Acute NasopharyngitisPhase 2NCT06375772
A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults
A Phase 2 study testing 2-Deoxy-D-glucose in people with Acute Nasopharyngitis, run by G.ST Antivirals GmbH at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Nasopharyngitis
- What is being tested?
- 2-Deoxy-D-glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Apr 2024to 13 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 active asthma or chronic obstructive pulmonary disease (COPD) or any other pulmonary disease deemed by the investigator to increase the risk of participating in the study.
- Active nasal disease, e.g., nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
- Frequent epistaxis or nasal sinus surgery within 3 months before baseline.
- Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
- Evidence or history of drug or alcohol abuse.
- Positive test for drugs of abuse at screening or prior to study drug administration.
- Use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol) within 1 week or less than 5 half-lives (whichever is longer) prior to the first administration of investigational product.
- Use of any over the counter cold prophylaxis products including nasal sprays, C-vitamins, zinc or Echinacea within 2 weeks prior to the first administration of investigational product.
- Participation in an investigational medical product, vaccine or device study within 3 months or 5 half-lives prior to the study period (whichever is longer), or more than 4 times in the past year.
- Hypersensitivity/allergy to any of the investigational product ingredients.
- Individuals with close contact to at risk patient group (infants less than 3 years, the extremely elderly >80 years or infirm, pregnant women, patients with severe lung disease(e.g., asthma/cystic fibrosis (CF)/COPD), patients with primary or secondary immunodeficiencies or ongoing immunosuppressive therapy).
- Any clinically relevant abnormal history, physical finding, 12-lead safety ECG, vital signs, laboratory value at screening or any known factor that could interfere with the objectives of the trial or the safety of the volunteer. In the case of uncertain or questionable results, tests performed during screening may be repeated before inclusion to confirm eligibility or judged to be clinically irrelevant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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 the effect of 2-DG on the occurrence and course of rhinovirus infection
- to evaluate the effect of 2-DG on the severity of symptoms of rhinovirus infection
- to evaluate safety and tolerability of 2-DG administrated over 1 week in the presence of rhinovirus exposure
- 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.
- Conditions
- Acute Nasopharyngitis
- Being tested
- 2-Deoxy-D-glucose, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Deoxy-D-glucoseDrug
Also called 2-Deoxyglucose, 2-DG
Intranasal administration
PlaceboOther
Intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Active comparator | 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. Receives: Drug: 2-Deoxy-D-glucose |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline until day 22
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: baseline, days 2-6 and day 22± 2 after start of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start2 Apr 2024
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Why it stopped: Re-calculated sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute NasopharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- G.ST Antivirals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingrid de Visser-Kamerling, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375772
- Sponsor's protocol ID
- 2-DG-02
- Status last verified
- Nov 2024
- First submitted
- 8 Apr 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06375772
- Acronym / sponsor ID
- 2-DG-02
- Conditions
- Acute Nasopharyngitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Re-calculated sample size
- Enrolment
- 64 participants (actual)
- Lead sponsor
- G.ST Antivirals GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 the effect of 2-DG on the occurrence and course of rhinovirus infection
- to evaluate the effect of 2-DG on the severity of symptoms of rhinovirus infection
- to evaluate safety and tolerability of 2-DG administrated over 1 week in the presence of rhinovirus exposure
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Active comparator | Drug: 2-Deoxy-D-glucoseEach 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. |
| Placebo | Placebo comparator | Other: PlaceboEach 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-Deoxy-D-glucoseAlso: 2-Deoxyglucose, 2-DGIntranasal administration | Drug | Study Drug |
| PlaceboIntranasal administration | Other | Placebo |
Primary outcome
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo
Time frame: baseline until day 22
Difference in the rate of symptomatic illness and laboratory-confirmed infection
14 secondary outcomes
Number of infected subjects
Time frame: baseline, days 2-22 after start of dosing
Difference in percent of infected subjects
Time frame: baseline, days 2-22 after start of dosing
Difference in percent of days virus positive
Time frame: days 2-6
Difference in peak nasal virus load
Time frame: days 2-6
Difference in AUC nasal virus load
Time frame: days 2-6
Difference in Total Jackson Symptom Score
Time frame: days 2-6 after start of dosing
Duration of illness
Time frame: days 2-15 after start of dosing
Difference in percent of days Jackson Symptom Score positive
Time frame: days 2-6 after start of dosing
Difference in Peak Jackson Symptom Score
Time frame: days 2-6 after start of dosing
Difference in peak total WURSS-21
Time frame: days 2-6 after start of dosing
Difference in AUC total WURSS-21
Time frame: days 2-6 after start of dosing
Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs)
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
Time frame: baseline, days 6 and 22± 2 after start of dosing
Biodistribution of multiple doses of 2-DG in nasal wash samples
Time frame: baseline, days 2-6 and day 22± 2 after start of dosing
Results and safety
The study was stopped early (reason given: Re-calculated sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid de Visser-Kamerling, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2-Deoxy-D-glucose in people with Acute Nasopharyngitis, run by G.ST Antivirals GmbH at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Re-calculated sample size). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo (time frame: baseline until day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.