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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: Placebo; Biological: AD17002 + Formulation buffer

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator; Participants will receive placebo (formulation buffer) on treatment days 1, 3 and 5.	Biological: Placebo; Formulation buffer; Other Names: Formulation buffer control
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; Intranasal innate immune modulator; Other Names: LTh(αK)
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; Intranasal innate immune modulator; Other Names: LTh(αK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital signs evaluation	Measuring the changes to cardiac functions	[Day 1 to Day 29]
Physical examination	Measuring changes to physical appearances.	[Day 1 to Day 29]
Clinical laboratory assessment	Assessing the changes to hematological parameters	[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	[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	[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.	[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)	[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	[Day 1 to Day 29]
PASS evaluation	Proportion of subjects achieving PASS at each visit	[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	[Day 1 to Day 29]
Days of COVID-19 symptomatic hospitalization	Days participants in hospital due to infection.	[Day 1 to Day 29]
Proportion of COVID-19 symptomatic hospitalization	Proportion of participants has been hospitalized due to infection.	[Day 1 to Day 29]
Oxygen supplement treatment	Days of participants receive oxygen supplement.	[Day 1 to Day 29]
Oxygen supplement treatment rate	Oxygen supplement receiving rates among infected participants	[Day 1 to Day 29]
Symptom relieve days	Time to alleviation of each predefined COVID-19-related symptoms	[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	[Day 1 to Day 29]
Mortality rate report	Proportion of participants with death (all cause)	[Day 1 to Day 29]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-SARS-CoV-2 specific IgG assessment	The titers of anti-SARS-CoV-2 specific IgG of each participants are measured with ELISA	[Day 1 and Day 29]

Collaborators and Investigators

• Sponsor: Advagene Biopharma Co. Ltd.
• Collaborators: Gadjah Mada University
• Investigators: Study Chair: Jarir At Thobari, MD. PhD., Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): August 25, 2024

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: intranasal; immunomodulator; epithelial; nasal mucosal
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; heat-labile enterotoxin, E coli
• Other Study ID Numbers: AD17002-ID-CO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No