Evaluating Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adults With Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

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 to moderate COVID-19. The Immunogenicity of
      repeated doses of AD17002 will also be explored.
    

Detailed description: 
      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 to moderate COVID-19. The cycle threshold (Ct)
      was used as a surrogate biomarker for viral clearance in the exploratory study.

      The COVID-19 pandemic has led to significant mortality in global populations and suppression
      of the economy. The prompt development of the vaccine for SARS-CoV-2 represents an
      unprecedented achievement for mankind, nevertheless, the unstoppable transmission of the
      virus highlights human's insufficient and lack of preparedness in mucosal immunity, which
      acts as the port of entries to not just SARS-CoV-2, but many viruses.

      The AD17002, also known as LTh(αK), is an immunomodulator, which induces expression of type I
      and III interferons (IFN-I/III) from mucosal epithelial cells. The IFN-I/III are critical
      components to innate immunity, the first line defender against infection, and modulator and
      initiator of adaptive immunity. The IFN-I is antagonized by many SARS-CoV-2 viral proteins
      and studies have shown the association between IFN-I deficiency and severe COVID-19. In this
      study, we intended to treat subjects with AD17002, which induced nasal epithelial cells to
      express IFN-I/III.

      Participants who meet the 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, sequentially. Cohort 1 will receive 3 doses of AD17002 or placebo
      weekly, while Cohort 2 will receive 3 doses of LTh(αK) or placebo every other day (Days 1, 3,
      and 5). 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.
    

Intervention name(s): AD17002; Placebo (Formulation buffer)
Intervention type(s): Biological; Biological
Intervention description(s): A recombinant protein; Formulation buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV-2; COVID-19; Therapy, viral clearance, immunomodulator, IFN, innate