COVID-19NCT05747677
A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19
A study testing HH-120 Nasal Spray in people with COVID-19 and SARS-CoV-2 Infection, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
This study is to evaluate the efficacy of post-exposure prevention and safety of HH-120 nasal spray in participants who are caregivers of hospitalized patients infected with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- HH-120 Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2022to 6 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 or above;
- Caregivers of hospitalized children who are infected with SARS-CoV-2;
- Negative qRT-PCR nucleic acid test result during the screening;
- Willing and able to give written informed consent.
Who cannot join
- Those who have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum during the study or within 3 months after the end of the study;
- Female subjects who are positive for human chorionic gonadotropin (β-Human Chorionic Gonadotropin, β-HCG) or are breastfeeding;
- Have used antiviral drugs with a therapeutic effect on COVID-19 within 3 months before screening, including various monoclonal antibodies (tixagevimab and cilgavimab, tocilizumab, ambavirumab and romisvir, Bamlanivimab, Etesevimab, Bebtelovimab, Casirivimab and imdevimab, Sotrovimab), convalescent plasma, hydroxychloroquine, Paxlovid (Nimatevir/ritonavir), Azvudine, Baricitinib, molnupiravir, remdesivir, interference drug, ribavirin, arbidol and lopinavir, etc.; (except those with the wash-out time longer than 5 half-lives);
- Those who have participated in clinical trials of SARS-CoV-2 neutralizing antibodies or participated in clinical trials of other drugs within 4 weeks before screening;
- Those who have a history of severe allergies or are sensitive to inhaled allergens; or are known to be sensitive to the ingredients of the study drug, other monoclonal antibody drugs, and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukin, etc.) Factors, etc.) have allergies or hypersensitivity reactions;
- Those who have received the COVID-19 vaccine within 2 weeks before the study drug administration or plan to receive the COVID-19 vaccine during the study;
- Those who cannot tolerate with nasal spray treatment;
- Any other circumstances that the researchers deemed not suitable for participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100015
About this study
Official title: A Single-Arm Clinical Study Evaluating the Efficacy of Post-Exposure Prophylaxis , Safety, and Tolerability of HH-120 Nasal Spray in Close Contacts of SARS-CoV-2
This study is to evaluate the efficacy of post-exposure prevention and safety of HH-120 nasal spray in participants who are caregivers of hospitalized patients infected with SARS-CoV-2. HH-120 nasal spray are administrated 8-10 times to the participants per day until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- HH-120 Nasal Spray
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-120 Nasal SprayDrug
HH-120 nasal spray, 1 spray to each nostril of the participant each time,8-10 times per day, until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| HH-120 Nasal Spray | Experimental | Not described Receives: Drug: HH-120 Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects infected with SARS-CoV-2
Measured: As of the discharge of the SARS-CoV-2 infected patients, an average 1 week
Secondary outcomes (1)
The incidence and severity of adverse events and the serious adverse events
Measured: As of the 7th day after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start14 Jun 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronghua Jin, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747677
- Sponsor's protocol ID
- HH120-IIT-NS01
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Clinical Study Evaluating the Efficacy of Post-Exposure Prophylaxis , Safety, and Tolerability of HH-120 Nasal Spray in Close Contacts of SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05747677
- Acronym / sponsor ID
- HH120-IIT-NS01
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 28 Feb 2023 (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.
This study is to evaluate the efficacy of post-exposure prevention and safety of HH-120 nasal spray in participants who are caregivers of hospitalized patients infected with SARS-CoV-2. HH-120 nasal spray are administrated 8-10 times to the participants per day until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HH-120 Nasal Spray | Experimental | Drug: HH-120 Nasal Spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 18 or above;
- Caregivers of hospitalized children who are infected with SARS-CoV-2;
- Negative qRT-PCR nucleic acid test result during the screening;
- Willing and able to give written informed consent.
Key exclusion criteria (8 listed)
- Those who have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum during the study or within 3 months after the end of the study;
- Female subjects who are positive for human chorionic gonadotropin (β-Human Chorionic Gonadotropin, β-HCG) or are breastfeeding;
- Have used antiviral drugs with a therapeutic effect on COVID-19 within 3 months before screening, including various monoclonal antibodies (tixagevimab and cilgavimab, tocilizumab, ambavirumab and romisvir, Bamlanivimab, Etesevimab, Bebtelovimab, Casirivimab and imdevimab, Sotrovimab), convalescent plasma, hydroxychloroquine, Paxlovid (Nimatevir/ritonavir), Azvudine, Baricitinib, molnupiravir, remdesivir, interference drug, ribavirin, arbidol and lopinavir, etc.; (except those with the wash-out time longer than 5 half-lives);
- Those who have participated in clinical trials of SARS-CoV-2 neutralizing antibodies or participated in clinical trials of other drugs within 4 weeks before screening;
- Those who have a history of severe allergies or are sensitive to inhaled allergens; or are known to be sensitive to the ingredients of the study drug, other monoclonal antibody drugs, and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukin, etc.) Factors, etc.) have allergies or hypersensitivity reactions;
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 |
|---|---|---|
| HH-120 Nasal SprayHH-120 nasal spray, 1 spray to each nostril of the participant each time,8-10 times per day, until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first. | Drug | HH-120 Nasal Spray |
Primary outcome
The proportion of subjects infected with SARS-CoV-2
Time frame: As of the discharge of the SARS-CoV-2 infected patients, an average 1 week
1 secondary outcome
The incidence and severity of adverse events and the serious adverse events
Time frame: As of the 7th day after the last study drug administration
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 28 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HH-120 Nasal Spray in people with COVID-19 and SARS-CoV-2 Infection, run by Beijing Ditan Hospital at 1 site in China.
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 4 inclusion and 8 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 28 Feb 2023. 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 China. 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. 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?
The proportion of subjects infected with SARS-CoV-2 (time frame: As of the discharge of the SARS-CoV-2 infected patients, an average 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023.