SARS CoV 2 Infection Clinical Trial
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
| Verified date | April 2022 |
| Source | Chulalongkorn University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | July 1, 2022 |
| Est. primary completion date | July 1, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | National Cancer Institute of Thailand | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Chulalongkorn University | Ever Medical Technology Co., Ltd., HIBIOCY CO., Ltd., Ministry of Health, Thailand, Ramathibodi Hospital, The Government Pharmaceutical Organization |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | 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 | |
| Primary | Adverse events | Tolerability and safety of the study product as measured by treatment emergent adverse events (TEAEs) | 1 Day | |
| Secondary | 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 |