COVID-19Phase 2/3NCT05541510
Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19
A Phase 2/3 study testing AD17002 + Formulation buffer in people with COVID-19, run by Advagene Biopharma Co. Ltd. at 3 sites in Indonesia.
Trial summary
AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpoints in studies of nasal adjuvants or intranasal immunomodulators. This study aims to evaluate the safety and effectiveness of AD17002 in treating patients with mild to moderate COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- AD17002 + Formulation buffer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesIndonesia
- Study dates
- 1 Dec 2022to 25 Aug 2024
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 and ≤65 years old.
- Laboratory confirmed SARS-CoV-2 infection, with first positive PCR test results within the past 48 hours of randomization.
- Participants with COVID-19 symptoms within 5 days prior to the day of randomization, based on the following criteria: At least TWO of the following symptoms: Stuffy/runny nose, sore throat, shortness of breath, cough, low energy/tiredness, muscle/body aches, headache, chill/shivering, Fever (≥ 38ºC), nausea, vomiting, diarrhea, and loss of taste or smell.
- Have a mild or moderate form of COVID-19 defined as:
- respiratory rate ≤30 breaths per minute, heart rate ≤125 beats per minute; with saturation of oxygen (SpO2) ≥93% on room air at sea level No clinical signs listed in Inclusion Criteria #3 indicative of Severe Severity
- Have a negative pregnancy test at Screening (for female participants of childbearing potential).
- Participant or the participant's legal representative understands the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- Provide written informed consent for the study and willing to adhere to dose regimen and visit schedules.
Who cannot join
- Participant has clinical signs suggestive of severe illnesses with SPO2≤94.
- Sign of severe pneumonia as determined by treating physician on X-ray or SPO2
- Participant has CT≥25 at screening
- Participation in any other clinical study of an investigational agent treatment for SARS-CoV-2 infection within 30 days prior to the first IMP dosing.
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 prior to PCR screening.
- Participant with breakthrough SARS-CoV-2 infection within 2 weeks of SARS-CoV-2 vaccination.
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- History of severe renal disease (treatment with dialysis or phosphate binders) or clinically apparent hepatic impairment (e.g., jaundice, cholestasis, hepatic synthetic impairment, active hepatitis).
- Impaired cardiac function or clinically significant cardiac diseases as judged by the Investigator.
- History of anaphylaxis reaction to any known or unknown cause.
- Immunosuppressed persons as result of illness (e.g., HIV infection) or treatment.
- Documented history of Bell's palsy.
- History of allergic reaction to kanamycin.
- Immunosuppressive treatment within 3 months prior to the Screening Visit.
- Intranasal medication or nasal topical treatment at the time of screen and study.
- Assessed by the Investigator to be ineligible to participate in the study.
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
RSPI Sulianti Saroso
Kota Jkt Utara, DKI Jakarta, 14340
RSDC Wisma Atlit
Kota Jkt Utara, DKI Jakarta, 14360
RSA UGM
Yogyakarta, Special Region of Yogyakarta, 55281
About this study
Official title: A Phase 2/3, Double-blind, Randomized, Placebo-controlled, 3-arm Study to Evaluate the Safety, and Efficacy of AD17002 (LTh[αK]) Intranasal Spray in Male and Female Participants Aged 18 to 65 Years With Mild to Moderate COVID 19
AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpoints in studies of nasal adjuvants or intranasal immunomodulators. This study aims to evaluate the safety and effectiveness of AD17002 in treating patients with mild to moderate COVID-19.
All participants will be randomly divided into 1:1:1 groups and will receive standard treatment. Additionally, participants will be given either a placebo, 20, or 40 μg of AD17002 via intranasal delivery, and clinical progress will be compared.
- Conditions
- COVID-19
- Being tested
- AD17002 + Formulation buffer, Placebo
- Keywords
- immunomodulator, intranasal, epithelial, nasal mucosal
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD17002 + Formulation bufferBiological
Also called LTh(αK)
Intranasal innate immune modulator
PlaceboBiological
Also called Formulation buffer control
Formulation buffer
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Participants will receive placebo (formulation buffer) on treatment days 1, 3 and 5. Receives: Biological: Placebo |
| Low dose treatment group | Experimental | Participants will receive 20 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5. Receives: Biological: AD17002 + Formulation buffer |
| High dose treatment group | Experimental | Participants will receive 40 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5. Receives: Biological: AD17002 + Formulation buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease improvement
Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale
Measured: [Day 1 to Day 29]
Time to achieving the Patient Acceptable Symptom State (PASS)
Defined as the value of symptoms the patient considered to be well-being thresholds of the symptoms and function. The study incorporates the most widely used anchoring question to identify PASS cut-off points, which is:
"Taking into account all your daily activities, do you consider your current state satisfactory in relation to pain level and functional impairment?" The response options were "Yes" or "No.
