COVID-19Phase 1/2NCT05069610

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

A Phase 1/2 study testing AD17002 in people with COVID-19, run by Advagene Biopharma Co. Ltd. at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: AD17002
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 2 sitesTaiwan
Study dates: 21 Mar 2022to 18 Dec 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

Advagene Biopharma
Taipei, 104
Chang Gun Medical Foundation
Taoyuan, 333423

Other trials in Taiwan

About this study

Official title: A Parallel Treatment, Phase 2a, Double-blind, Randomized, Placebo-controlled, 4-arm Study to Evaluate the Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adult Aged 20 to 70 Years With Mild to Moderate COVID-19

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.

Read the detailed description

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 cycle threshold (Ct) was used as a surrogate biomarker for viral clearance in the exploratory study.

The COVID-19 pandemic has led to significant mortality in global populations and suppression of the economy. The prompt development of the vaccine for SARS-CoV-2 represents an unprecedented achievement for mankind, nevertheless, the unstoppable transmission of the virus highlights human's insufficient and lack of preparedness in mucosal immunity, which acts as the port of entries to not just SARS-CoV-2, but many viruses.

The AD17002, also known as LTh(αK), is an immunomodulator, which induces expression of type I and III interferons (IFN-I/III) from mucosal epithelial cells. The IFN-I/III are critical components to innate immunity, the first line defender against infection, and modulator and initiator of adaptive immunity. The IFN-I is antagonized by many SARS-CoV-2 viral proteins and studies have shown the association between IFN-I deficiency and severe COVID-19. In this study, we intended to treat subjects with AD17002, which induced nasal epithelial cells to express IFN-I/III.

Participants who meet the eligibility criteria will be isolated and confined to the study site to receive treatment for COVID-19. Eligible participants will be assigned to 2 cohorts, Cohort 1 and Cohort 2, sequentially. Cohort 1 will receive 3 doses of AD17002 or placebo weekly, while Cohort 2 will receive 3 doses of LTh(αK) or placebo every other day (Days 1, 3, and 5). Within each cohort, participants will be randomized in a 2:1 ratio to receive standard-of-care treatment and add-on therapy of AD17002 at 20 μg or placebo. Randomized participants will be assigned a participant number. The participants, site personnel, and the Sponsor will be blinded to the treatment assignment. Randomization will not be stratified and participants who withdraw from the study after starting treatment will not be replaced, except for participants who undergo sentinel dosing in Cohort 2.

Conditions: COVID-19
Being tested: AD17002, Placebo (Formulation buffer)
Keywords: SARS-CoV-2, COVID-19, Therapy, viral clearance, immunomodulator, IFN, innate
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AD17002Biological
A recombinant protein
Placebo (Formulation buffer)Biological
Formulation buffer

Study groups in NCT05069610
Study group	Role	What they receive
Standard of care + AD17002 (3 weekly doses)	Experimental	Received 3 weekly doses of AD17002 20 μg/dose of AD17002 by intranasal route Receives: Biological: AD17002
Standard of care + Placebo (3 weekly doses)	Placebo comparator	Received 3 weekly doses of Placebo Formulation buffer by the intranasal route Receives: 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 Receives: 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 Receives: Biological: Placebo (Formulation buffer)

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of participants who experience adverse events
Clinicians and Patients reported AEs in the study period (7 weeks)
Measured: 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.
Measured: 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
Measured: 7 weeks

Secondary outcomes (8)

The time to proportions of participants have a Ct≥30
Measuring the RT-PCR on RdRp and E gene
Measured: 7 weeks
Time to recovery* of fever (days)
Fever is defined as temperatures of ≥ 36.6°C (axilla), or ≥ 37.2°C (oral), or ≥ 37.8°C (rectal or tympanic) over a 48-hour period. Recovery of fever is defined as occurring when body temperature is < 36.6°C (axilla), or < 37.2°C (oral), or < 37.8°C (rectal or tympanic) over a 48-hour period.
Measured: 7 weeks
Time to recovery* of sore throat (days)
Recovery of sore throat is defined as occurring when the symptom of sore throat has resolved to a score of 0 over a 48 hour period
Measured: 7 weeks
Time to recovery* of cough (days
Recovery of cough is defined as occurring when the symptom of cough has resolved to a score of 0 over a 48 hour period
Measured: 7 weeks
Time to recovery* of fatigue (days).
Recovery of fatigue is defined as occurring when the symptom of fatigue has resolved to a score of 0 over a 48 hour period
Measured: 7 weeks
Time to recovery* of muscle/body pain (days)
Recovery of muscle/body pain is defined as occurring when the symptom of muscle/body pain has resolved to a score of 0 over a 48 hour period
Measured: 7 weeks
Time to recovery* of other symptoms (days)
Recovery of symptom is defined as occurring when the symptom has resolved to a score of 0 over a 48 hour period
Measured: 7 weeks
The mean change from baseline to each specified time point on National Early Warning Score 2 (NEWS2)
Clinicians or study staffs report the NEWS 2 scores for each subject.
Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 202218 Dec 2023

First posted6 Oct 2021
Study start21 Mar 2022
Primary completion31 Oct 2023
Study completion18 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05069610
Sponsor's protocol ID: AD17002-SC01
Status last verified: Dec 2021
First submitted: 4 Oct 2021
Last updated: 22 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Parallel Treatment, Phase 2a, Double-blind, Randomized, Placebo-controlled, 4-arm Study to Evaluate the Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adult Aged 20 to 70 Years With Mild to Moderate COVID-19
ClinicalTrials.gov ID: NCT05069610
Acronym / sponsor ID: AD17002-SC01
Conditions: COVID-19
Keywords: SARS-CoV-2, COVID-19, Therapy, viral clearance, immunomodulator, IFN, innate
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Advagene Biopharma Co. Ltd.Industry (pharma, biotech, devices)
Study start: 21 Mar 2022 (actual)
Primary completion: 31 Oct 2023 (actual)
Study completion: 18 Dec 2023 (actual)
First posted: 6 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Standard of care + AD17002 (3 weekly doses)	Experimental	Biological: AD17002Received 3 weekly doses of AD17002 20 μg/dose of AD17002 by intranasal route
Standard of care + Placebo (3 weekly doses)	Placebo comparator	Biological: Placebo (Formulation buffer)Received 3 weekly doses of Placebo Formulation buffer by the intranasal route
Standard of care + AD17002 (3 doses in 5 days)	Experimental	Biological: AD17002Received 3 doses of AD17002 in 5 days 20 μg/dose of AD17002 by the intranasal route on days 1, 3, and 5
Standard of care + Placebo (3 doses in 5 days)	Placebo comparator	Biological: Placebo (Formulation buffer)Received 3 doses of Placebo in 5 days Formulation buffer by the ntranasal route on days 1, 3, and 5

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (13 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AD17002A recombinant protein	Biological	Standard of care + AD17002 (3 doses in 5 days), Standard of care + AD17002 (3 weekly doses)
Placebo (Formulation buffer)Formulation buffer	Biological	Standard of care + Placebo (3 doses in 5 days), Standard of care + Placebo (3 weekly doses)

Primary outcome

The proportion of participants who experience adverse events
Time frame: 7 weeks
Clinicians and Patients reported AEs in the study period (7 weeks)
The proportion of participants with treatment-emergent adverse events (TEAE) leading to investigational medicinal products (IMPs) discontinuation
Time frame: 7 weeks
Measuring and recording the AEs caused by treatment.
The nasal tolerability to investigational medicinal products (IMPs)
Time frame: 7 weeks
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

8 secondary outcomes

The time to proportions of participants have a Ct≥30
Time frame: 7 weeks
Time to recovery* of fever (days)
Time frame: 7 weeks
Time to recovery* of sore throat (days)
Time frame: 7 weeks
Time to recovery* of cough (days
Time frame: 7 weeks
Time to recovery* of fatigue (days).
Time frame: 7 weeks
Time to recovery* of muscle/body pain (days)
Time frame: 7 weeks
Time to recovery* of other symptoms (days)
Time frame: 7 weeks
The mean change from baseline to each specified time point on National Early Warning Score 2 (NEWS2)
Time frame: 7 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mingi Chang, PhD study director

Advagene Biopharma

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AD17002 in people with COVID-19, run by Advagene Biopharma Co. Ltd. at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of participants who experience adverse events (time frame: 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05069610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.