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AGILE: Publications and Other Outputs

Publications

OutputTitleJournalDate PublishedPublication Link
CST6Development and validation of an LC-MS/MS method for quantification of favipiravir in human plasmaJournal of Pharmaceutical and Biomedical Analysis05 September 2023Read More
CST2Characterisation of SARS-CoV-2 genomic variations in response to molnupiravir treatment in the AGILE Phase IIa clinical trialNature Communications26 November 2022Read More
CST2A Randomised -Controlled Phase 2 trial of Molnupiravir in Unvaccinated and Vaccinated Individuals with Early SARS-CoV-2The Lancet ID19 October 2022Read More
CST2Pharmacokinetics of ß-d-N4-hydroxycytidine, the active metabolite of prodrug molnupiravir, in non-plasma compartments of patients with SARS-CoV-2 infectionClinical Infectious Diseases10 March 2022Read More
CST3AAn open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2Clinical Pharmacology & Therapeutics26 October 2021Read More
CST2The 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 salivaJournal of Pharmaceutical and Biomedical Analysis02 September 2021Read more
PlatformPractical recommendations for implementing a Bayesian adaptive phase I design during a pandemicBMC Medical Research Methodology20 January 2022Read More
PlatformAGILE: 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 letterTrials26 July 2021Read More
CST2Optimal dose and safety of the novel oral anti-viral molnupiravir in patients with early SARS-CoV-2: a phase 1, dose-escalating, randomised controlled studyJournal of Antimicrobial Chemotherapy27 August 2021Read More
PlatformAGILE-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 trialTrials19 June 2020Read More

Conference Proceedings

OuputTitleConferenceDate PresentedLink
CST6Development, 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 Drugs11th – 13th September, 2023
CST8Saliva, nasal & tear PK of ritonavir-boosted nimatrelvir (Paxlovid) in combination with molnupiravir in patients with laboratory-confirmed COVID-19International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs11-13th September 2023
PlatformThe AGILE Platform: Accelerating phase I/II evaluation of SARS-CoV-2 antiviralsInternational Pandemic Sciences Conference10-11th July 2023
CST2Saliva, nasal & tear PK of EIDD-1931 in patients with COVID-19 receiving molnupiravirCROI 202115 February 2022
CST3AAn open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for treatment of COVID-19International Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs 2021. Oral20 September 2021Read More
CST2Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a phase 1, open-label, dose-escalating, randomised controlled studyInternational Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs 202120 September 2021Read More

Related Publications

TitleJournalDate PublishedPublication Link
Application of novel plasma separation filter cards for quantification of NRTI di/triphosphates in DBS using LC-MSBioanalysis09 June 2023Read More
Prescribing Nirmatrelvir-Ritonavir: how to recognise and manage drug-drug interactionsAnnals of Internal Medicine01 March 2022Read 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 Chemotherapy18 June 2021Read More
Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxisBritish Journal of Clinical Pharmacology21 October 2020Read More
Pharmacokinetic modelling to estimate intracellular favipriavir ribofuranosyl-5′-triphosphate exposure to support posology for SARS-CoV-2Journal of Antimicrobial Chemotherapy02 June 2021Read More
Antiviral activity of molnupiravir precursor NHC against SARS-CoV-2 variants of concern (VOCs) and its therapeutic window in a human lung cell modelPreprint24 November 2021Read 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 studyInternational 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-19International 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)

Abstract: SALIVA, NASAL & TEAR PK OF EIDD-1931 IN PATIENTS WITH COVID-19 RECEIVING MOLNUPIRAVIR (croiconference.org)