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TerminatedNCT05541510Updated Sep 10, 2025

Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19

A Phase 2/3 interventional study of AD17002 + Formulation buffer and Placebo in COVID-19, sponsored by Advagene Biopharma Co. Ltd.. Terminated at 3 sites in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Advagene Biopharma Co. Ltd. · Phase 2/3, Interventional, and Treatment

Why this study was terminated
The end of COVID-19 pandemic
Phase
Phase 2/3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • COVID-19

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Keywords

  • immunomodulator
  • intranasal
  • epithelial
  • nasal mucosal
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 180 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Advagene Biopharma Co. Ltd. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged ≥ 18 and ≤65 years old.
  2. Laboratory confirmed SARS-CoV-2 infection, with first positive PCR test results within the past 48 hours of randomization.
  3. 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.

  4. 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

  5. Have a negative pregnancy test at Screening (for female participants of childbearing potential).
  6. 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.
  7. Provide written informed consent for the study and willing to adhere to dose regimen and visit schedules.

Exclusion criteria

Exclusion Criteria:

  1. Participant has clinical signs suggestive of severe illnesses with SPO2≤94.
  2. Sign of severe pneumonia as determined by treating physician on X-ray or SPO2
  3. Participant has CT≥25 at screening
  4. 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.
  5. Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 prior to PCR screening.
  6. Participant with breakthrough SARS-CoV-2 infection within 2 weeks of SARS-CoV-2 vaccination.
  7. 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).
  8. Impaired cardiac function or clinically significant cardiac diseases as judged by the Investigator.
  9. History of anaphylaxis reaction to any known or unknown cause.
  10. Immunosuppressed persons as result of illness (e.g., HIV infection) or treatment.
  11. Documented history of Bell's palsy.
  12. History of allergic reaction to kanamycin.
  13. Immunosuppressive treatment within 3 months prior to the Screening Visit.
  14. Intranasal medication or nasal topical treatment at the time of screen and study.
  15. Assessed by the Investigator to be ineligible to participate in the study.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Placebo comparator
    Placebo Comparator

    Participants will receive placebo (formulation buffer) on treatment days 1, 3 and 5.

    Biological: Placebo

  • Experimental
    Low dose treatment group

    Participants will receive 20 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5.

    Biological: AD17002 + Formulation buffer

  • Experimental
    High dose treatment group

    Participants will receive 40 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5.

    Biological: AD17002 + Formulation buffer

Interventions

  • BiologicalAD17002 + Formulation buffer

    Intranasal innate immune modulator

    Also known as: LTh(αK)

  • BiologicalPlacebo

    Formulation buffer

    Also known as: Formulation buffer control

06

What researchers measure

Primary outcomes

  1. Time to disease improvement

    Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale

    Time frame: [Day 1 to Day 29]

  2. 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.

    Time frame: [Day 1 to Day 29]

Secondary outcomes

  1. Vital signs evaluation

    Measuring the changes to cardiac functions

    Time frame: [Day 1 to Day 29]

  2. Physical examination

    Measuring changes to physical appearances.

    Time frame: [Day 1 to Day 29]

  3. Clinical laboratory assessment

    Assessing the changes to hematological parameters

    Time frame: [Day 1 to Day 29]

  4. 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

    Time frame: [Day 1 to Day 29]

  5. 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

    Time frame: [Day 1 to Day 29]

  6. 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.

    Time frame: [Day 1 to Day 29]

  7. 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)

    Time frame: [Day 1 to Day 29]

  8. Viral clearance rate by PCR

    Changes of CT of RdRp (a.k.a. nsp12) N and E gene assayed by RT-PCR test

    Time frame: [Day 1 to Day 29]

  9. PASS evaluation

    Proportion of subjects achieving PASS at each visit

    Time frame: [Day 1 to Day 29]

  10. Clinical Progression Scale analysis

    Proportion of subjects achieving ≧1 decrease on WHO 11-point Clinical Progression Scale at each visit

    Time frame: [Day 1 to Day 29]

  11. Days of COVID-19 symptomatic hospitalization

    Days participants in hospital due to infection.

    Time frame: [Day 1 to Day 29]

  12. Proportion of COVID-19 symptomatic hospitalization

    Proportion of participants has been hospitalized due to infection.

    Time frame: [Day 1 to Day 29]

  13. Oxygen supplement treatment

    Days of participants receive oxygen supplement.

    Time frame: [Day 1 to Day 29]

  14. Oxygen supplement treatment rate

    Oxygen supplement receiving rates among infected participants

    Time frame: [Day 1 to Day 29]

  15. Symptom relieve days

    Time to alleviation of each predefined COVID-19-related symptoms

    Time frame: [Day 1 to Day 29]

  16. 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

    Time frame: [Day 1 to Day 29]

  17. Mortality rate report

    Proportion of participants with death (all cause)

    Time frame: [Day 1 to Day 29]

Other outcomes

  1. Anti-SARS-CoV-2 specific IgG assessment

    The titers of anti-SARS-CoV-2 specific IgG of each participants are measured with ELISA

    Time frame: [Day 1 and Day 29]

07

Study locations

3 sites
  • RSPI Sulianti Saroso
    Kota Jkt Utara, DKI Jakarta 14340, Indonesia
  • RSDC Wisma Atlit
    Kota Jkt Utara, DKI Jakarta 14360, Indonesia
  • RSA UGM
    Yogyakarta, Special Region of Yogyakarta 55281, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05541510
Lead sponsor
Advagene Biopharma Co. Ltd.
Collaborators
Gadjah Mada University
Responsible party
Sponsor
First posted
Sep 15, 2022
Start date
Dec 1, 2022
Primary completion
Aug 5, 2024
Completion
Aug 25, 2024
Last update
Sep 10, 2025

Study contacts

Jarir At Thobari, MD. PhD.
study chair · Gadjah Mada University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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