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

NCT05541510 | Terminated Phase 2 DMC

• 1 other identifier: AD17002-ID-CO
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

COVID-19

Keywords

immunomodulator; intranasal; epithelial; nasal mucosal

Outcome Measures

Primary Outcomes (2)

• Time to disease improvement

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

  [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.

  [Day 1 to Day 29]

Secondary Outcomes (17)

• Vital signs evaluation

  [Day 1 to Day 29]

• Physical examination

  [Day 1 to Day 29]

• Clinical laboratory assessment

  [Day 1 to Day 29]

• Adverse events assessment

  [Day 1 to Day 29]

• Treatment-emergent adverse events assessment (TEAE)

  [Day 1 to Day 29]

Other Outcomes (1)

• Anti-SARS-CoV-2 specific IgG assessment

  [Day 1 and Day 29]

Study Arms (3)

Placebo Comparator

PLACEBO COMPARATOR

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

Biological: Placebo

Low dose treatment group

EXPERIMENTAL

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

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.

Biological: AD17002 + Formulation buffer

Interventions

AD17002 + Formulation buffer BIOLOGICAL

Intranasal innate immune modulator

Also known as: LTh(αK)

High dose treatment group; Low dose treatment group

Placebo BIOLOGICAL

Formulation buffer

Also known as: Formulation buffer control

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Advagene Biopharma Co. Ltd.: lead
• Gadjah Mada University: collaborator

Study Sites (3)

RSPI Sulianti Saroso

Kota Jkt Utara, DKI Jakarta, 14340, Indonesia

Location

RSDC Wisma Atlit

Kota Jkt Utara, DKI Jakarta, 14360, Indonesia

Location

RSA UGM

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

heat-labile enterotoxin, E coli

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jarir At Thobari, MD. PhD.

  Gadjah Mada University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: September 15, 2022
• Study Start: December 1, 2022
• Primary Completion: August 5, 2024
• Study Completion: August 25, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

ID (3)