Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail
- Conditions
- SARS-CoV-2 Acute Respiratory DiseaseSARS CoV 2 Infection
- Interventions
- Device: Human IgG1 anti-SARS-CoV-2 antibody cocktailDevice: Placebo
- Registration Number
- NCT05358873
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail is a medical device innovated to provide the dual-action physical barrier on nasal mucosa that aids the natural defence in which the mucus layer is fortified by a steric barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 VOCs, including Delta and Omicron, are locally trapped and blocked from entering the cells by the highly-specific human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail.
- Detailed Description
The transmission of SARS-CoV-2 through inhalation results in the nasal cavity and nasopharynx being the primary entry point of the virus and containing the highest viral load in the body during the virus incubation period. Recently, the administration of vaccines and agents via a nasal route has gained a lot of momentum because it takes advantage of the direct delivery of an agent to the site of primary infection. The local defence system, especially antibody-mediated immunity at the nasal epithelium, is crucial for COVID-19 prevention. However, people who responded to the vaccination against COVID-19 typically maintain sufficient local antibody levels in the nasal cavity for only a short period; hence a repeated boosting strategy is required to control the rate of SARS-CoV-2 breakthrough infection. In addition, the new VOCs such as Omicron are known to escape vaccine immunity; therefore, an innovative approach is needed in this unprecedented situation
Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail is a medical device innovated to provide the dual-action physical barrier on nasal mucosa that aids the natural defence in which the mucus layer is fortified by a steric barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 VOCs, including Delta and Omicron, are locally trapped and blocked from entering the cells by the highly-specific human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Human IgG1 anti-SARS-CoV-2 antibody cocktail Human IgG1 anti-SARS-CoV-2 antibody cocktail Subjects will receive the Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail (i.e., applied into both nostrils by spraying two times per nostril) 3 times a day from Day 1 to Day 7. Each day the study products will be self-administered at 8 am, 2 pm, and 8 pm. Placebo Placebo Subjects will receive the Normal saline solution (0.9% NaCl) nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail (i.e., applied into both nostrils by spraying two times per nostril) 3 times a day from Day 1 to Day 7. Each day the study products will be self-administered at 8 am, 2 pm, and 8 pm.
- Primary Outcome Measures
Name Time Method Adverse events 1 Day Tolerability and safety of the study product as measured by treatment emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method Percentage of inhibition against SAR-CoV-2 in the nasal fluid 14 Days SARS-CoV-2 inhibition property of the study product as measured by the percentage of inhibition against SAR-CoV-2 in the nasal fluid before and after the study product application via cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit
Trial Locations
- Locations (1)
National Cancer Institute of Thailand
🇹🇭Bangkok, Thailand