Clinical trial NCT05541510: Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: immunomodulator
intranasal
epithelial
nasal mucosal
Lead sponsor: Advagene Biopharma Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Gadjah Mada University
First posted: 2022-09-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants who are confirmed for SARS-CoV-2 infection by PCR with CT values ≤28 will be randomized (1:1:1) and received AD17002 0 (placebo), 20 or 40 μg via intranasal route on Day 1, 3 and 5.
Primary purpose: TREATMENT

Brief summary: AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpoints in nasal adjuvant or intranasal immunomodulator studies. The aim of this study is assessing the safety and efficacy of AD17002 in treating patients with mild to moderate COVID-19.

All participants will be 1:1:1 divided, randomly, and receive standard of treatment. In addition, participants will be given either placebo, 20 or 40 μg of AD17002 via intranasal route and clinical progresses will be compared.


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.

Primary outcomes:
measure: Time to disease improvement
timeFrame: [Day 1 to Day 29]
measure: Time to achieving the Patient Acceptable Symptom State (PASS)
timeFrame: [Day 1 to Day 29]
Secondary outcomes:
measure: Vital signs evaluation
timeFrame: [Day 1 to Day 29]
measure: Physical examination
timeFrame: [Day 1 to Day 29]
measure: Clinical laboratory assessment
timeFrame: [Day 1 to Day 29]
measure: Adverse events assessment
timeFrame: [Day 1 to Day 29]
measure: Treatment-emergent adverse events assessment (TEAE)
timeFrame: [Day 1 to Day 29]
measure: Nasal tolerability examination
timeFrame: [Day 1 to Day 29]
measure: Viral clearance
timeFrame: [Day 1 to Day 29]
measure: Viral clearance rate by PCR
timeFrame: [Day 1 to Day 29]
measure: PASS evaluation
timeFrame: [Day 1 to Day 29]
measure: Clinical Progression Scale analysis
timeFrame: [Day 1 to Day 29]
measure: Days of COVID-19 symptomatic hospitalization
timeFrame: [Day 1 to Day 29]
measure: Proportion of COVID-19 symptomatic hospitalization
timeFrame: [Day 1 to Day 29]
measure: Oxygen supplement treatment
timeFrame: [Day 1 to Day 29]
measure: Oxygen supplement treatment rate
timeFrame: [Day 1 to Day 29]
measure: Symptom relieve days
timeFrame: [Day 1 to Day 29]
measure: Symptom severity report
timeFrame: [Day 1 to Day 29]
measure: Mortality rate report
timeFrame: [Day 1 to Day 29]
Other outcomes:
measure: Anti-SARS-CoV-2 specific IgG assessment
timeFrame: [Day 1 and Day 29]
Locations:
city: Yogyakarta
country: Indonesia
facility: RSA UGM
state: Daerah Istimewa Yogyakarta
city: Kota Jkt Utara
country: Indonesia
facility: RSPI Sulianti Saroso
state: DKI Jakarta
city: Kota Jkt Utara
country: Indonesia
facility: RSDC Wisma Atlit
state: DKI Jakarta
Study officials:
affiliation: Gadjah Mada University
name: Jarir At Thobari, MD. PhD.
role: STUDY_CHAIR
References: