Clinical trial NCT05358873: Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail
Official title: A Phase I Double-blind, Randomized, Placebo-controlled Study to Evaluate Safety of Hypromellose-based Nasal Spray Solution Containing Human IgG1 Anti-SARS-CoV-2 Antibody Cocktail in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS CoV 2 Infection
SARS-CoV-2 Acute Respiratory Disease
Keywords: SARS-CoV-2
SARS-CoV-2 inhibition
Nasal Spray
Anti-SARS-CoV-2
Antibody Cocktail
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Ramathibodi Hospital
name: Ever Medical Technology Co., Ltd.
name: The Government Pharmaceutical Organization
name: Ministry of Health, Thailand
name: HIBIOCY CO., Ltd.
First posted: 2022-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tolerability and safety of the study product will be evaluated when given 3 times a day for 7 days in 36 healthy volunteers.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion criteria

1. Male or female, ≥ 18 and ≤ 50 years of age with BMI ≥ 18 and ≤ 30 kg/m2
2. Healthy as defined by:

   1. No previous clinically significant disease and surgery within 4 weeks prior to dosing.
   2. No previous sinus and nasal septum surgery or radiotherapy
   3. No evidence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease which the Investigator believes may be detrimental to the study or its aims.
   4. No evidence of febrile or infectious disease within 1 week prior to dosing.
3. Have received at least 2 doses of COVID-19 vaccine.
4. Have no history of close contact with COVID-19 patients within 2 weeks before enrolment
5. Have negative result of COVID-19 test using RT-PCR method using sample collected from nasopharyngeal or nasal or oropharyngeal swab within 72 hours before sinusoscopy
6. Provide signed written informed consent prior to the initiation of any study-specific procedures.
7. Willing and able to comply with the requirements of the protocol and be available for the planned duration of the trial.

Exclusion criteria

1. Any clinically significant abnormality at physical examination at screening or enrolment
2. Vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 40 or over 90 mmHg, heart rate less than 40 or over 100 bpm, respiratory rate less than 10 or over 22 bpm, oral temperature less than 35.5°C or over 37.5°C) at screening.
3. Positive urine pregnancy test for women or women who are breast feeding
4. History of COVID-19 infection within 3 months before enrollment
5. History of allergic reactions or hypersensitivity to any excipients of the study products.
6. Use any nasal product use within 14 days prior to the first dosing
7. History of pulmonary infiltrate or pneumonia within 6 months before the screening visit.
8. Signs or symptoms of respiratory tract abnormalities such as allergies or chronic obstructive pulmonary disease.
9. History or signs of chronic allergic rhinitis that may interfere with study procedures and/or interpretation of local adverse events.

Primary outcomes:
measure: Adverse events
timeFrame: 1 Day
Secondary outcomes:
measure: Percentage of inhibition against SAR-CoV-2 in the nasal fluid
timeFrame: 14 Days
Other outcomes:
measure: Sino-Nasal Outcome Test-22 (SNOT-22)
timeFrame: 14 Days
measure: Total Nasal Symptom Score (TNSS) Questionnaire
timeFrame: 14 Days
Locations:
city: Bangkok
country: Thailand
facility: National Cancer Institute of Thailand
Study officials:
affiliation: National Cancer Institute, Thailand
name: Thanarathi Imsuwansr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Dhammika Leshan Wannigama, MD PhD
role: STUDY_DIRECTOR
affiliation: National Cancer Institute, Thailand
name: Thitinan Jongthitinon, MD
role: STUDY_CHAIR
References: