, the Global Therapeutics Accelerator, WHO and the PHE preclinical COVID19 drug screening platform which is in development.
AGILE utilises a multi-candidate, multi-stage, Bayesian adaptive approach, and comprises a Master Protocol with each investigational compound included as a separate trial arms. AGILE is pragmatic (assessing outcomes in small numbers of patients), flexible (adopting primary endpoints appropriate to the action of each compound, with recruitment tuned to its anticipated therapeutic deployment) and seamless (progressing from first-into-human through dose optimisation to early efficacy evaluation). Staggered cohorts (each with 4 treatment, 2 controls) will be sequentially and flexibly added until the optimal dose is established, and thereafter for safety and efficacy evaluation. The adaptive design allows for i) discontinuation of a dose or candidate due to the probability of any promising effect being too low; ii) adding more participants at the same dose, or iii) recommending further evaluation in a late phase trial, through pre-defined stopping criteria for harm or futility. We have built strong links with UK Phase II/III platforms, the Global Therapeutics Accelerator, WHO and the PHE preclinical COVID19 drug screening platform which is in development.
Publications
Pertinez H
(2021)
Pharmacokinetic modelling to estimate intracellular favipiravir ribofuranosyl-5'-triphosphate exposure to support posology for SARS-CoV-2.
in medRxiv : the preprint server for health sciences
Hiscox JA
(2021)
Shutting the gate before the horse has bolted: is it time for a conversation about SARS-CoV-2 and antiviral drug resistance?
in The Journal of antimicrobial chemotherapy
Pertinez H
(2021)
Pharmacokinetic modelling to estimate intracellular favipiravir ribofuranosyl-5'-triphosphate exposure to support posology for SARS-CoV-2.
in The Journal of antimicrobial chemotherapy
Amara A
(2021)
The development and validation of a novel LC-MS/MS method for the simultaneous quantification of Molnupiravir and its metabolite ß-d-N4-hydroxycytidine in human plasma and saliva.
in Journal of pharmaceutical and biomedical analysis
Rajoli RKR
(2021)
Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis.
in British journal of clinical pharmacology
Khoo SH
(2021)
Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study.
in The Journal of antimicrobial chemotherapy
FitzGerald R
(2022)
Pharmacokinetics of ß-d-N4-Hydroxycytidine, the Parent Nucleoside of Prodrug Molnupiravir, in Nonplasma Compartments of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection.
in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Donovan-Banfield I
(2022)
Characterisation of SARS-CoV-2 genomic variation in response to molnupiravir treatment in the AGILE Phase IIa clinical trial.
in Nature communications
Walker LE
(2022)
An Open Label, Adaptive, Phase 1 Trial of High-Dose Oral Nitazoxanide in Healthy Volunteers: An Antiviral Candidate for SARS-CoV-2.
in Clinical pharmacology and therapeutics
Marzolini C
(2022)
Fluvoxamine for the treatment of COVID-19.
in The Lancet. Global health
Ewings S
(2022)
Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic.
in BMC medical research methodology
Marzolini C
(2022)
Prescribing Nirmatrelvir-Ritonavir: How to Recognize and Manage Drug-Drug Interactions.
in Annals of internal medicine
Challenger E
(2023)
Development and validation of an LC-MS/MS method for quantification of favipiravir in human plasma
in Journal of Pharmaceutical and Biomedical Analysis
Khoo SH
(2023)
Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial.
in The Lancet. Infectious diseases
Title | AGILE Clinical Trial Platform |
Description | Infographic explaining how the AGILE clinical trial platform works |
Type Of Art | Film/Video/Animation |
Year Produced | 2021 |
Impact | The infographic is pubished on YouTube and has been used on the trial website and Twitter account. |
URL | https://youtu.be/n0-8Cw1d45U |
Title | AGILE Film 2 - Global Perspective |
Description | A short film describing the global perspective of the AGILE clinical trial platform |
Type Of Art | Film/Video/Animation |
Year Produced | 2022 |
Impact | The film is on the homepage of the AGILE trial website. It has had 262 views since it was published in February. |
URL | https://www.agiletrial.net |
Title | AGILE videos |
Description | A series of 9 videos describing various aspects of the AGILE clinical trial platform. |
Type Of Art | Film/Video/Animation |
Year Produced | 2022 |
Impact | Vidoes have been viewed by various people interested in the AGILE platform. |
URL | https://www.agiletrial.net/videos/ |
Title | High dose nitazoxanide joins the AGILE clinical trial platform |
Description | This is an infographic explaining the journey of nitazoxanide to join the AGILE clinical trial platform. |
Type Of Art | Film/Video/Animation |
Year Produced | 2021 |
Impact | The infographic is hosted on YouTube and has been used on the trial website and Twitter |
URL | https://youtu.be/bgXEOniY57Y |
Description | Assessing druGs for COVID19 In early cLinical phase Expeditiously (AGILE CST5) |
Amount | £3,200,793 (GBP) |
Organisation | GlaxoSmithKline (GSK) |
Department | GlaxoSmithKline, Stevenage |
Sector | Private |
Country | United Kingdom |
Start | 01/2021 |
End | 12/2022 |
Title | Bayesian dose-toxicity model |
Description | Utilised a novel Bayesian dose-toxicity model to accelerate early phase evaluatoon of experimental COVID therapies |
Type Of Material | Improvements to research infrastructure |
Year Produced | 2021 |
Provided To Others? | Yes |
Impact | delivery of 3 AGILE trials which have completed Phase I using this model - evaluating molnupiravir , high dose nitazoxanide and VIR7382 |
URL | https://pubmed.ncbi.nlm.nih.gov/34311777/ |
Description | AGILE SCTU |
Organisation | University of Southampton |
Department | University of Southampton Clinical Trials Unit |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | AGILE COnsortium led by University of Liverpool, Southampton CTU is a partner trials unit |
Collaborator Contribution | lead clinical trials unit |
Impact | 1: Khoo SH, Fitzgerald R, Fletcher T, Ewings S, Jaki T, Lyon R, Downs N, Walker L, Tansley-Hancock O, Greenhalf W, Woods C, Reynolds H, Marwood E, Mozgunov P, Adams E, Bullock K, Holman W, Bula MD, Gibney JL, Saunders G, Corkhill A, Hale C, Thorne K, Chiong J, Condie S, Pertinez H, Painter W, Wrixon E, Johnson L, Yeats S, Mallard K, Radford M, Fines K, Shaw V, Owen A, Lalloo DG, Jacobs M, Griffiths G. Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study. J Antimicrob Chemother. 2021 Nov 12;76(12):3286-3295. doi: 10.1093/jac/dkab318. PMID: 34450619; PMCID: PMC8598307. 2: Griffiths GO, FitzGerald R, Jaki T, Corkhill A, Reynolds H, Ewings S, Condie S, Tilt E, Johnson L, Radford M, Simpson C, Saunders G, Yeats S, Mozgunov P, Tansley-Hancock O, Martin K, Downs N, Eberhart I, Martin JWB, Goncalves C, Song A, Fletcher T, Byrne K, Lalloo DG, Owen A, Jacobs M, Walker L, Lyon R, Woods C, Gibney J, Chiong J, Chandiwana N, Jacob S, Lamorde M, Orrell C, Pirmohamed M, Khoo S; AGILE investigators. 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. 2021 Jul 26;22(1):487. doi: 10.1186/s13063-021-05458-4. PMID: 34311777; PMCID: PMC8311065. 3: Walker LE, FitzGerald R, Saunders G, Lyon R, Fisher M, Martin K, Eberhart I, Woods C, Ewings S, Hale C, Rajoli RKR, Else L, Dilly-Penchala S, Amara A, Lalloo DG, Jacobs M, Pertinez H, Hatchard P, Waugh R, Lawrence M, Johnson L, Fines K, Reynolds H, Rowland T, Crook R, Okenyi E, Byrne K, Mozgunov P, Jaki T, Khoo S, Owen A, Griffiths G, Fletcher TE; AGILE platform. An Open Label, Adaptive, Phase 1 Trial of High-Dose Oral Nitazoxanide in Healthy Volunteers: An Antiviral Candidate for SARS-CoV-2. Clin Pharmacol Ther. 2022 Mar;111(3):585-594. doi: 10.1002/cpt.2463. Epub 2021 Nov 13. PMID: 34699618; PMCID: PMC8653087. 4: Griffiths G, Fitzgerald R, Jaki T, Corkhill A, Marwood E, Reynolds H, Stanton L, Ewings S, Condie S, Wrixon E, Norton A, Radford M, Yeats S, Robertson J, Darby-Dowman R, Walker L, Khoo S; UK NIHR community. AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial. Trials. 2020 Jun 19;21(1):544. doi: 10.1186/s13063-020-04473-1. PMID: 32560744; PMCID: PMC7303573. |
Start Year | 2021 |
Description | GSK - AGILE CST5 |
Organisation | GlaxoSmithKline (GSK) |
Country | Global |
Sector | Private |
PI Contribution | GSK & Vir have funded AGILE CST5 first in human study of VIR 7832 |
Collaborator Contribution | We have developed a Uk Platform early phase trial for COVID therapeutics (AGILE). we conceived, developed and executed this early phase trial with industry support |
