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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
AD17002 + Formulation buffer
Placebo
Sponsored by
Advagene Biopharma Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring immunomodulator, intranasal, epithelial, nasal mucosal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • RSA UGMRecruiting
  • RSPI Sulianti Saroso
  • RSDC Wisma Atlit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo Comparator

Low dose treatment group

High dose treatment group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Time to disease improvement
Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale
Time to achieving the Patient Acceptable Symptom State (PASS)
Defined as the value of symptoms the patient considered to be well-being thresholds of the symptoms and function. The study incorporates the most widely used anchoring question to identify PASS cut-off points, which is: "Taking into account all your daily activities, do you consider your current state satisfactory in relation to pain level and functional impairment?" The response options were "Yes" or "No.

Secondary Outcome Measures

Vital signs evaluation
Measuring the changes to cardiac functions
Physical examination
Measuring changes to physical appearances.
Clinical laboratory assessment
Assessing the changes to hematological parameters
Adverse events assessment
Adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1 (Mild) : asymptomatic or mild symptoms Grade 2 (Moderate): Local, Minimal, Moderate or noninvasive Grade 3 (Severe): Severe or medically significant but not immediately life-threatening Grade 4 (Life-threatening): Life-threatening consequences; urgent intervention indicated Grade 5 (Fatal): Death related to AE
Treatment-emergent adverse events assessment (TEAE)
Measuring the proportion of participants with TEAE leading to investigational medicinal products (IMPs) discontinuation. AE will be presented by the following categories: Any TEAE Treatment-related TEAE Grade 3-4, drug-related TEAE Drug-related TEAE leading to death
Nasal tolerability examination
Assessing the nasal symptoms by PI or delegated personnel or qualified ear, nose, and throat (ENT) specialist Symptoms include color of mucosa, turbinate swelling (middle concha and inferior concha), secretion, infection, post-nasal drip, crusting, sign of bleeding, and polyps.
Viral clearance
Time to clearance of SARS-CoV-2, defined as 2 consecutive negative oropharyngeal swabs by RT-PCR test and report as cycle threshold (CT)
Viral clearance rate by PCR
Changes of CT of RdRp (a.k.a. nsp12) N and E gene assayed by RT-PCR test
PASS evaluation
Proportion of subjects achieving PASS at each visit
Clinical Progression Scale analysis
Proportion of subjects achieving ≧1 decrease on WHO 11-point Clinical Progression Scale at each visit
Days of COVID-19 symptomatic hospitalization
Days participants in hospital due to infection.
Proportion of COVID-19 symptomatic hospitalization
Proportion of participants has been hospitalized due to infection.
Oxygen supplement treatment
Days of participants receive oxygen supplement.
Oxygen supplement treatment rate
Oxygen supplement receiving rates among infected participants
Symptom relieve days
Time to alleviation of each predefined COVID-19-related symptoms
Symptom severity report
Severity of each targeted COVID-19 symptoms An assessment of common COVID-19-related symptoms according to the FDA Guidance for Industry: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Symptom Score Guide: 0= None; 1= Mild; 2= Moderately; 3= Severe
Mortality rate report
Proportion of participants with death (all cause)

Full Information

First Posted
August 5, 2022
Last Updated
July 24, 2023
Sponsor
Advagene Biopharma Co. Ltd.
Collaborators
Gadjah Mada University
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1. Study Identification

