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Clinical Trial Summary

AD17002 has demonstrated superior safety and efficacy as a nasal adjuvant function to an influenza vaccine in two completed clinical studies, and has innate immune modulatory and anti-inflammatory properties which could potentially be an effective treatment for SARS-CoV-2 infection. This Phase 2a, multi-center study is set up to assess the safety, tolerability, and potential efficacy of AD17002 in participants with mild COVID-19. The Immunogenicity of repeated doses of AD17002 will also be explored.


Clinical Trial Description

Participants who meet eligibility criteria will be isolated and confined to the study site to receive treatment for COVID-19. Eligible participants will be assigned to 2 cohorts, Cohort 1 and Cohort 2, in a sequential manner to undergo either a 3-dose (Cohort 1) or 5-dose (Cohort 2) treatment regimen. Within each cohort, participants will be randomized in a 2:1 ratio to receive standard of care treatment and add-on therapy of AD17002 at 20 μg or placebo. Randomized participants will be assigned a participant number. The participants, site personnel and the Sponsor will be blinded to the treatment assignment. Randomization will not be stratified and participants who withdraw from the study after starting treatment will not be replaced, except for participants who undergo sentinel dosing in Cohort 2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05069610
Study type Interventional
Source Advagene Biopharma Co. Ltd.
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 15, 2021
Completion date April 15, 2022

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