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

NCT05358873 | Completed DMC

• 1 other identifier: DMS-001/2565
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

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

  1 Day

Secondary Outcomes (1)

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

  14 Days

Other Outcomes (2)

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

  14 Days

• Total Nasal Symptom Score (TNSS) Questionnaire

  14 Days

Study Arms (2)

Human IgG1 anti-SARS-CoV-2 antibody cocktail

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Human IgG1 anti-SARS-CoV-2 antibody cocktail DEVICE

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

Human IgG1 anti-SARS-CoV-2 antibody cocktail

Placebo DEVICE

Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead
• Ramathibodi Hospital: collaborator
• Ever Medical Technology Co., Ltd.: collaborator
• The Government Pharmaceutical Organization: collaborator
• Ministry of Health, Thailand: collaborator
• HIBIOCY CO., Ltd.: collaborator

Study Sites (1)

National Cancer Institute of Thailand

Bangkok, 10400, Thailand

Location

Related Publications (1)

• Imsuwansri T, Jongthitinon T, Pojdoung N, Meesiripan N, Sakarin S, Boonkrai C, Wongtangprasert T, Phakham T, Audomsun T, Attakitbancha C, Saelao P, Muanwien P, Tian MT, Tongchusak S, Sangruji B, Wannigama DL, Sawangmake C, Rodprasert W, Le QD, Purbantoro SD, Vasuntrarak K, Nantavisai S, Sirilak S, Uppapong B, Sapsutthipas S, Trisiriwanich S, Somporn T, Usoo A, Mingngamsup N, Phumiamorn S, Aumklad P, Arunprasert K, Patrojanasophon P, Opanasopit P, Pesirikan N, Nitisaporn L, Pitchayakorn J, Narkthong T, Mahong B, Chaiyo K, Srisutthisamphan K, Viriyakitkosol R, Aeumjaturapat S, Jongkaewwattana A, Bunnag S, Pisitkun T. Assessment of safety and intranasal neutralizing antibodies of HPMC-based human anti-SARS-CoV-2 IgG1 nasal spray in healthy volunteers. Sci Rep. 2023 Sep 20;13(1):15648. doi: 10.1038/s41598-023-42539-7.

  PMID: 37730833 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thanarathi Imsuwansr, MD

  National Cancer Institute, Thailand

  PRINCIPAL INVESTIGATOR

• Dhammika Leshan Wannigama, MD PhD

  Chulalongkorn University

  STUDY DIRECTOR

• Thitinan Jongthitinon, MD

  National Cancer Institute, Thailand

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Tolerability and safety of the study product will be evaluated when given 3 times a day for 7 days in 36 healthy volunteers.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: April 20, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)