RecruitingPHASE1, PHASE2INTERVENTIONAL

AGILE (Early Phase Platform Trial for COVID-19)

The AGILE trial is a large study looking for new and effective ways to treat COVID-19. It acts like a testing ground, checking various experimental medicines (including some you might have heard of like Molnupiravir or Paxlovid) to see if they are safe and can help people recover from the virus. The trial is designed to be flexible, meaning researchers can quickly add new potential treatments as they emerge and remove others once they've been fully tested. This helps speed up the process of finding the best possible care for people with COVID-19, ensuring different treatments are all studied fairly and consistently.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Liverpool

Enrolment target

600

Start

03 Jul 2020

Estimated completion

31 Mar 2027

Covid19

What is this study about?

The AGILE trial is an important research study focused on finding better treatments for COVID-19. Think of it like a special research hub where many different, new medicines can be tested efficiently and fairly. The main goal is to figure out which of these medicines are safe for people to take, how much of the medicine is needed, and if they actually help people recover from COVID-19 and feel better.

What makes AGILE special is its flexible design. Instead of setting up a brand new study for every single potential medicine, AGILE has a main plan that allows different drugs to be added in as 'mini-trials' under one big umbrella. This means if scientists discover a new promising medicine for COVID-19, they can quickly start testing it within the AGILE framework. This approach helps researchers compare different treatments in a consistent way and speed up the process of finding effective options for patients.

Throughout the trial, researchers will carefully watch how safe each medicine is and if it shows any signs of working well. If a medicine looks promising in these early stages, it might then go on to be tested in even larger studies. This step-by-step approach ensures that only the most hopeful treatments move forward, eventually helping to improve treatment options for everyone affected by COVID-19.

Key takeaways

Aims to find new, effective COVID-19 treatments.
Tests multiple medicines in one flexible study.
Involves adults with confirmed COVID-19.
May involve new drugs, placebos, or standard care.
Participation includes tests and follow-up visits.
You can leave the study at any time.

Who may be eligible?

To join the AGILE study, you need to be an adult (18 years or older) and have a confirmed COVID-19 infection, usually by a PCR test. If you are female and could become pregnant, or a male partner of someone who could become pregnant, you'll need to agree to use effective contraception during and for a period after taking the trial treatment. You also need to be able to understand the study and agree to take part by signing a consent form.

Depending on which specific medicine is being tested, there might be further requirements. For example, some parts of the study might focus on people who are more severely ill and in hospital needing oxygen, while others might look at people with milder symptoms who are not as unwell. For certain medicines, there might also be age requirements – for instance, one part of the study looks for people aged 60 or older, or those aged 50 or older with certain other health conditions like heart disease or lung problems.

The research team will review all specific criteria carefully to make sure the study medicine is right for you. It's important to remember that these are general guidelines, and the team will discuss everything in detail with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed positive COVID-19 test (PCR)?
Are you willing to use effective contraception if needed?
Can you understand and agree to the study requirements?
Do you meet any specific age or health conditions for certain treatments (e.g., over 60, or over 50 with certain health issues)?

Answer every question to see your result.

What does participation involve?

Taking part in the AGILE trial involves testing a new or experimental medicine for COVID-19. You might receive the active study medicine or a 'placebo' (a dummy pill or treatment with no medicine in it), depending on the specific part of the trial you join. In some cases, you might receive the study medicine alongside the usual care for COVID-19 already provided by the NHS.

The trial involves several visits to a clinic or hospital, alongside assessments to check your health, how you're feeling, and any changes in your COVID-19 symptoms. This will include procedures like blood tests, checks of your vital signs (temperature, blood pressure), and possibly questionnaires. The specific number of visits, tests, and the total length of your participation will depend on which particular medicine is being studied and your health, but it could range from several weeks to a few months, with follow-up calls or visits after your main treatment period ends.

Potential risks and benefits

Taking part in this trial means you could potentially benefit from receiving a new treatment that might be more effective than existing options for COVID-19. However, there's no guarantee the medicine will help you, and it might not be better than standard care. Like all medicines, there's a risk of side effects, which could be mild or, in rare cases, more serious. The research team will explain all known side effects. You are free to withdraw from the trial at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Desmond Tutu Health Foundation
Verified postcode
Cape Town, South Africa· Completed
Ezintsha
Verified postcode
Johannesburg, South Africa· Completed
Liverpool University Hospitals NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom· Recruiting
Kings College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Active not recruiting
Royal Free Hospital
Verified postcode
London, United Kingdom· Recruiting
Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is the main goal of the AGILE trial?

The main goal is to find new and safe treatments that help people recover from COVID-19 more effectively.

Will I definitely get a new medicine if I join?

Not necessarily. You might receive the new medicine, a placebo (dummy treatment), or standard NHS care, depending on the specific part of the study.

How long will I be in the study?

The length of your participation will vary depending on the medicine being tested, but typically it involves several weeks to a few months of active participation and follow-up.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and your decision will not affect your standard medical care.

Who is funding this research?

While not explicitly stated in the provided text, trials like AGILE are often funded by government research bodies, medical charities, and pharmaceutical companies working together.

How to find out more

Helen E Reynolds

livagile@liv.ac.uk +44 (0)1517945553 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.