AGILE: Publications and Other Outputs
Publications
| Output | Title | Journal | Date Published | Publication Link |
| CST6 | Development and validation of an LC-MS/MS method for quantification of favipiravir in human plasma | Journal of Pharmaceutical and Biomedical Analysis | 05 September 2023 | Read More |
| CST2 | Characterisation of SARS-CoV-2 genomic variations in response to molnupiravir treatment in the AGILE Phase IIa clinical trial | Nature Communications | 26 November 2022 | Read More |
| CST2 | A Randomised -Controlled Phase 2 trial of Molnupiravir in Unvaccinated and Vaccinated Individuals with Early SARS-CoV-2 | The Lancet ID | 19 October 2022 | Read More |
| CST2 | Pharmacokinetics of ß-d-N4-hydroxycytidine, the active metabolite of prodrug molnupiravir, in non-plasma compartments of patients with SARS-CoV-2 infection | Clinical Infectious Diseases | 10 March 2022 | Read More |
| CST3A | An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2 | Clinical Pharmacology & Therapeutics | 26 October 2021 | Read More |
| CST2 | 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 | Journal of Pharmaceutical and Biomedical Analysis | 02 September 2021 | Read more |
| Platform | Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic | BMC Medical Research Methodology | 20 January 2022 | Read More |
| Platform | 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 | 26 July 2021 | Read More |
| CST2 | Optimal dose and safety of the novel oral anti-viral molnupiravir in patients with early SARS-CoV-2: a phase 1, dose-escalating, randomised controlled study | Journal of Antimicrobial Chemotherapy | 27 August 2021 | Read More |
| Platform | 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 | 19 June 2020 | Read More |
Conference Proceedings
| Ouput | Title | Conference | Date Presented | Link |
| CST6 | Development, validation and application of a novel LC-MS method for quantification of favipiravir ribofuranosyl-5’-triphosphate (F-RTP) in human peripheral blood mononuclear cells (PBMCs) | International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs | 11th – 13th September, 2023 | |
| CST8 | Saliva, nasal & tear PK of ritonavir-boosted nimatrelvir (Paxlovid) in combination with molnupiravir in patients with laboratory-confirmed COVID-19 | International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs | 11-13th September 2023 | |
| Platform | The AGILE Platform: Accelerating phase I/II evaluation of SARS-CoV-2 antivirals | International Pandemic Sciences Conference | 10-11th July 2023 | |
| CST2 | Saliva, nasal & tear PK of EIDD-1931 in patients with COVID-19 receiving molnupiravir | CROI 2021 | 15 February 2022 | |
| CST3A | An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for treatment of COVID-19 | International Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs 2021. Oral | 20 September 2021 | Read More |
| CST2 | Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a phase 1, open-label, dose-escalating, randomised controlled study | International Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs 2021 | 20 September 2021 | Read More |
Related Publications
| Title | Journal | Date Published | Publication Link |
| Application of novel plasma separation filter cards for quantification of NRTI di/triphosphates in DBS using LC-MS | Bioanalysis | 09 June 2023 | Read More |
| Prescribing Nirmatrelvir-Ritonavir: how to recognise and manage drug-drug interactions | Annals of Internal Medicine | 01 March 2022 | Read More |
| Shutting the gate before the horse has bolted: is it time for a conversation about SARS-CoV-2 and antivrial drug resistance? | Journal of Antimicrobial Chemotherapy | 18 June 2021 | Read More |
| Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis | British Journal of Clinical Pharmacology | 21 October 2020 | Read More |
| Pharmacokinetic modelling to estimate intracellular favipriavir ribofuranosyl-5′-triphosphate exposure to support posology for SARS-CoV-2 | Journal of Antimicrobial Chemotherapy | 02 June 2021 | Read More |
| Antiviral activity of molnupiravir precursor NHC against SARS-CoV-2 variants of concern (VOCs) and its therapeutic window in a human lung cell model | Preprint | 24 November 2021 | Read More |
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
Characterisation of SARS-CoV-2 genomic variation in response to molnupiravir treatment in the AGILE Phase IIa clinical trial
An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2
Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic
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
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
Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study.
Shutting the gate before the horse has bolted: is it time for a conversation about SARS-CoV-2 and antiviral drug resistance?
Pharmacokinetic modelling to estimate intracellular favipiravir ribofuranosyl-5′-triphosphate exposure to support posology for SARS-CoV-2
Scalable nanoprecipitation of niclosamide and in vivo demonstration of long-acting delivery after intramuscular injection
COVID-19 chemotherapeutics without putting the cart before the horse
Toward Consensus on Correct Interpretation of Protein Binding in Plasma and Other Biological Matrices for COVID-19 Therapeutic Development
Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis
Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics
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
Pre-prints
Pharmacokinetics of ß-d-N4-hydroxycytidine, the active metabolite of prodrug molnupiravir, in non-plasma compartments of patients with SARS-CoV-2 infection
Evaluation of intranasal nafamostat or camostat for SARS-CoV-2 chemoprophylaxis in Syrian golden hamsters
Quantitation of tizoxanide in multiple matrices to support cell culture, animal and human research
Development of a highly sensitive bioanalytical assay for the quantification of favipiravir
Optimisation and validation of a sensitive bioanalytical method for Niclosamide
Conference Proceedings
Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a phase 1, open-label, dose-escalating, randomised controlled study. International Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs 2021
MEETING REPORT: Meeting Report Day 1 | S. Khoo | by M. Mascolini | AME academicmedicaleducation.com)
An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for treatment of COVID-19. International Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs 2021
MEETING REPORT: Meeting Report Day 1 | L. Walker | by M. Mascolini | AME (academicmedicaleducation.com)