Skip to main content Skip to footer

Agile CST-5


Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment

Candidate-Specific Trial 5 (CST-5): A Randomized, Multicentre, Seamless, Adaptive, Phase I/II Platform Study to Determine the Phase II dose of VIR-7832, and Evaluate the Safety and Efficacy of VIR-7831 and VIR-7832 for the Treatment of COVID-19


Phase I of this study will comprise a first-time-in-human dose-escalation phase for VIR-7832 in which subjects will be randomized to VIR-7832 or placebo in a 3:1 allocation ratio.

Each of these cohorts will be double-blind and blinded safety data will be reviewed between cohorts by a Safety Review Committee (SRC). Once a suitable dose is identified, VIR-7832 will progress to phase II, which will examine VIR-7832, VIR-7831 and placebo in a 2:2:1 ratio. The primary aim of this study is to assess the safety, tolerability and virological efficacy of VIR-7832 compared with placebo.


Primary Objectives

Phase I:

∙ To determine the safety and tolerability of single doses of VIR-7832, to aid dose selection for Phase II

Phase II:

∙ To investigate the effect of VIR-7832 compared with placebo on SARS-CoV-2 viral load

Secondary Objectives

Phase I:

∙ To characterise the Pharmacokinetics (PK) of single doses of VIR-7832

Phase II:

∙ Safety Objective: To determine the safety and tolerability of single doses of VIR-7832 and VIR-7831

∙ To characterise the PK of single doses of VIR-7832 and VIR-7831

∙ To investigate the effect of VIR-7832 and VIR-7831, both compared with placebo, on SARS-CoV-2 viral load over time

∙ Clinical Objective: To evaluate time to, and proportion of patients with clinical improvement

Exploratory Objectives

Phase I:

∙ To investigate the exposure-response relationship of the VIR-7832-mediated effect on SARS-Cov-2 viral dynamics

Phase II:

∙ To compare the effect of VIR-7832 versus VIR-7831 on T-cell responses to SARS-CoV-2

∙ To investigate the clinical efficacy of VIR-7832

∙ To monitor for SARS-CoV-2 resistance mutations against VIR-7831 and VIR-7832

∙ To evaluate the effect of VIR-7832 and VIR-7831 versus placebo on potential biomarkers of host response to SARS-CoV-2

Trial Design

3:1 randomised, blinded, placebo-controlled phase I of VIR-7832, followed by a 2:2:1 blinded, parallel group Phase II trial of VIR-7832 versus VIR-7831 versus placebo. A phase I will be carried out to test the safety and tolerability of VIR-7832 in this group. Following review of safety and tolerability data from evaluated doses of VIR-7832, a dose (of up to 500 mg) will be selected to progress to phase II. The selected dose of VIR-7832 will be further evaluated in a blinded, placebo -controlled randomised Phase II trial, which will assess the safety and virological efficacy of VIR-7832 and VIR-7831

Trial Status

Closed to recruitment. In follow-up.


Adult out-patients (≥18 years and ≤65 years in Phase I; ≥18 years in Phase II) with laboratory confirmed COVID-19 infection by positive polymerase chain reaction (PCR) test

Group B (mild-moderate disease) – as defined by master protocol

∙ Ambulant patients with peripheral capillary oxygen saturation (SpO2) >94% room air (RA), who have experienced symptoms of COVID-19 for <168 h (7 days)

Phase I: Variable, depending on dose escalation decisions, patients will be recruited into 3 cohorts of 8 patients.

Phase II: A maximum of 125 participants.

Senior Trial Manager:

Nicky Downs

Trial Manager:


Clinical Data Coordinator:

Oliver Edwards

Clinical Trial Monitors:

Doriana Cellura

Tryphena Konala

Parys Hatchard (unblinded)

Contact information:

Email: [email protected]

SAE reporting: 

On AGILE Safety Database:

Email: [email protected]

All essential trial documentation for each CST are hosted on the main AGILE website.

Press releases, video clips and other external websites

(The Agile Team cannot accept responsibility for external websites)

AGILE website (press section) –

AGILE CST-5 opening

Hear from AGILE Principal Investigator for Southampton, Professor Christopher Edwards, on the opening of CST-5 in Southampton:

AGILE Launch – June 2020