Status:
COMPLETED
Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
Ramathibodi Hospital
Ever Medical Technology Co., Ltd.
Conditions:
SARS CoV 2 Infection
SARS-CoV-2 Acute Respiratory Disease
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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 vi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05358873
Start Date
April 20 2022
End Date
July 1 2022
Last Update
July 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Institute of Thailand
Bangkok, Thailand, 10400