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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Intranasal innate immune modulator
Formulation buffer
RSPI Sulianti Saroso
Kota Jkt Utara, DKI Jakarta, Indonesia
RSDC Wisma Atlit
Kota Jkt Utara, DKI Jakarta, Indonesia
RSA UGM
Yogyakarta, Special Region of Yogyakarta, Indonesia
Time to disease improvement
Defined as time to achieving ≥1 decrease on WHO 11-point Clinical Progression Scale
Time frame: [Day 1 to Day 29]
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.
Time frame: [Day 1 to Day 29]
Vital signs evaluation
Measuring the changes to cardiac functions
Time frame: [Day 1 to Day 29]
Physical examination
Measuring changes to physical appearances.
Time frame: [Day 1 to Day 29]
Clinical laboratory assessment
Assessing the changes to hematological parameters
Time frame: [Day 1 to Day 29]
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
Time frame: [Day 1 to Day 29]
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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
Time frame: [Day 1 to Day 29]
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.
Time frame: [Day 1 to Day 29]
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)
Time frame: [Day 1 to Day 29]
Viral clearance rate by PCR
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]
PASS evaluation
Proportion of subjects achieving PASS at each visit
Time frame: [Day 1 to Day 29]
Clinical Progression Scale analysis
Proportion of subjects achieving ≧1 decrease on WHO 11-point Clinical Progression Scale at each visit
Time frame: [Day 1 to Day 29]
Days of COVID-19 symptomatic hospitalization
Days participants in hospital due to infection.
Time frame: [Day 1 to Day 29]
Proportion of COVID-19 symptomatic hospitalization
Proportion of participants has been hospitalized due to infection.
Time frame: [Day 1 to Day 29]
Oxygen supplement treatment
Days of participants receive oxygen supplement.
Time frame: [Day 1 to Day 29]
Oxygen supplement treatment rate
Oxygen supplement receiving rates among infected participants
Time frame: [Day 1 to Day 29]
Symptom relieve days
Time to alleviation of each predefined COVID-19-related symptoms
Time frame: [Day 1 to Day 29]
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
Time frame: [Day 1 to Day 29]
Mortality rate report
Proportion of participants with death (all cause)
Time frame: [Day 1 to Day 29]