Impact | Phase I study completed, Phase II in progress Multidisciplinary, statisticians, Bayesian modellers, pharmacologists, clinical triallists, ID physicians, regulatory sciences |
Start Year | 2021 |
Title | A randomised, blinded Phase II trial of VIR7832 versus VIR7831 versus placebo |
Description | Phase II has now been completed and following data cleaning will be analysed. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2023 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
UKCRN/ISCTN Identifier | NCT04746183 |
Impact | Following analysis the data will be published. |
Title | An Open Label, Adaptive, Phase 1 Trial of VIR7832 in Healthy Volunteers |
Description | First in human study of VIR 7832, a novel monoclonal against SARS CoV2 |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2021 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
UKCRN/ISCTN Identifier | NCT04746183 |
Impact | utilised the Bayesian dose-toxicity model for accelerated decision making. |
Title | Phase I dose optimisation of novel COVID therapy - favipiravir |
Description | The phase I dose optimisation is currently ongoing |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2023 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
UKCRN/ISCTN Identifier | NCT04746183 |
Impact | The phase I dose optimisation is currently in progress. |
Title | Phase I dose optimisation of novel COVID therapy - high dose nitazoxanide |
Description | we completed and published our high dose nitazoxanide dose optimisation study for COVID |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2021 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
UKCRN/ISCTN Identifier | NCT04746183 |
Impact | PK characterisation of tizoxanide exposures. phase 2 study now in progress in S Africa following this study. |
URL | https://pubmed.ncbi.nlm.nih.gov/34699618/ |
Title | Phase I dose optimisation of novel COVID therapy - molnupiravir |
Description | we undertook Phase Ib dose optimisation of a new COVID Antiviral. The drug has since been licensed |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2021 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
Impact | drug has been licensed. wew were the first group to optimise dose for clinical evaluation |
Title | Phase I dose optimisation of novel COVID therapy - molnupiravir and Paxlovid combination |
Description | The phase I clinical trial is currently ongoing |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2023 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
UKCRN/ISCTN Identifier | NCT04746183 |
Impact | The Phase I clinical trial is ongoing. |
Title | Phase IIa evaluation of novel COVID therapy - molnupiravir |
Description | We have completed and published the Phase II trial of molnupiravir vs placebo in patients with COVID |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2022 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
UKCRN/ISCTN Identifier | NCT04746183 |
Impact | We found molnupiravir to be well tolerated and, although our predefined threshold was not reached, we observed some evidence that molnupiravir has antiviral activity in vaccinated and unvaccinated individuals infected with a broad range of SARS-CoV-2 variants, although this evidence is not conclusive. |
URL | https://doi.org/10.1016/S1473-3099(22)00644-2 |
Title | Phase Ib and Phase II study of novel COVID therapy - high dose nitazoxanide |
Description | High dose nitazoxanide safety and efficacy evaluation undertaken. |
Type | Therapeutic Intervention - Drug |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2023 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
UKCRN/ISCTN Identifier | NCT04746183 |
Impact | End of trial activities are currently ongoing which will include data analysis and publication. |
Description | A press release to announce Vir/GSK AGILE partnership by GSK (CST5) |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | Press release by Vir Biotechnology and GSK to announce that AGILE will evaluate VIR-7832 in the early treatment of COVID-19 (CST5) |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.gsk.com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-nhs-supported-agil... |
Description | AGILE website |
Form Of Engagement Activity | Engagement focused website, blog or social media channel |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | The AGILE trial website that hosts participant information for the public and health professionals, publications, and news about the AGILE trial platform. |
Year(s) Of Engagement Activity | 2021,2022,2023 |
URL | https://www.agiletrial.net/ |
Description | CGTN interview |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | Interview conducted by Emma Keeling for RAZOR on CGTN |
Year(s) Of Engagement Activity | 2022 |
URL | https://newseu.cgtn.com/news/2022-02-17/Could-antivirals-be-the-key-to-fighting-COVID-19--17xSyJl104... |
Description | Interview for Bloomberg News Hong Kong |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | CI Saye Khoo was interviewed by Bloomberg News Hong Kong about COVID and AGILE. |
Year(s) Of Engagement Activity | 2022 |
