Study on 2-Deoxy-D-Glucose for Preventing Common Cold in Healthy Adults

What is this study about?

This clinical trial is focused on studying the common cold, specifically illnesses caused by the rhinovirus. The trial will test a treatment called 2-deoxy-D-glucose, also known as 2-DG, which is administered as a nasal spray. The study will compare the effects of this treatment to a placebo to see if it can prevent illnesses associated with the rhinovirus.

The purpose of the study is to confirm whether 2-DG is effective in preventing rhinovirus-related illnesses. Participants in the study will be randomly assigned to receive either the 2-DG nasal spray or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results.

Throughout the study, participants will be monitored for any signs of illness and any side effects. The study will also track the number of people who get infected, the severity of symptoms, and how long the illness lasts. This information will help determine if 2-DG is a safe and effective way to prevent the common cold caused by the rhinovirus.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your willingness to participate.

You must be a healthy adult between the ages of 18 and 64. A detailed medical history and physical examination will be conducted to confirm your health status.

2 pre-study requirements

If you are a woman of childbearing potential or a male participant, you must practice effective contraception during the study and for at least 90 days after your last dose of the study treatment.

You must be willing and able to tolerate a nasal wash procedure, which will be conducted at the screening stage.

3 communication and adherence

You must have the ability to communicate well in the Dutch language and be willing to adhere to the prohibitions and restrictions specified in the study protocol.

4 study medication administration

During the study, you will receive either the study medication, 2-deoxy-D-glucose, or a placebo. The medication will be administered as a nasal spray solution.

The frequency and duration of administration will be determined by the study protocol, and you will be informed of these details during the study.

5 monitoring and assessments

Throughout the study, you will be monitored for any signs of rhinovirus-associated illness. This includes regular assessments to track any symptoms you may experience.

You will also be monitored for any adverse events or reactions to the study medication.

6 study completion

The study is expected to end by August 31, 2024. Upon completion, you may be required to attend a final assessment to evaluate your health status and any effects of the study medication.

Who Can Join the Study?

Healthy male or female participants aged 18 to 64 years. The investigator will decide if you are healthy based on your medical history and a physical exam.
Women of childbearing potential and all males must use effective birth control during the study and be willing to continue using it for at least 90 days after their last dose of the study treatment.
You must sign a consent form before any study-related procedures begin. This form shows that you understand the study and agree to participate.
You must be willing and able to undergo a nasal wash procedure at the start of the study. This is a process where a solution is used to clean your nasal passages.
You must be able to communicate well with the investigator in Dutch and be willing to follow the rules and restrictions of the study.

Who Cannot Join the Study?

Patients who are currently experiencing a rhinovirus-associated illness cannot participate. This means if you have a cold caused by the rhinovirus, you are not eligible.
Individuals under the age of 3 are not eligible to participate.
Participants must not be part of any vulnerable population groups. This generally refers to groups that may need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre for Human Drug Research	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	19.02.2024

Trial locations

Investigated drugs:

2-DEOXY-D-GLUCOSE

2-Deoxy-D-glucose is a medication being studied to see if it can help prevent illnesses caused by the rhinovirus, which is a common virus that can lead to colds. In this clinical trial, researchers are testing whether taking this medication before being exposed to the virus can stop people from getting sick. The goal is to find out if it can be an effective way to protect people from catching a cold caused by the rhinovirus. This study is important because it could lead to new ways to prevent colds, especially for people who are more vulnerable to getting sick.

Rhinovirus-associated illness – Rhinovirus-associated illness is a condition caused by infection with rhinoviruses, which are a common group of viruses responsible for the common cold. The illness typically begins with symptoms such as a runny nose, sore throat, sneezing, and congestion. As the illness progresses, individuals may experience coughing, headache, and mild body aches. Symptoms usually appear within two to three days after exposure to the virus and can last for up to two weeks. The condition is highly contagious and spreads easily through respiratory droplets from coughs and sneezes. While the symptoms can be uncomfortable, they are generally mild and self-limiting.

Trial ID:

2023-509311-91-01

Protocol code:

2-DG-02

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on 2-Deoxy-D-Glucose for Preventing Common Cold in Healthy Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?