COVID-19Phase 2NCT05713318
A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
A Phase 2 study testing HH-120 nasal spray in people with COVID-19, run by Huahui Health at 16 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 200 participants
- Where
- 16 sitesChina
- Study dates
- 18 Jan 2023to 19 Jun 2023
- Phase
- Phase 2
- 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
- Participants who are ≥18 years of age .
- Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test.
- Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result.
- Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
Who cannot join
- Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention.
- Bronchial asthma or chronic obstructive pulmonary disease （COPD).
- Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
- Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening.
- History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Hospital of Jilin University
Changchun, Jilin, 130021
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, 350025
The People's Hospital of Gaozhou
Gaozhou, Guangdong, 525200
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, 510515
Lianyungang Oriental Hospital
Lianyungang, Jiangsu, 222042
Linfen Central Hospital
Linfen, Shanxi, 041000
Panjin Liaoyou Gem flower Hospital
Panjin, Liaoning, 124000
Qujing First People's Hospital
Qujing, Yunan, 100000
Wenzhou Traditional Chinese Medicine Hospital
Wenzhou, Zhejiang, 325000
Yixing People's Hospital
Wuxi, Jiangsu, 214200
Xiangtan Central Hospital
Xiangtan, Hunan, 411100
Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)
Yisa, Yunnan, 661199
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).
- Conditions
- COVID-19
- Being tested
- HH-120 nasal spray, Placebo Comparator
- 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
Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.
HH-120 nasal sprayDrug
Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days.
Placebo ComparatorDrug
Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.
Placebo ComparatorDrug
Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Not described Receives: Drug: HH-120 nasal spray |
| Treatment Group 2 | Experimental | Not described Receives: Drug: HH-120 nasal spray |
| Control Group 3 | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
| Control Group 4 | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of viral load compared to the baseline
Measured: From baseline to Day 7
Secondary outcomes (4)
Time to sustained clinical recovery of 11 COVID-19 symptoms.
Measured: From baseline till Day 28
Changes of viral load compared to the baseline.
Measured: From baseline till Day 28
Proportion of participants with moderate, severe, critical COVID-19 disease or death.
Measured: From baseline till Day 28
Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.
Measured: From baseline till Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start18 Jan 2023
- Primary completion19 Jun 2023
- Study completion19 Jun 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT05713318
- Sponsor's protocol ID
- HH120-NS215
- Status last verified
- Oct 2024
- First submitted
- 31 Jan 2023
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
- ClinicalTrials.gov ID
- NCT05713318
- Acronym / sponsor ID
- HH120-NS215
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 6 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 is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: HH-120 nasal spray |
| Treatment Group 2 | Experimental | Drug: HH-120 nasal spray |
| Control Group 3 | Placebo comparator | Drug: Placebo Comparator |
| Control Group 4 | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are ≥18 years of age .
- Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test.
- Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result.
- Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
Key exclusion criteria (5 listed)
- Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention.
- Bronchial asthma or chronic obstructive pulmonary disease （COPD).
- Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
- Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening.
- History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.
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 sprayNasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days. | Drug | Treatment Group 1 |
| HH-120 nasal sprayNasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days. | Drug | Treatment Group 2 |
| Placebo ComparatorNasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days. | Drug | Control Group 3 |
| Placebo ComparatorNasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days. | Drug | Control Group 4 |
Primary outcome
Changes of viral load compared to the baseline
Time frame: From baseline to Day 7
4 secondary outcomes
Time to sustained clinical recovery of 11 COVID-19 symptoms.
Time frame: From baseline till Day 28
Changes of viral load compared to the baseline.
Time frame: From baseline till Day 28
Proportion of participants with moderate, severe, critical COVID-19 disease or death.
Time frame: From baseline till Day 28
Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.
Time frame: From baseline till Day 28
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 10 Oct 2024.
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HH-120 nasal spray in people with COVID-19, run by Huahui Health at 16 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 4 inclusion and 5 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes of viral load compared to the baseline (time frame: From baseline to Day 7). 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 10 Oct 2024.