A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults (NCT06375772) | Clinical Trial Compass
TerminatedPhase 2
A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults
Stopped: Re-calculated sample size
Netherlands64 participantsStarted 2024-04-02
Plain-language summary
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male or female subjects 18 to 64 (inclusive at screening) years of age.
* Women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception until end of study.
* Signed informed consent form prior to any study-related procedures.
Exclusion Criteria:
* Active smoker or history of smoking \> 5 pack years.
* Upper or lower respiratory tract infection or febrile illness
* Presence (at screening) of serum RV-39 neutralizing antibody titer at greater than one in four (1:4) dilution.
* Nasopharyngeal swab indicative for Influenza or SARS-CoV2 infection by rapid antigen test at baseline.
* Prior inoculation with a virus from the same virus family as the challenge virus.
* Any anatomic or neurologic abnormality impairing the gag reflex, or associated with an increased risk of aspiration, or any abnormality significantly altering the anatomy of the nose or nasopharynx in a substantial way that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge.
* Positive Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
* Any confirmed or suspected disease or condition associated with immune system impairment, including auto-immune diseases, asplenia or recurrent severe infections.
* Active allergic rhinitis or hay fever.
* Medical history or a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo