Evaluating Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adults With Mild to Moderate COVID-19

NCT05069610 | Completed Phase 1 DMC

• 1 other identifier: AD17002-SC01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

AD17002 has demonstrated superior safety and efficacy as a nasal adjuvant function to an influenza vaccine in two completed clinical studies, and has innate immune modulatory and anti-inflammatory properties which could potentially be an effective treatment for SARS-CoV-2 infection. This Phase 2a, multi-center study is set up to assess the safety, tolerability, and potential efficacy of AD17002 in participants with mild to moderate COVID-19. The Immunogenicity of repeated doses of AD17002 will also be explored.

Conditions

COVID-19

Keywords

SARS-CoV-2; COVID-19; Therapy, viral clearance, immunomodulator, IFN, innate

Outcome Measures

Primary Outcomes (3)

• The proportion of participants who experience adverse events

  Clinicians and Patients reported AEs in the study period (7 weeks)

  7 weeks

• The proportion of participants with treatment-emergent adverse events (TEAE) leading to investigational medicinal products (IMPs) discontinuation

  Measuring and recording the AEs caused by treatment.

  7 weeks

• The nasal tolerability to investigational medicinal products (IMPs)

  Nasal symptoms will be assessed by participants and ear-nose-throat (ENT) specialists on symptoms include runny nose, stuffy nose, nasal discomfort, sneezing, lacrimation, change in vision, red eyes, facial swelling, nasal pain. Symptom Score Guide: 0= None; 1= Mild; 2= Moderately; 3= Severe

  7 weeks

Secondary Outcomes (8)

• The time to proportions of participants have a Ct≥30

  7 weeks

• Time to recovery* of fever (days)

  7 weeks

• Time to recovery* of sore throat (days)

  7 weeks

• Time to recovery* of cough (days

  7 weeks

• Time to recovery* of fatigue (days).

  7 weeks

Other Outcomes (3)

• Changes to anti-SARS CoV-2 antibody titers from baseline

  7 weeks

• Changes to pre-specified immunological markers

  7 weeks

• Viral genome integrity analysis

  Cohort 1, 3 weeks; Coohort 2, 8 days

Study Arms (4)

Standard of care + AD17002 (3 weekly doses)

EXPERIMENTAL

Received 3 weekly doses of AD17002 20 μg/dose of AD17002 by intranasal route

Biological: AD17002

Standard of care + Placebo (3 weekly doses)

PLACEBO COMPARATOR

Received 3 weekly doses of Placebo Formulation buffer by the intranasal route

Biological: Placebo (Formulation buffer)

Standard of care + AD17002 (3 doses in 5 days)

EXPERIMENTAL

Received 3 doses of AD17002 in 5 days 20 μg/dose of AD17002 by the intranasal route on days 1, 3, and 5

Biological: AD17002

Standard of care + Placebo (3 doses in 5 days)

PLACEBO COMPARATOR

Received 3 doses of Placebo in 5 days Formulation buffer by the ntranasal route on days 1, 3, and 5

Biological: Placebo (Formulation buffer)

Interventions

AD17002 BIOLOGICAL

A recombinant protein

Standard of care + AD17002 (3 doses in 5 days); Standard of care + AD17002 (3 weekly doses)

Placebo (Formulation buffer) BIOLOGICAL

Formulation buffer

Standard of care + Placebo (3 doses in 5 days); Standard of care + Placebo (3 weekly doses)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 20 and ≤ 70 years
• SARS-CoV-2 infection confirmed by real-time RT-PCR ≤ 4 days before randomization.
• Symptoms of mild to moderate illness with COVID-19 at Screening. At least one key COVID-19 symptom should have a score of 2 or higher using the scoring system in the diary card, with the exception of fever, sense of smell, and sense of taste where participants may be enrolled with a score of 1 or higher.
• Have a negative serum pregnancy test at Screening (for female participants of childbearing potential). A female participant who is of childbearing potential agrees to remain abstinent or use (or have their partner use) two acceptable methods of birth control within the projected duration of the study. Acceptable methods of birth control are: intrauterine device, hormonal contraception, diaphragm with spermicide, contraceptive sponge, condom, vasectomy, as per local regulations or guidelines.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5-fold of upper limit of normal (ULN) and total bilirubin ≤ 1.5-fold of ULN.
• Creatinine clearance ≥ 50 mL/min.
• A female participant who is not of childbearing potential is eligible without requiring the use of contraception. A female participant who is not of childbearing potential is defined as one who has either:
• Reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea), or
• At least six weeks postsurgical documented total hysterectomy and/or bilateral salpingo-oophorectomy, or
• Bilateral tubal ligation
• 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 moderate (pneumonia) or more severe illnesses with COVID-19 (as defined in the Taiwan CDC "Interim Guideline for Clinical Management of SARS-CoV-2 Infection Version 13" (Taiwan CDC, Clinical Management of SARS-CoV-2 Infection).
• 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.
• Participant who has a history of confirmed SARS-CoV-2 infection.
• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 \< 24 hours prior to the first IMP dosing.
• 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.
• Ongoing treatment with any specific immunotherapy at the time of the Screening Visit.
• Assessed by the Investigator to be ineligible to participate in the study.

Sponsors & Collaborators

• Advagene Biopharma Co. Ltd.: lead

Study Sites (2)

Advagene Biopharma

Taipei, 104, Taiwan

Location

Chang Gun Medical Foundation

Taoyuan District, 333423, Taiwan

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

• Mingi Chang, PhD

  Advagene Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 6, 2021
• Study Start: March 21, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 18, 2023
• Last Updated: December 22, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)