Unique Protocol Identification Number
NCT05541510
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advagene Biopharma Co. Ltd.
Collaborators
Gadjah Mada University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
immunomodulator, intranasal, epithelial, nasal mucosal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (formulation buffer) on treatment days 1, 3 and 5.
Arm Title
Low dose treatment group
Arm Type
Experimental
Arm Description
Participants will receive 20 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5.
Arm Title
High dose treatment group
Arm Type
Experimental
Arm Description
Participants will receive 40 μg of AD17002 in formulation buffer on treatment days 1, 3 and 5.
Intervention Type
Biological
Intervention Name(s)
AD17002 + Formulation buffer
Other Intervention Name(s)
LTh(αK)
Intervention Description
Intranasal innate immune modulator
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Formulation buffer control
Intervention Description
Formulation buffer
Primary Outcome Measure Information:
Title
Time to disease improvement
Description
Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale
Time Frame
[Day 1 to Day 29]
Title
Time to achieving the Patient Acceptable Symptom State (PASS)
Description
Defined as the value of symptoms the patient considered to be well-being thresholds of the symptoms and function. The study incorporates the most widely used anchoring question to identify PASS cut-off points, which is: "Taking into account all your daily activities, do you consider your current state satisfactory in relation to pain level and functional impairment?" The response options were "Yes" or "No.
Time Frame
[Day 1 to Day 29]
Secondary Outcome Measure Information:
Title
Vital signs evaluation
Description
Measuring the changes to cardiac functions
Time Frame
[Day 1 to Day 29]
Title
Physical examination
Description
Measuring changes to physical appearances.
Time Frame
[Day 1 to Day 29]
Title
Clinical laboratory assessment
Description
Assessing the changes to hematological parameters
Time Frame
[Day 1 to Day 29]
Title
Adverse events assessment
Description
Adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1 (Mild) : asymptomatic or mild symptoms Grade 2 (Moderate): Local, Minimal, Moderate or noninvasive Grade 3 (Severe): Severe or medically significant but not immediately life-threatening Grade 4 (Life-threatening): Life-threatening consequences; urgent intervention indicated Grade 5 (Fatal): Death related to AE
Time Frame
[Day 1 to Day 29]
Title
Treatment-emergent adverse events assessment (TEAE)
Description
Measuring the proportion of participants with TEAE leading to investigational medicinal products (IMPs) discontinuation. AE will be presented by the following categories: Any TEAE Treatment-related TEAE Grade 3-4, drug-related TEAE Drug-related TEAE leading to death
Time Frame
[Day 1 to Day 29]
Title
Nasal tolerability examination
Description
Assessing the nasal symptoms by PI or delegated personnel or qualified ear, nose, and throat (ENT) specialist Symptoms include color of mucosa, turbinate swelling (middle concha and inferior concha), secretion, infection, post-nasal drip, crusting, sign of bleeding, and polyps.
Time Frame
[Day 1 to Day 29]
Title
Viral clearance
Description
Time to clearance of SARS-CoV-2, defined as 2 consecutive negative oropharyngeal swabs by RT-PCR test and report as cycle threshold (CT)
Time Frame
[Day 1 to Day 29]
Title
Viral clearance rate by PCR
Description
Changes of CT of RdRp (a.k.a. nsp12) N and E gene assayed by RT-PCR test
Time Frame
[Day 1 to Day 29]
Title
PASS evaluation
Description
Proportion of subjects achieving PASS at each visit
Time Frame
[Day 1 to Day 29]
Title
Clinical Progression Scale analysis
Description
Proportion of subjects achieving ≧1 decrease on WHO 11-point Clinical Progression Scale at each visit
Time Frame
[Day 1 to Day 29]
Title
Days of COVID-19 symptomatic hospitalization
Description
Days participants in hospital due to infection.
Time Frame
[Day 1 to Day 29]
Title
Proportion of COVID-19 symptomatic hospitalization
Description
Proportion of participants has been hospitalized due to infection.
Time Frame
[Day 1 to Day 29]
Title
Oxygen supplement treatment
Description
Days of participants receive oxygen supplement.
Time Frame
[Day 1 to Day 29]
Title
Oxygen supplement treatment rate
Description
Oxygen supplement receiving rates among infected participants
Time Frame
[Day 1 to Day 29]
Title
Symptom relieve days
Description
Time to alleviation of each predefined COVID-19-related symptoms
Time Frame
[Day 1 to Day 29]
Title
Symptom severity report
Description
Severity of each targeted COVID-19 symptoms An assessment of common COVID-19-related symptoms according to the FDA Guidance for Industry: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Symptom Score Guide: 0= None; 1= Mild; 2= Moderately; 3= Severe
Time Frame
[Day 1 to Day 29]
Title
Mortality rate report
Description
Proportion of participants with death (all cause)
Time Frame
[Day 1 to Day 29]
Other Pre-specified Outcome Measures:
Title
Anti-SARS-CoV-2 specific IgG assessment
Description
The titers of anti-SARS-CoV-2 specific IgG of each participants are measured with ELISA
Time Frame
[Day 1 and Day 29]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 18 and ≤65 years old. Laboratory confirmed SARS-CoV-2 infection, with first positive PCR test results within the past 48 hours of randomization. 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. 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 Have a negative pregnancy test at Screening (for female participants of childbearing potential). 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. Exclusion Criteria: Participant has clinical signs suggestive of severe illnesses with SPO2≤94. Sign of severe pneumonia as determined by treating physician on X-ray or SPO2 Participant has CT≥25 at screening 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. Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 prior to PCR screening. Participant with breakthrough SARS-CoV-2 infection within 2 weeks of SARS-CoV-2 vaccination. 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. Intranasal medication or nasal topical treatment at the time of screen and study. Assessed by the Investigator to be ineligible to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dwi Aris Agung Nugrahaningsih, MD. PhD
Phone
+62 274 511103
Email
farmakologi.fk@ugm.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarir At Thobari, MD. PhD.
Organizational Affiliation
Gadjah Mada University
Official's Role
Study Chair
Facility Information:
Facility Name
RSA UGM
City
Yogyakarta
State/Province
Daerah Istimewa Yogyakarta
ZIP/Postal Code
55281
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efriadi Ismail, MD
Phone
+62 274 4530404
Facility Name
RSPI Sulianti Saroso
City
Kota Jkt Utara
State/Province
DKI Jakarta
ZIP/Postal Code
14340
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adria Rusli, MD.
Phone
+62 (021) 6506559-
Ext
62
Email
admin@rspisuliantisaroso.co.id
Facility Name
RSDC Wisma Atlit
City
Kota Jkt Utara
State/Province
DKI Jakarta
ZIP/Postal Code
14360
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efriadi Ismail, MD
Phone
+966571061162

12. IPD Sharing Statement

Learn more about this trial

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

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