Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID04746183

AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 Treatment

Led by University of Liverpool · Updated on 2026-06-01

600

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Liverpool

Lead Sponsor

L

Liverpool School of Tropical Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating multiple potential treatments for adults with COVID-19 through the AGILE platform, which is a flexible, multi-center, multi-arm, adaptive phase I/II clinical trial. This trial tests various candidate drugs for safety, optimal dosing, and activity, allowing new candidates to be added or dropped efficiently based on emerging data. Promising treatments identified here may move on to larger phase II/III trials for further study. The trial includes several candidate-specific studies, each assessing different drugs such as EIDD-2801 (molnupiravir), Nitazoxanide, VIR-7831 and VIR-7832, intravenous Favipiravir, combinations of Molnupiravir and Paxlovid, and ALG-097558 alone or combined with remdesivir. Treatments are given orally or intravenously with dosing schedules varying by candidate, including multiple daily doses over several days. Some candidates are compared with placebo or standard care, and dosing is adjusted based on safety data. This design allows seamless transition from phase I dose-finding to phase II efficacy evaluation. Participants will be assessed through clinical evaluations, laboratory tests, and monitoring of viral loads and symptoms over periods ranging from 7 to 29 days after randomization. Safety is closely monitored by reviewing adverse events and vital signs, while efficacy is measured by changes in clinical status, viral clearance, hospitalization rates, and other COVID-19 related outcomes. Participants are expected to comply with study procedures and attend clinic visits throughout the treatment and follow-up periods.

CONDITIONS

Brief Title

AGILE (Early Phase Platform Trial for COVID-19)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with laboratory-confirmed SARS-CoV-2 infection (PCR)
  • Ability to provide informed consent personally or via a legally acceptable representative
  • Women of childbearing potential and sexually active men with such partners must agree to use highly effective contraception during and after the trial as specified
  • For severe disease group: hospitalized patients requiring oxygen or ventilation as defined by WHO severity scale
  • For mild to moderate disease group: ambulant or hospitalized patients with oxygen saturation above 94% on room air
  • Specific candidate trials may have additional criteria such as age 50 or 60 and above with controlled comorbidities, symptom onset within 5 days, good general health except for COVID-19, and household contact aged 16 or older
  • Willingness and ability to comply with study procedures and attend clinic visits throughout the trial
Not Eligible

You will not qualify if you...

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than 5 times the upper limit of normal
  • Stage 4 severe chronic kidney disease or dialysis requirement
  • Pregnant or breastfeeding
  • Expected transfer to a non-study hospital within 72 hours
  • Allergy to any study medication
  • Use of prohibited drugs within 30 days or five times their half-life before enrollment
  • Participation in another CTIMP trial
  • Prior COVID-19 infection or vaccination within 90 days (specific to some candidate trials)
  • Active liver disease or cirrhosis
  • Moderate to severe renal impairment or acute kidney injury
  • Swallowing difficulties
  • Receiving certain antiviral treatments or monoclonal antibodies at screening
  • Oxygen saturation below 94% on room air (with some exceptions)
  • Need for high-flow oxygen therapy, mechanical ventilation, or ECMO
  • Use of strong CYP450 3A4 inhibitors or inducers or sensitive substrates prior to dosing
  • Eligibility for other antiviral treatments per health criteria or other candidate trial participation as specified

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - Up to 7 to 11 days depending on the candidate

Participants receive initial dose-finding and safety assessment of the candidate drugs for COVID-19 treatment.

1 to 2 visits depending on cohort and dose escalation

Treatment

Duration - 5 to 14 days depending on treatment arm

Participants receive active treatment with candidate drugs or placebo as per their assigned cohort, with dosing schedules ranging from 5 to 14 days.

Daily or twice daily dosing with weekly or more frequent visits during treatment period

Follow-up

Duration - Up to 29 days from randomisation

Participants are monitored for safety, efficacy, and symptom resolution after treatment ends.

Multiple visits up to Day 29 post-randomisation

Trial Site Locations

Total: 7 locations

1

Desmond Tutu Health Foundation

Cape Town, South Africa

Completed

2

Ezintsha

Johannesburg, South Africa

Completed

3

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom, L7 8XP

Actively Recruiting

4

Kings College Hospital NHS Foundation Trust

London, United Kingdom

Active, Not Recruiting

5

Royal Free Hospital

London, United Kingdom

Actively Recruiting

6

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Actively Recruiting

7

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

H

Helen E Reynolds

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

21

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Published Research Related To This Trial

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.

Gareth Griffiths, Richard Fitzgerald, Thomas Jaki...

https://pubmed.ncbi.nlm.nih.gov/32560744

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.

Gareth O Griffiths, Richard FitzGerald, Thomas Jaki...

https://pubmed.ncbi.nlm.nih.gov/34311777

Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study.

Saye H Khoo, Richard Fitzgerald, Thomas Fletcher...

https://pubmed.ncbi.nlm.nih.gov/34450619

An Open Label, Adaptive, Phase 1 Trial of High-Dose Oral Nitazoxanide in Healthy Volunteers: An Antiviral Candidate for SARS-CoV-2.

Lauren E Walker, Richard FitzGerald, Geoffrey Saunders...

https://pubmed.ncbi.nlm.nih.gov/34699618

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.

Saye H Khoo, Richard FitzGerald, Geoffrey Saunders...

https://pubmed.ncbi.nlm.nih.gov/36272432

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.

Richard FitzGerald, Laura Dickinson, Laura Else...

https://pubmed.ncbi.nlm.nih.gov/35271729

Characterisation of SARS-CoV-2 genomic variation in response to molnupiravir treatment in the AGILE Phase IIa clinical trial.

I'ah Donovan-Banfield, Rebekah Penrice-Randal, Hannah Goldswain...

https://pubmed.ncbi.nlm.nih.gov/36435798