Agile CST-2
Candidate-Specific Trial 2 (CST-2) Title: A Randomized, Multicentre, Seamless, Adaptive, Phase I/II Platform Study to Determine the optimal dose, Safety and Efficacy of EIDD-2801 for the Treatment of COVID-19.
Open-label 2:1 randomised controlled phase I of EIDD-2801 versus standard of care followed by a 1:1 blinded controlled parallel group Phase II trial of EIDD-2801 versus placebo. A phase I will be carried out to confirm the optimal dose in this group. Following a safety review, EIDD-2801 will be tested for efficacy in a blinded placebo controlled randomised phase II trial.
- Safety Objective: To determine the safety and tolerability of multiple ascending doses of EIDD-2801.
- Efficacy Objective: To determine the ability of EIDD-2801 to reduce serious complications of COVID-19 including hospitalization, reduction in SaO2<92%, or death.
- Pharmacokinetic (PK) Objective: To define PK of EIDD-2801 and EIDD-1931 in plasma following multiple doses administered to patients with COVID-19.
- Virologic Objective: To assess the difference in viral clearance (time to negative PCR) between EIDD-2801 and control.
- Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients based on a patient reported outcome tool.
- Pharmacokinetic (PK) Objective: To define non-plasma PK of EIDD- 2801 and EIDD-1931 following multiple doses administered to patients with COVID-19 through samples of saliva, tears, dried blood spots and nasal swabs.
- Pharmacodynamic (PD) Objective: To characterise virus and host immune response through samples of serum and nose/throat swab.
Open-label 2:1 randomised controlled phase I of EIDD-2801 versus standard of care followed by a 1:1 blinded controlled parallel group Phase II trial of EIDD-2801 versus placebo.
A phase I will be carried out to confirm the optimal dose in this group. Following a safety review, EIDD-2801 will be tested for efficacy in a blinded placebo controlled randomised phase II trial. Phase Ib, EIDD-2801 will be administered orally, twice daily (BID) for 10 doses (5 or 6 days). The starting dose will be established based on safety and pharmacokinetics from the EIDD-2801-1001-US/UK study, and dose escalations may occur as described in this CST.
Phase II, As per Phase Ib, with the dose determined by the recommended phase II dose.
Closed
Adult out-patients (≥18 years) with laboratory-confirmed SARS-CoV-2 infection (PCR) who are within 5 days of symptom onset.
Trial Team
Senior Trial Manager:
Emma Knox
Trial Manager:
Calley Middleton
Contact Information
Email: [email protected]
SAE reporting:
Email: [email protected]
All essential trial documentation for each CST are hosted on the main AGILE website.
Saye H Khoo, Richard Fitzgerald, Thomas Fletcher, Sean Ewings, et al: Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a phase 1, dose-escalating, randomised controlled study. Journal of Antimicrobial Chemotherapy, Aug 2021, https://doi.org/10.1093/jac/dkab318
Press releases, video clips and other external websites
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AGILE website (press section) – https://www.agiletrial.net/for-press/