Measured: [Day 1 to Day 29]
Secondary outcomes (17)
Vital signs evaluation
Measuring the changes to cardiac functions
Measured: [Day 1 to Day 29]
Physical examination
Measuring changes to physical appearances.
Measured: [Day 1 to Day 29]
Clinical laboratory assessment
Assessing the changes to hematological parameters
Measured: [Day 1 to Day 29]
Adverse events assessment
Adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1 (Mild) : asymptomatic or mild symptoms Grade 2 (Moderate): Local, Minimal, Moderate or noninvasive Grade 3 (Severe): Severe or medically significant but not immediately life-threatening Grade 4 (Life-threatening): Life-threatening consequences; urgent intervention indicated Grade 5 (Fatal): Death related to AE
Measured: [Day 1 to Day 29]
Treatment-emergent adverse events assessment (TEAE)
Measuring the proportion of participants with TEAE leading to investigational medicinal products (IMPs) discontinuation.
AE will be presented by the following categories:
Any TEAE Treatment-related TEAE Grade 3-4, drug-related TEAE Drug-related TEAE leading to death
Measured: [Day 1 to Day 29]
Nasal tolerability examination
Assessing the nasal symptoms by PI or delegated personnel or qualified ear, nose, and throat (ENT) specialist Symptoms include color of mucosa, turbinate swelling (middle concha and inferior concha), secretion, infection, post-nasal drip, crusting, sign of bleeding, and polyps.
Measured: [Day 1 to Day 29]
Viral clearance
Time to clearance of SARS-CoV-2, defined as 2 consecutive negative oropharyngeal swabs by RT-PCR test and report as cycle threshold (CT)
Measured: [Day 1 to Day 29]
Viral clearance rate by PCR
Changes of CT of RdRp (a.k.a. nsp12) N and E gene assayed by RT-PCR test
Measured: [Day 1 to Day 29]
PASS evaluation
Proportion of subjects achieving PASS at each visit
Measured: [Day 1 to Day 29]
Clinical Progression Scale analysis
Proportion of subjects achieving ≧1 decrease on WHO 11-point Clinical Progression Scale at each visit
Measured: [Day 1 to Day 29]
Days of COVID-19 symptomatic hospitalization
Days participants in hospital due to infection.
Measured: [Day 1 to Day 29]
Proportion of COVID-19 symptomatic hospitalization
Proportion of participants has been hospitalized due to infection.
Measured: [Day 1 to Day 29]
Oxygen supplement treatment
Days of participants receive oxygen supplement.
Measured: [Day 1 to Day 29]
Oxygen supplement treatment rate
Oxygen supplement receiving rates among infected participants
Measured: [Day 1 to Day 29]
Symptom relieve days
Time to alleviation of each predefined COVID-19-related symptoms
Measured: [Day 1 to Day 29]
Symptom severity report
Severity of each targeted COVID-19 symptoms An assessment of common COVID-19-related symptoms according to the FDA Guidance for Industry: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Symptom Score Guide: 0= None; 1= Mild; 2= Moderately; 3= Severe
Measured: [Day 1 to Day 29]
Mortality rate report
Proportion of participants with death (all cause)
Measured: [Day 1 to Day 29]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Dec 2022
- Primary completion5 Aug 2024
- Study completion25 Aug 2024
Why it stopped: The end of COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants confirmed for SARS-CoV-2 infection by PCR with CT values ≤28 will be randomized (1:1:1) to receive either AD17002 0 (placebo), 20, or 40 μg via the intranasal route on Days 1, 3, and 5.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advagene Biopharma Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gadjah Mada University
- Responsible party
- Sponsor
- Investigators
- Jarir At Thobari, MD. PhD., Study chair, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541510
- Sponsor's protocol ID
- AD17002-ID-CO
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Double-blind, Randomized, Placebo-controlled, 3-arm Study to Evaluate the Safety, and Efficacy of AD17002 (LTh[αK]) Intranasal Spray in Male and Female Participants Aged 18 to 65 Years With Mild to Moderate COVID 19
- ClinicalTrials.gov ID
- NCT05541510
- Acronym / sponsor ID
- AD17002-ID-CO
- Conditions
- COVID-19
- Keywords
- immunomodulator, intranasal, epithelial, nasal mucosal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The end of COVID-19 pandemic
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Advagene Biopharma Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Gadjah Mada University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 15 Sep 2022 (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.
AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpoints in studies of nasal adjuvants or intranasal immunomodulators. This study aims to evaluate the safety and effectiveness of AD17002 in treating patients with mild to moderate COVID-19.
All participants will be randomly divided into 1:1:1 groups and will receive standard treatment. Additionally, participants will be given either a placebo, 20, or 40 μg of AD17002 via intranasal delivery, and clinical progress will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible participants confirmed for SARS-CoV-2 infection by PCR with CT values ≤28 will be randomized (1:1:1) to receive either AD17002 0 (placebo), 20, or 40 μg via the intranasal route on Days 1, 3, and 5.
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Biological: PlaceboParticipants will receive placebo (formulation buffer) on treatment days 1, 3 and 5. |
| Low dose treatment group | Experimental | Biological: AD17002 + Formulation bufferParticipants will receive 20 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5. |
| High dose treatment group | Experimental | Biological: AD17002 + Formulation bufferParticipants will receive 40 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 and ≤65 years old.
- Laboratory confirmed SARS-CoV-2 infection, with first positive PCR test results within the past 48 hours of randomization.
- Participants with COVID-19 symptoms within 5 days prior to the day of randomization, based on the following criteria: At least TWO of the following symptoms: Stuffy/runny nose, sore throat, shortness of breath, cough, low energy/tiredness, muscle/body aches, headache, chill/shivering, Fever (≥ 38ºC), nausea, vomiting, diarrhea, and loss of taste or smell.
- Have a mild or moderate form of COVID-19 defined as:
- respiratory rate ≤30 breaths per minute, heart rate ≤125 beats per minute; with saturation of oxygen (SpO2) ≥93% on room air at sea level No clinical signs listed in Inclusion Criteria #3 indicative of Severe Severity
Key exclusion criteria (15 listed)
- Participant has clinical signs suggestive of severe illnesses with SPO2≤94.
- Sign of severe pneumonia as determined by treating physician on X-ray or SPO2
- Participant has CT≥25 at screening
- Participation in any other clinical study of an investigational agent treatment for SARS-CoV-2 infection within 30 days prior to the first IMP dosing.
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 prior to PCR screening.
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 |
|---|---|---|
| AD17002 + Formulation bufferAlso: LTh(αK)Intranasal innate immune modulator | Biological | High dose treatment group, Low dose treatment group |
| PlaceboAlso: Formulation buffer controlFormulation buffer | Biological | Placebo Comparator |
Primary outcome
Time to disease improvement
Time frame: [Day 1 to Day 29]
Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale
Time to achieving the Patient Acceptable Symptom State (PASS)
Time frame: [Day 1 to Day 29]
Defined as the value of symptoms the patient considered to be well-being thresholds of the symptoms and function. The study incorporates the most widely used anchoring question to identify PASS cut-off points, which is: "Taking into account all your daily activities, do you consider your current state satisfactory in relation to pain level and functional impairment?" The response options were "Yes" or "No.
17 secondary outcomes
Vital signs evaluation
Time frame: [Day 1 to Day 29]
Physical examination
Time frame: [Day 1 to Day 29]
Clinical laboratory assessment
Time frame: [Day 1 to Day 29]
Adverse events assessment
Time frame: [Day 1 to Day 29]
Treatment-emergent adverse events assessment (TEAE)
Time frame: [Day 1 to Day 29]
Nasal tolerability examination
Time frame: [Day 1 to Day 29]
Viral clearance
Time frame: [Day 1 to Day 29]
Viral clearance rate by PCR
Time frame: [Day 1 to Day 29]
PASS evaluation
Time frame: [Day 1 to Day 29]
Clinical Progression Scale analysis
Time frame: [Day 1 to Day 29]
Days of COVID-19 symptomatic hospitalization
Time frame: [Day 1 to Day 29]
Proportion of COVID-19 symptomatic hospitalization
Time frame: [Day 1 to Day 29]
Oxygen supplement treatment
Time frame: [Day 1 to Day 29]
Oxygen supplement treatment rate
Time frame: [Day 1 to Day 29]
Symptom relieve days
Time frame: [Day 1 to Day 29]
Symptom severity report
Time frame: [Day 1 to Day 29]
Mortality rate report
Time frame: [Day 1 to Day 29]
Results and safety
The study was stopped early (reason given: The end of COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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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.
Jarir At Thobari, MD. PhD. study chair
Gadjah Mada University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AD17002 + Formulation buffer in people with COVID-19, run by Advagene Biopharma Co. Ltd. at 3 sites in Indonesia.
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 8 inclusion and 15 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: The end of COVID-19 pandemic). 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?
Time to disease improvement (time frame: [Day 1 to Day 29]). The study lists 2 primary outcomes in all. 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 10 Sep 2025.