A Phase 2 interventional study of 2-Deoxy-D-glucose and Placebo in Acute Nasopharyngitis, sponsored by G.ST Antivirals GmbH. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by G.ST Antivirals GmbH · Phase 2, Interventional, and Prevention
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.
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study using the rhinovirus challenge model in healthy study participants aged 18 to 64 years.
The primary objective is to confirm the efficacy of 2-DG compared to placebo for the prevention of rhinovirus-associated illness.
Secondary objectives are
to evaluate pharmacokinetics of 2-DG
128 subjects, who have been pre-screened and found to be seronegative to rhinovirus type 39, are randomized 1:1 to either 2-DG (pre-exposure prophylaxis) or placebo the day prior to inoculation. Subjects receive 2-DG or placebo starting from the day prior to inoculation until 5 days post inoculation.
Interim safety and efficacy reviews are performed by a Safety Monitoring Committee.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 64 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →G.ST Antivirals GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each subject receives a multiple dose of a 3.5% 2-Deoxyglucose as nasal spray solution. The maximum daily dose is 56 mg/day if applied 4 times/day, over 7 days.
Drug: 2-Deoxy-D-glucose
Each subject receives a multiple dose of placebo as nasal spray solution. The dose is corresponding to the amount of solution needed in the serum group.
Other: Placebo
Intranasal administration
Also known as: 2-Deoxyglucose, 2-DG
Intranasal administration
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo
Difference in the rate of symptomatic illness and laboratory-confirmed infection
Time frame: baseline until day 22
Number of infected subjects
Difference in the number of subjects with laboratory-confirmed infections. A laboratory-confirmed infection is identified either by isolating rhinovirus on at least one day after the virus challenge using qPCR or by a 4-fold increase in neutralizing antibody titer to RV-39 from acute (day -1) to convalescent sera (day 22) using the neutralizing assay.
Time frame: baseline, days 2-22 after start of dosing
Difference in percent of infected subjects
Difference in percentage of subjects with laboratory-confirmed infections. A laboratory-confirmed infection is identified either by isolating rhinovirus on at least one day after the virus challenge using qPCR or by a 4-fold increase in neutralizing antibody titer to RV-39 from acute (day -1) to convalescent sera (day 22) using the neutralizing assay.
Time frame: baseline, days 2-22 after start of dosing
Difference in percent of days virus positive
Difference in the percentage of days with a positive virus load. A positive virus load is determined by isolating rhinovirus on at least one day following the virus challenge, either using qPCR or a TCID50 assay.
Time frame: days 2-6
Difference in peak nasal virus load
Virus load is confirmed by isolating rhinovirus on at least one day after the virus challenge, using either qPCR or a TCID50 assay.
Time frame: days 2-6
Difference in AUC nasal virus load
Difference in AUC log 10 nasal virus load. Virus load is confirmed by isolating rhinovirus on at least one day after the virus challenge, using either qPCR or a TCID50 assay.
Time frame: days 2-6
Difference in Total Jackson Symptom Score
The difference of total Jackson Symptom Score (4 point-liters scales from 0 to 3) where a lower score means a better outcome.
Time frame: days 2-6 after start of dosing
Duration of illness
In study participants with RAI duration of illness is the time to the first day of the two consecutive days with a total symptom score ≤ 1 that occurs after the subject has met the symptom criteria for a RAI. A lower duration means a better outcome.
Time frame: days 2-15 after start of dosing
Difference in percent of days Jackson Symptom Score positive
Percentage of days with positive Jackson Symptom Score ( score \>2), where a lower percentage means a better outcome compared to placebo.
Time frame: days 2-6 after start of dosing
Difference in Peak Jackson Symptom Score
The highest daily total of all patient-reported symptoms on the Jackson Cold Scale (4 point-liters scales from 0 to 3 where a lower score means a better outcome compared to placebo).
Time frame: days 2-6 after start of dosing
Difference in peak total WURSS-21
The highest daily total of all patient-reported symptoms on the WURSS-21 questionnaire (8-point Likert scales from 0 to 7) where a lower score means a better outcome compared to placebo.
Time frame: days 2-6 after start of dosing
Difference in AUC total WURSS-21
Difference in AUC total WURSS-21 based a score recorded through the WURSS-21 questionnaire (8-point Likert scales from 0 to 7) where lower score means a better outcome compared to placebo.
Time frame: days 2-6 after start of dosing
Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs)
Number of AEs and ADRs assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: from screening (day -56) until end of study (day 22± 2) after start of dosing
Biodistribution of multiple doses of 2-DG in plasma samples
Analysis of 2-DG concentrations in plasma samples measured by LCMS (μg/ml).
Time frame: baseline, days 6 and 22± 2 after start of dosing
Biodistribution of multiple doses of 2-DG in nasal wash samples
Analysis of 2-DG concentrations in nasal wash samples measured by LCMS (μg/ml).
Time frame: baseline, days 2-6 and day 22± 2 after start of dosing
Plan to share: No
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This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deoxyglucose
G.ST Antivirals GmbH