Description | Interview for German news |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | AGILE co-investigator Dr Richard FitzGerald was interviewed by RTL for a news broadcast about AGILE CST2 drug molnupiravir. |
Year(s) Of Engagement Activity | 2021 |
Description | Interview for Korean Breakfast Television |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | Interview with Saye Khoo about the AGILE Trial platform and it's impact on COVID treatment |
Year(s) Of Engagement Activity | 2021 |
Description | Interview for Nature |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Other audiences |
Results and Impact | A Nature news article was published following an interview with CI of AGILE Saye Khoo |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.nature.com/articles/d41586-021-00650-7 |
Description | Interview for Nature |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Interview by Nature for a news article with CI Saye Khoo about molnupiravir which is being studied in AGILE CST2. |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.nature.com/articles/d41586-021-02783-1 |
Description | Interview for international news |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | An interview with CI Saye Khoo by Bloomberg for a Businessweek feature about molnupiravir which is one of the drugs in the AGILE platform (CST2). |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.bloomberg.com/news/features/2021-03-25/merck-mrk-molnupiravir-pill-could-change-the-figh... |
Description | Interview for national news BBC broadcast |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Public/other audiences |
Results and Impact | Interview by Fergus Walsh, BBC News with Saye Khoo and featured the Liverpool CRF trial site following the licensing by the MHRA of the AGILE CST2 drug molnupiravir. |
Year(s) Of Engagement Activity | 2021 |
Description | Interview for regional ITV news |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Public/other audiences |
Results and Impact | An ITV local news broadcast, Granada Reports, article on evening news regarding dosing of patients with molnupiravir one of the AGILE platform drugs (CST2) at one of the AGILE platform sites. A website article was also published following the broadcast. |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.itv.com/news/2021-10-21/first-look-at-potential-covid-drug-that-could-help-most-vulnerab... |
Description | Interview for regional newspaper |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Public/other audiences |
Results and Impact | Interview with local PI, Chris Edwards and co-investigator Gareth Griffiths as Southampton CRF joined the AGILE platform for AGILE CST2 (molnupiravir). |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.dailyecho.co.uk/news/19833072.new-trial-covid-19-drug-launches-southampton/ |
Description | Interview for regional newspaper |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Public/other audiences |
Results and Impact | Co-investigator Gareth Griffiths was interviewed by the regional newspaper Southern Daily Echo to inform the general public about the AGILE clinical trials that are taking place, specifically about the trials taking place in Southampton. The aim was to increase awareness and increase trial participation. |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.dailyecho.co.uk/news/19004100.southampton-researchers-lead-trials-possible-covid-therapy... |
Description | Interview for web article |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | An interview with Saye Khoo by Wired about molnupiravir (AGILE CST2 drug) |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.wired.co.uk/article/merck-antiviral-resistance |
Description | Interview for web article |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Interview with C&EN for a discovery report entitled Antivirals for the Future |
Year(s) Of Engagement Activity | 2021 |
URL | https://cen.acs.org/sections/discovery-reports/antivirals-future-research-development-discovery-acut... |
Description | Interview with Chemical and Engineering News |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Interview with Chemical and Engineering News for an online article about Why antivirals are hard to develop. This interview took place shortly after the first participant was dosed with Vir-7832 in AGILE CST5. |
Year(s) Of Engagement Activity | 2021 |
URL | https://cen.acs.org/pharmaceuticals/drug-discovery/antiviral-drug-development-covid-19/99/i19 |
Description | Interview with Clinical Trials Arena |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | An interview with clinicaltrialsarena.com with CI Saye Khoo about the drug molnupiravir which is in AGILE CST2. |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.clinicaltrialsarena.com/analysis/molnupiravir-market/ |
Description | Interview with local radio |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Public/other audiences |
Results and Impact | AGILE co-investigator, Dr Richard FitzGerald was interviewed by Radio Merseyside and broadcast during the morning program. Molnupiravir (CST2) was the drug discussed. |
Year(s) Of Engagement Activity | 2021 |
Description | Interview with regional news (ITV Granada Reports) |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Public/other audiences |
Results and Impact | Local PI for AGILE CST2 was interviewed and broadcast on ITV Granada Reports following the licencing of AGILE CST2 drug molnupiravir by the MHRA. |
Year(s) Of Engagement Activity | 2021 |
Description | PPIE group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Reviewed trial Participant Information Leaflets and Consent Forms. |
Year(s) Of Engagement Activity | 2022 |
Description | Patient group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Routine meeting that included Participant Information Leaflet review training. Providing patient contributors with the skills and confidence to review PILs and other documents. |
Year(s) Of Engagement Activity | 2022 |
Description | Patient group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Tour of the NIHR Liverpool Clinical Research Facility followed by a meeting to discuss the trial platform and improving the patient recreation room. |
Year(s) Of Engagement Activity | 2023 |
Description | Patient group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Data privacy activity meeting. Review of the data privacy notice. Ensured that complex information is presented to participants and future participants in a meaningful and understandable way for all. Information sharing to enable the related activity to be conducted. |
Year(s) Of Engagement Activity | 2022 |
Description | Patient group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Review of CST8 trial participant facing documents and recruitment strategies. The outcome improved the documents which are now more acceptable to participants. |
Year(s) Of Engagement Activity | 2022 |
Description | Patient group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Introductory PPI Meeting. Introduction to the group, example of activities |
Year(s) Of Engagement Activity | 2022 |
Description | Patient group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Second introductory meeting. Introduction to the group, example of activities. |
Year(s) Of Engagement Activity | 2022 |
Description | Patient group meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | A second review of the CST8 trial participant facing documents. This improved the participant facing documents making them more acceptable to participants. |
Year(s) Of Engagement Activity | 2022 |
Description | Press release about CST2 Phase II (molnupriravir) results |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | A press release detailing the results of the Phase II clinical trial of molnupiravir following publication in The Lancet Infectious Diseases |
Year(s) Of Engagement Activity | 2022 |
URL | https://www.agiletrial.net/agile-trial-reports-on-antiviral-activity-of-molnupiravir-in-vaccinated-a... |
Description | Press release about first dose of Vir/GSK compound in AGILE CST5 |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | A press release to announce the first ever dose of Vir-7832 in humans in AGILE CST5. |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.agiletrial.net/first-patient-dosed-in-latest-stage-of-agile-covid-19-drug-trial/ |
Description | Press release by AGILE about Vir and GSK partnership (CST5) |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | Press release to announce the partnership with Vir and GSK for inclusion of an monoclonal antibody into the AGILE platform (CST5). |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.agiletrial.net/new-drug-joins-the-agile-trials/ |
Description | Press release to announce MRC funding |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | Press release to announce the MRC funding for AGILE |
Year(s) Of Engagement Activity | 2021 |
URL | https://www.agiletrial.net/government-funding-boost-for-covid-19-drug-testing-platform/ |
Description | Short Videos about the AGILE clinical trial platform |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | During 2021 we filmed different aspects of the AGILE clinical trial platform from which a suite of videos were produced. These are hosted on our website. |
Year(s) Of Engagement Activity | 2021,2022 |
URL | https://www.agiletrial.net/videos/ |
Description | Social media interactions via Facebook, Twitter, and Instagram |
Form Of Engagement Activity | Engagement focused website, blog or social media channel |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | Facebook, Twitter and Instagram accounts for AGILE have been established and are used as tools to share information about the clinical trials, recruitment and results. |
Year(s) Of Engagement Activity | 2022,2023 |
URL | https://twitter.com/LivAgile |
Description | YouTube video about COVID-19 pandemic in Liverpool |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | A YouTube video produced by the University of Liverpool about the COVID-19 pandemic and it's impact which included the AGILE clinical trial platform. |
Year(s) Of Engagement Activity | 2022 |
URL | https://www.youtube.com/watch?v=TB-6v15w930 |