COVID-19
Conditions
Keywords
immunomodulator, intranasal, epithelial, nasal mucosal
Brief summary
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.
Interventions
BIOLOGICALAD17002 + Formulation buffer
Intranasal innate immune modulator
BIOLOGICALPlacebo
Formulation buffer
Sponsors
Gadjah Mada University
Advagene Biopharma Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Eligible participants confirmed for SARS-CoV-2 infection by PCR with CT values ≤28 will be randomized (1:1:1) to receive either AD17002 0 (placebo), 20, or 40 μg via the intranasal route on Days 1, 3, and 5.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieving the Patient Acceptable Symptom State (PASS) | [Day 1 to Day 29] | 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 to disease improvement | [Day 1 to Day 29] | Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical examination | [Day 1 to Day 29] | Measuring changes to physical appearances. |
| Clinical laboratory assessment | [Day 1 to Day 29] | Assessing the changes to hematological parameters |
| Adverse events assessment | [Day 1 to Day 29] | 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) | [Day 1 to Day 29] | 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 | [Day 1 to Day 29] | 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 | [Day 1 to Day 29] | 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 | [Day 1 to Day 29] | Changes of CT of RdRp (a.k.a. nsp12) N and E gene assayed by RT-PCR test |
| PASS evaluation | [Day 1 to Day 29] | Proportion of subjects achieving PASS at each visit |
| Days of COVID-19 symptomatic hospitalization | [Day 1 to Day 29] | Days participants in hospital due to infection. |
| Proportion of COVID-19 symptomatic hospitalization | [Day 1 to Day 29] | Proportion of participants has been hospitalized due to infection. |
| Oxygen supplement treatment | [Day 1 to Day 29] | Days of participants receive oxygen supplement. |
| Oxygen supplement treatment rate | [Day 1 to Day 29] | Oxygen supplement receiving rates among infected participants |
| Symptom relieve days | [Day 1 to Day 29] | Time to alleviation of each predefined COVID-19-related symptoms |
| Symptom severity report | [Day 1 to Day 29] | 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 | [Day 1 to Day 29] | Proportion of participants with death (all cause) |
| Clinical Progression Scale analysis | [Day 1 to Day 29] | Proportion of subjects achieving ≧1 decrease on WHO 11-point Clinical Progression Scale at each visit |
| Vital signs evaluation | [Day 1 to Day 29] | Measuring the changes to cardiac functions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anti-SARS-CoV-2 specific IgG assessment | [Day 1 and Day 29] | The titers of anti-SARS-CoV-2 specific IgG of each participants are measured with ELISA |
Countries
Indonesia
Outcome results
None listed