Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring immunomodulator, intranasal, epithelial, nasal mucosal
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.
Sites / Locations
- RSA UGMRecruiting
- RSPI Sulianti Saroso
- RSDC Wisma Atlit
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Low dose treatment group
High dose treatment group
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.