Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Acute Respiratory Disease; SARS CoV 2 Infection
• Intervention / Treatment: Device: Human IgG1 anti-SARS-CoV-2 antibody cocktail; Device: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • National Cancer Institute of Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Human IgG1 anti-SARS-CoV-2 antibody cocktail; Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail
Placebo Comparator: 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.	Device: Placebo; Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Tolerability and safety of the study product as measured by treatment emergent adverse events (TEAEs)	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of inhibition against SAR-CoV-2 in the nasal fluid	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	14 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sino-Nasal Outcome Test-22 (SNOT-22)	Subject will be asked to respond to the SNOT-22 every day during enrolment to the end-of-study visit. The SNOT-22 is a validated 22-item CRS-specific QoL instrument which is scored where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be	14 Days
Total Nasal Symptom Score (TNSS) Questionnaire	Subject will be asked to respond to the TNSS questionnaire every day during enrolment to the end-of-study visit. Total nasal symptoms score (TNSS) is a brief questionnaire which evaluate the severity of main symptoms of allergic rhinitis. It consists of three questions which assess nasal obstruction, itching/sneezing and secretion/runny nose.	14 Days

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: Ramathibodi Hospital; Ministry of Health, Thailand; The Government Pharmaceutical Organization; Ever Medical Technology Co., Ltd.; HIBIOCY CO., Ltd.
• Investigators: Principal Investigator: Thanarathi Imsuwansr, MD, National Cancer Institute, Thailand; Study Director: Dhammika Leshan Wannigama, MD PhD, Chulalongkorn University; Study Chair: Thitinan Jongthitinon, MD, National Cancer Institute, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Nasal Spray; Anti-SARS-CoV-2; SARS-CoV-2 inhibition; Antibody Cocktail
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiration Disorders; Respiratory Tract Diseases; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: DMS-001/2565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No