COVID-19Phase 3NCT05787418
HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2
A Phase 3 study testing HH-120 Nasal Spray in people with COVID-19, run by Huahui Health at 2 sites in China.
Trial summary
This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- HH-120 Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 918 participants
- Where
- 2 sitesChina
- Study dates
- 31 Mar 2023to 17 Apr 2024
- Phase
- Phase 3
- 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 12 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 to 85 years old.
- Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test [RAT]).
- Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients.
- Participants with a negative RAT result within 2 hours prior to randomization.
- Fertile participants must agree to use a highly effective method of contraception.
- Participants being able and willing to provide informed consent prior to any study-specific procedure.
Who cannot join
- Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators).
- Those comorbid with asthma.
- Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
- Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization.
- Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc.
- Known history of allergy or reaction to any component of the study drug formulation.
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- Those who has received other treatment with anti-COVID-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first).
- Participants with nasal disease that is inconvenient or intolerant of nasal spray administration.
- Other reasons considered by the investigator to be unsuitable for the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, 100000
Huashan Hospital of Fudan University
Shanghai, 200000
About this study
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2
This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.
Read the detailed description
During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.
- Conditions
- COVID-19
- Being tested
- HH-120 Nasal Spray, Placebo
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2, Coronavirus disease 2019
- 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 8 times per day for 7 consecutive days
PlaceboDrug
Placebo 8 times per day for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| HH-120 group | Experimental | HH-120 Nasal Spray Receives: Drug: HH-120 Nasal Spray |
| Control group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of symptomatic SARS-CoV-2 infection
Incidence of participants with quantitative Real-Time polymerase chain reaction (qRT-PCR) confirmed SARS-CoV-2 infection and COVID-19 related symptom
Measured: Up to 7 days
Secondary outcomes (10)
The incidence of SARS-CoV-2 infection
Measured: Up to 7 days
The changes in SARS-CoV-2 viral nucleic acid load
Measured: Up to 7 days
The change of viral load by qRT-PCR
Measured: Up to 7 days
Incidence and severity of adverse events
Measured: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection
Measured: Up to 3 days
The incidence of symptomatic SARS-CoV-2 infection
Measured: Up to 5 days
Time to onset of first COVID-19 related symptom
Measured: Up to 7 days
Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death
Measured: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection in different subgroups
Measured: Up to 7 days
The incidence and titer of antidrug antibody (ADA)
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start31 Mar 2023
- Primary completion27 Mar 2024
- Study completion17 Apr 2024
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 918 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787418
- Sponsor's protocol ID
- HH120-NS311
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05787418
- Acronym / sponsor ID
- HH120-NS311
- Conditions
- COVID-19
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2, Coronavirus disease 2019
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 918 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 28 Mar 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 will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.
Detailed description
During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH-120 group | Experimental | Drug: HH-120 Nasal SprayHH-120 Nasal Spray |
| Control group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 12 to 85 years old.
- Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test [RAT]).
- Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients.
- Participants with a negative RAT result within 2 hours prior to randomization.
- Fertile participants must agree to use a highly effective method of contraception.
Key exclusion criteria (9 listed)
- Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators).
- Those comorbid with asthma.
- Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
- Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization.
- Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc.
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 8 times per day for 7 consecutive days | Drug | HH-120 group |
| PlaceboPlacebo 8 times per day for 7 consecutive days | Drug | Control group |
Primary outcome
The incidence of symptomatic SARS-CoV-2 infection
Time frame: Up to 7 days
Incidence of participants with quantitative Real-Time polymerase chain reaction (qRT-PCR) confirmed SARS-CoV-2 infection and COVID-19 related symptom
10 secondary outcomes
The incidence of SARS-CoV-2 infection
Time frame: Up to 7 days
The changes in SARS-CoV-2 viral nucleic acid load
Time frame: Up to 7 days
The change of viral load by qRT-PCR
Time frame: Up to 7 days
Incidence and severity of adverse events
Time frame: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection
Time frame: Up to 3 days
The incidence of symptomatic SARS-CoV-2 infection
Time frame: Up to 5 days
Time to onset of first COVID-19 related symptom
Time frame: Up to 7 days
Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death
Time frame: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection in different subgroups
Time frame: Up to 7 days
The incidence and titer of antidrug antibody (ADA)
Time frame: Up to 21 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 14 Oct 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HH-120 Nasal Spray in people with COVID-19, run by Huahui Health at 2 sites 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 6 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 incidence of symptomatic SARS-CoV-2 infection (time frame: Up to 7 days). 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 14 Oct 2026.