SARS CoV 2 InfectionNCT05358873
Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail
A study testing Human IgG1 anti-SARS-CoV-2 antibody cocktail in people with SARS CoV 2 Infection and SARS-CoV-2 Acute Respiratory Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- Human IgG1 anti-SARS-CoV-2 antibody cocktail
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 20 Apr 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read 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 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.
- Being tested
- Human IgG1 anti-SARS-CoV-2 antibody cocktail, Placebo
- Keywords
- SARS-CoV-2, SARS-CoV-2 inhibition, Nasal Spray, Anti-SARS-CoV-2, Antibody Cocktail
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human IgG1 anti-SARS-CoV-2 antibody cocktailDevice
Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail
PlaceboDevice
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Tolerability and safety of the study product as measured by treatment emergent adverse events (TEAEs)
Measured: 1 Day
Secondary outcomes (1)
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
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start20 Apr 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital, Ever Medical Technology Co., Ltd., The Government Pharmaceutical Organization, Ministry of Health, Thailand, HIBIOCY CO., Ltd.
- Responsible party
- Sponsor
- Investigators
- Thanarathi Imsuwansr, MD, Principal investigator, National Cancer Institute, ThailandDhammika Leshan Wannigama, MD PhD, Study director, Chulalongkorn UniversityThitinan Jongthitinon, MD, Study chair, National Cancer Institute, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358873
- Sponsor's protocol ID
- DMS-001/2565
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37730833
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05358873
- Acronym / sponsor ID
- DMS-001/2565
- Keywords
- SARS-CoV-2, SARS-CoV-2 inhibition, Nasal Spray, Anti-SARS-CoV-2, Antibody Cocktail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital, Ever Medical Technology Co., Ltd., The Government Pharmaceutical Organization, Ministry of Health, Thailand, HIBIOCY CO., Ltd.
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Human IgG1 anti-SARS-CoV-2 antibody cocktail | Experimental | Device: Human IgG1 anti-SARS-CoV-2 antibody cocktailSubjects 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. |
| Placebo | Placebo comparator | Device: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female, ≥ 18 and ≤ 50 years of age with BMI ≥ 18 and ≤ 30 kg/m2
- Healthy as defined by:
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human IgG1 anti-SARS-CoV-2 antibody cocktailHypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail | Device | Human IgG1 anti-SARS-CoV-2 antibody cocktail |
| PlaceboNormal saline | Device | Placebo |
Primary outcome
Adverse events
Time frame: 1 Day
Tolerability and safety of the study product as measured by treatment emergent adverse events (TEAEs)
1 secondary outcome
Percentage of inhibition against SAR-CoV-2 in the nasal fluid
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Derived from this study: PubMed 37730833Imsuwansri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanarathi Imsuwansr, MD principal investigator
National Cancer Institute, Thailand
Dhammika Leshan Wannigama, MD PhD study director
Chulalongkorn University
Thitinan Jongthitinon, MD study chair
National Cancer Institute, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human IgG1 anti-SARS-CoV-2 antibody cocktail in people with SARS CoV 2 Infection and SARS-CoV-2 Acute Respiratory Disease, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.