AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpointsin nasal adjuvant or intranasal immunomodulator studies. The aim of this study isassessing the safety and efficacy of AD17002 in treating patients with mild to moderateCOVID-19.All participants will be 1:1:1 divided, randomly, and receive standard of treatment. Inaddition, participants will be given either placebo, 20 or 40 μg of AD17002 viaintranasal route and clinical progresses will be compared.
Not Provided
Biological: AD17002 + Formulation buffer
Intranasal innate immune modulator
Other Name: LTh(αK)
Biological: Placebo
Formulation buffer
Other Name: Formulation buffer control
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.
RSA UGM
Yogyakarta, Daerah Istimewa Yogyakarta, Indonesia
RSPI Sulianti Saroso
Kota Jkt Utara, DKI Jakarta, Indonesia
RSDC Wisma Atlit
Kota Jkt Utara, DKI Jakarta, Indonesia
Dwi Aris Agung Nugrahaningsih, MD. PhD
+62 274 511103
farmakologi.fk@ugm.ac.id
Jarir At Thobari, MD. PhD., Study Chair
Gadjah Mada University