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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled Phase 2 study using the rhinovirus challenge model to investigate the efficacy and safety of 2-Deoxy-D-glucose as pre-exposure prophylaxis.

This research study is looking at a new medicine, 2-Deoxy-D-glucose (2-DG), to see if it can protect people from catching the common cold, which is often caused by a virus called rhinovirus. We are hoping to find out if taking 2-DG before you are exposed to the cold virus can stop you from getting sick, or at least make your symptoms milder. To do this, some volunteers will receive 2-DG, while others will receive a dummy pill (placebo). We will then compare how many people in each group get sick and how severe their symptoms are. We'll also be carefully checking for any side effects to make sure the medicine is safe. This is a "Phase 2" study, which means we are still in the early stages of testing this new medicine.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
G.ST Antivirals GmbH, G.ST Antivirals GmbH
Enrolment target
128
Start
14 Feb 2024

What is this study about?

This study is about understanding if a new medicine, called 2-Deoxy-D-glucose (you can call it 2-DG for short), can help prevent common colds. Most common colds are caused by a type of virus called a rhinovirus. Think of 2-DG as a potential shield against these cold viruses.

We're testing 2-DG as a 'pre-exposure prophylaxis' – that's a fancy way of saying we want to see if taking the medicine *before* you might catch a cold can stop you from getting sick. To do this, we'll give some people 2-DG, and others will get a 'placebo' which looks exactly like the medicine but has no active ingredients. This helps us fairly compare if 2-DG actually works. We'll be carefully watching both groups to see if fewer people in the 2-DG group get sick, how bad their symptoms are, and how long their colds last.

It's important to know that this is a 'Phase 2' study. This means it's an early stage of testing for a new medicine. We are mainly focusing on finding out if 2-DG is safe and if it shows promise in preventing rhinovirus infections. If it looks good in this stage, it can move on to larger studies in the future. Your participation is really important because it helps scientists learn more and potentially develop new ways to tackle common colds.

Key takeaways

  • This study is testing an experimental medicine (2-DG) for common cold prevention.
  • It aims to see if 2-DG can stop rhinovirus (cold virus) infections.
  • Participants will receive either 2-DG or a dummy pill.
  • The study will track illness, symptoms, and safety.
  • It's a Phase 2 study, focused on early safety and effectiveness.
  • Participation helps scientists learn about potential new cold treatments.

Who may be eligible?

To be able to take part in this study, participants generally need to be adults, specifically 18 years old or older. There is no upper age limit, meaning older adults can also participate.

Both men and women are welcome to join this study. The researchers want to include a wide range of people to get a good understanding of how the medicine works.

While the basic requirements are simply being an adult, other factors that aren't mentioned here, like your general health and other medicines you might be taking, will also be checked by the study doctors to make sure the study is right and safe for 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.

  1. Are you 18 years old or older?
  2. Are you comfortable potentially taking an experimental medicine or a placebo?
  3. Are you able to attend regular study appointments?
  4. Are you willing to report any symptoms you experience accurately?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's a general idea of what to expect. You would first have some initial health checks to ensure you're suitable for the study. Once accepted, you would be given either the study medicine, 2-DG, or a dummy pill (placebo) to take. Neither you nor the study team will know which one you are taking until after the study is over.

The study would involve regular check-ups and assessments, which might include giving blood or nose swab samples to check for virus infection and to monitor your health. You'd also be asked to keep track of any symptoms you experience, like a runny nose or sore throat, and how severe they are. The total duration of your involvement, including taking the medicine and follow-up checks, would be explained in full detail by the study team, but typically, studies like this involve several visits over a period of weeks or months.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as contributing valuable information that could lead to new ways of preventing common colds. While we hope 2-DG might help prevent illness during the study, there's no guarantee it will work for you, especially if you receive the placebo. There are also potential risks, including side effects from the study medicine itself, or discomfort from procedures like blood tests. The study team will explain all known side effects. 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.
  • Unverified
    Netherlands

Common questions

What is the common cold virus this study is looking at?

The study is focusing on rhinovirus, which is the most common cause of the 'common cold'.

What does 'pre-exposure prophylaxis' mean?

It means taking the medicine *before* you might be exposed to the virus, hoping it will prevent you from getting sick.

Will I know if I'm getting the real medicine or a dummy pill?

No, neither you nor the doctors will know until after the study has finished. This is to make the results as fair as possible.

What kind of information will the study collect from me?

They will look at whether you get sick, how long your symptoms last, how severe they are, and check for any unexpected effects from the medicine.

What is a 'Phase 2' study?

It's an early stage of testing for new medicines, focusing on whether it's safe and shows promise in working against the illness.

How to find out more

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

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