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

Advagene Biopharma

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Biological: Placebo; Biological: AD17002 + Formulation buffer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05541510

AD17002-ID-CO

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

Low dose treatment group

Experimental group

Description:

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

Treatment:

Biological: AD17002 + Formulation buffer

High dose treatment group

Experimental group

Description:

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

Treatment:

Biological: AD17002 + Formulation buffer