Using AD17002 intranasal spray to treat 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

This study is testing if an intranasal spray called AD17002 can help adults with mild to moderate COVID-19 feel better and improve their immune response.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Advagene Biopharma Co. Ltd. (Industry-sponsored)
• Locations: 3 sites (Yogyakarta, Daerah Istimewa Yogyakarta and 2 other locations)
• Trial ID: NCT05541510 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of AD17002, an intranasal immunomodulator, in patients diagnosed with mild to moderate COVID-19. Participants will be randomly assigned to receive either a placebo or one of two doses of AD17002, alongside standard treatment. The study aims to enhance nasal mucosal immunity and monitor clinical progress over time. It includes adults aged 18 to 65 who have recently tested positive for SARS-CoV-2 and exhibit specific COVID-19 symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a recent positive COVID-19 test and mild to moderate symptoms.

Not a fit: Patients with severe COVID-19 symptoms or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing mild to moderate COVID-19 symptoms.

How similar studies have performed: Other studies have shown promising results with intranasal immunomodulators, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Yogyakarta, Daerah Istimewa Yogyakarta and 2 other locations

• Rsa Ugm — Yogyakarta, Daerah Istimewa Yogyakarta, Indonesia (Recruiting)
• RSPI Sulianti Saroso — Kota Jkt Utara, DKI Jakarta, Indonesia (Not_yet_recruiting)
• RSDC Wisma Atlit — Kota Jkt Utara, DKI Jakarta, Indonesia (Not_yet_recruiting)

Study contacts

• Study coordinator: Dwi Aris Agung Nugrahaningsih, MD. PhD

Conditions COVID-19; immunomodulator; intranasal; epithelial; nasal mucosal