Actively Recruiting
AGILE (Early Phase Platform Trial for COVID-19)
Led by University of Liverpool · Updated on 2026-05-11
600
Participants Needed
7
Research Sites
317 weeks
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
The AGILE platform master protocol allows incorporation of a range of identified and yet-to-be-identified candidates as potential treatments for adults with COVID-19 into the trial. Candidates will be added into the trial via candidate-specific trial (CST) protocols of this master protocol as appendices. Having one master protocol ensures different candidates are evaluated in the same consistent manor and opening up new trials for new candidates is more efficient. Inclusion of new candidates will be based on pre-clinical data, evidence in the clinical setting and GMP capabilities.
CONDITIONS
Official Title
AGILE (Early Phase Platform Trial for COVID-19)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with laboratory-confirmed SARS-CoV-2 infection (PCR)
- Ability to provide informed consent by patient or legally acceptable representative
- Women of childbearing potential and sexually active men with such partners must agree to use highly effective contraception during treatment and for the specified duration after last dose
- For severe disease group: hospitalized patients with oxygen support or ventilation as defined by WHO severity scale
- For mild to moderate group: ambulant or hospitalized patients with oxygen saturation >94% on room air
- Specific CST criteria may include age 50 or 60 years and above with certain controlled comorbidities, symptom onset within 5 days, good general health except respiratory infection, and household contact aged 16 or older during dosing
- Willingness and ability to comply with study procedures and clinic visits
You will not qualify if you...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than 5 times upper limit of normal
- Stage 4 severe chronic kidney disease or dialysis
- Pregnant or breastfeeding women
- Expected transfer to non-study hospital within 72 hours
- Allergy to study medications
- Use of prohibited drugs within 30 days or five half-lives before enrollment
- Participation in another clinical trial of an investigational medicinal product
- Specific CST exclusions include prior COVID-19 infection or vaccination within 90 days, active liver disease or cirrhosis, severe renal impairment, swallowing difficulties, current use of certain antiviral or study drugs, low oxygen saturation below 94% on room air, urgent need for advanced respiratory support, and use of interacting medications such as strong CYP450 inhibitors or inducers
AI-Screening
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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
Research Team
H
Helen E Reynolds
CONTACT
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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