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

Primary Purpose

SARS CoV 2 Infection, SARS-CoV-2 Acute Respiratory Disease

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Human IgG1 anti-SARS-CoV-2 antibody cocktail

Placebo

About this trial

This is an interventional supportive care trial for SARS CoV 2 Infection focused on measuring SARS-CoV-2, SARS-CoV-2 inhibition, Nasal Spray, Anti-SARS-CoV-2, Antibody Cocktail

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

Male or female, ≥ 18 and ≤ 50 years of age with BMI ≥ 18 and ≤ 30 kg/m2
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.
Have received at least 2 doses of COVID-19 vaccine.
Have no history of close contact with COVID-19 patients within 2 weeks before enrolment
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
Provide signed written informed consent prior to the initiation of any study-specific procedures.
Willing and able to comply with the requirements of the protocol and be available for the planned duration of the trial.

Exclusion criteria

Any clinically significant abnormality at physical examination at screening or enrolment
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.
Positive urine pregnancy test for women or women who are breast feeding
History of COVID-19 infection within 3 months before enrollment
History of allergic reactions or hypersensitivity to any excipients of the study products.
Use any nasal product use within 14 days prior to the first dosing
History of pulmonary infiltrate or pneumonia within 6 months before the screening visit.
Signs or symptoms of respiratory tract abnormalities such as allergies or chronic obstructive pulmonary disease.
History or signs of chronic allergic rhinitis that may interfere with study procedures and/or interpretation of local adverse events.

Sites / Locations

National Cancer Institute of Thailand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Human IgG1 anti-SARS-CoV-2 antibody cocktail

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adverse events

Tolerability and safety of the study product as measured by treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05358873

First Posted

April 27, 2022

Last Updated

July 5, 2022

Sponsor

Chulalongkorn University

Collaborators

Ramathibodi Hospital, Ever Medical Technology Co., Ltd., The Government Pharmaceutical Organization, Ministry of Health, Thailand, HIBIOCY CO., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05358873

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

July 1, 2022 (Actual)

Study Completion Date

July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chulalongkorn University

Collaborators

Ramathibodi Hospital, Ever Medical Technology Co., Ltd., The Government Pharmaceutical Organization, Ministry of Health, Thailand, HIBIOCY CO., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Human IgG1 anti-SARS-CoV-2 antibody cocktail

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Human IgG1 anti-SARS-CoV-2 antibody cocktail

Intervention Description

Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

Normal saline

Primary Outcome Measure Information:

Title

Adverse events

Description

Tolerability and safety of the study product as measured by treatment emergent adverse events (TEAEs)

Time Frame

1 Day

Secondary Outcome Measure Information:

Title

Percentage of inhibition against SAR-CoV-2 in the nasal fluid

Description

Time Frame

14 Days

Other Pre-specified Outcome Measures:

Title

Sino-Nasal Outcome Test-22 (SNOT-22)

Description

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

Time Frame

14 Days

Title

Total Nasal Symptom Score (TNSS) Questionnaire

Description

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.

Time Frame

14 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Male or female, ≥ 18 and ≤ 50 years of age with BMI ≥ 18 and ≤ 30 kg/m2 Healthy as defined by: No previous clinically significant disease and surgery within 4 weeks prior to dosing. No previous sinus and nasal septum surgery or radiotherapy 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. No evidence of febrile or infectious disease within 1 week prior to dosing. Have received at least 2 doses of COVID-19 vaccine. Have no history of close contact with COVID-19 patients within 2 weeks before enrolment 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 Provide signed written informed consent prior to the initiation of any study-specific procedures. Willing and able to comply with the requirements of the protocol and be available for the planned duration of the trial. Exclusion criteria Any clinically significant abnormality at physical examination at screening or enrolment 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. Positive urine pregnancy test for women or women who are breast feeding History of COVID-19 infection within 3 months before enrollment History of allergic reactions or hypersensitivity to any excipients of the study products. Use any nasal product use within 14 days prior to the first dosing History of pulmonary infiltrate or pneumonia within 6 months before the screening visit. Signs or symptoms of respiratory tract abnormalities such as allergies or chronic obstructive pulmonary disease. History or signs of chronic allergic rhinitis that may interfere with study procedures and/or interpretation of local adverse events.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thanarathi Imsuwansr, MD

Organizational Affiliation

National Cancer Institute, Thailand

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dhammika Leshan Wannigama, MD PhD

Organizational Affiliation

Chulalongkorn University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Thitinan Jongthitinon, MD

Organizational Affiliation

National Cancer Institute, Thailand

Official's Role

Study Chair

Facility Information:

Facility Name

National Cancer Institute of Thailand

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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