Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Platform randomised trial of treatments for COVID-19 in general practice

This study is for people in the UK who have COVID-19 symptoms, are managing their illness at home, and are more likely to have a difficult time with the virus. We are testing a medicine called Montelukast to see if it helps people recover faster. Participants will keep a daily diary to let us know when they feel completely better. We will also check if this medicine can help prevent people from needing to go to hospital, needing oxygen, or developing severe ongoing symptoms. By learning more, we hope to find better ways to help people recover from COVID-19 in the community.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Maastricht University

Enrolment target

682

Start

06 Mar 2023

Patients with symptomatic COVID-19 in the community and in primary care who are at higher risk of a complicated illness course.

What is this study about?

This research study is looking at treatments for COVID-19 for people who are unwell at home. We know that some people are more likely to become very ill with COVID-19, even if they're not in hospital. This study focuses on these individuals to find ways to help them recover faster and avoid serious complications.

The main goal of this study is to see if a medicine called Montelukast can help people with COVID-19 feel better sooner. Montelukast is a medicine that's already used for other health conditions, and in this study, we are exploring its effects on COVID-19 symptoms. We'll be asking participants to keep a simple daily record to tell us when they feel fully recovered.

Beyond how quickly people recover, we're also interested in whether this treatment can prevent other problems. This includes things like needing to go to hospital, getting oxygen, or ending up in intensive care. We also want to understand if it affects how severe symptoms are, how well people feel generally, and if it helps prevent long-lasting COVID-19 symptoms. Understanding these aspects will help doctors provide the best care for patients in the future.

Key takeaways

Tests Montelukast for COVID-19 recovery.
For adults at higher risk of severe illness at home.
Aims to speed up recovery and prevent hospitalisation.
Involves taking a tablet daily and keeping a simple diary.
Helps doctors understand better COVID-19 treatments for the community.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women can take part. To be eligible, you must have active symptoms of COVID-19 and be managing your illness at home, rather than being in hospital.

Crucially, you would also need to be considered at a higher risk of developing a more serious illness from COVID-19. Your doctor will be able to tell you if this applies to you, based on your health history. The study is designed for those who might need extra support to recover well.

It's important to remember that these are just the basic requirements. A doctor or research nurse would discuss all the details with you to make sure the study is suitable and safe for you to join.

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 over?
Do you currently have COVID-19 symptoms?
Are you managing your COVID-19 illness at home?
Has your doctor told you that you are at a higher risk of getting very unwell from COVID-19?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to take a tablet called Montelukast once a day. You would also need to keep a daily diary for 28 days. In this diary, you would simply answer 'yes' or 'no' to the question: 'Do you feel fully recovered today?' (meaning your COVID-19 symptoms are no longer causing problems).

Besides the daily diary, we would also check in with you to see how you are doing overall. We would ask about your symptoms, whether you've needed to contact health services, or if you've been to hospital. We would also be interested in your general well-being and any lasting symptoms. The total duration of active follow-up for diary entries is 28 days.

Potential risks and benefits

Taking part in this study could potentially help you recover more quickly from COVID-19 or reduce the chance of needing hospital care, although this is not guaranteed. As with any medicine, Montelukast can have side effects, which a doctor or study team member would fully explain to you beforehand. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is Montelukast and why is it being used?

Montelukast is a medicine primarily used for asthma and allergies. In this study, we're testing if it can also help people recover from COVID-19 symptoms more quickly and prevent serious illness.

How long will I need to take the medicine and keep a diary?

You would take the medicine once a day and record how you feel in a daily diary for up to 28 days.

What does 'higher risk of a complicated illness' mean?

This means you have certain health conditions or factors that might make you more likely to become very unwell with COVID-19. Your doctor can explain if this applies to you.

Will I know if I'm getting Montelukast or something else?

Because this is a research study, participants generally wouldn't know if they are receiving Montelukast or a placebo (a dummy pill). This helps us get accurate results.

What happens if I feel worse during the study?

If you feel worse at any point, you should contact the study team or your doctor immediately, just as you would normally do if you were unwell.