Coronavirus Disease 2019(COVID-19)NCT05659602
A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients
A study testing HH-120 Nasal Spray in people with Coronavirus Disease 2019(COVID-19), run by Beijing Ditan Hospital at 1 site in China.
Trial summary
To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronavirus Disease 2019(COVID-19)
- What is being tested?
- HH-120 Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2022to 3 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old.
- Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19.
- Participants being able and willing to provide informed consent prior to any study-specific procedure.
Who cannot join
- Participants with moderate or severe COVID-19.
- Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period.
- Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.).
- Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment.
- Participants with comorbid Malignancy or with a history of malignancy.
- Participants with active or uncontrolled systemic autoimmune disease.
- Insufficient function of key organs.
- Other reasons considered by the investigator to be unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19
To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.
Read the detailed description
During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.
- Conditions
- Coronavirus Disease 2019(COVID-19)
- Being tested
- HH-120 Nasal Spray
- Keywords
- COVID-19, Treatment
- 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 SprayBiological
HH-120 Nasal Spray 8-10 times per day for 6 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| HH-120 group | Experimental | HH-120 Nasal Spray Receives: Biological: HH-120 Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
Median time from first dose to achieving SARS-COV-2 clearance.
Measured: Up to 12 days
Proportion of participants with SARS-CoV-2 clearance.
Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.
Measured: Up to 12 days
Secondary outcomes (3)
Clinical recovery of COVID-19.
Time to sustained COVID-19 symptoms recovery; Time to COVID-19 symptoms improvement; Proportion of participants with sustained COVID-19 symptoms recovery; Proportion of participants with COVID-19 symptoms improvement.
Measured: Up to 12 days
Viral load.
Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.
Measured: Up to 12 days
Adverse event.
Incidence and severity of adverse events.
Measured: Up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start9 Jul 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019(COVID-19)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 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
- NCT05659602
- Sponsor's protocol ID
- HH120-IIT-NS05
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2022
- 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 Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19
- ClinicalTrials.gov ID
- NCT05659602
- Acronym / sponsor ID
- HH120-IIT-NS05
- Conditions
- Coronavirus Disease 2019(COVID-19)
- Keywords
- COVID-19, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 9 Jul 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 21 Dec 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.
To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.
Detailed description
During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HH-120 group | Experimental | Biological: HH-120 Nasal SprayHH-120 Nasal Spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years old.
- Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19.
- Participants being able and willing to provide informed consent prior to any study-specific procedure.
Key exclusion criteria (8 listed)
- Participants with moderate or severe COVID-19.
- Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period.
- Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.).
- Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment.
- Participants with comorbid Malignancy or with a history of malignancy.
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 8-10 times per day for 6 consecutive days | Biological | HH-120 group |
Primary outcome
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
Time frame: Up to 12 days
Median time from first dose to achieving SARS-COV-2 clearance.
Proportion of participants with SARS-CoV-2 clearance.
Time frame: Up to 12 days
Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.
3 secondary outcomes
Clinical recovery of COVID-19.
Time frame: Up to 12 days
Viral load.
Time frame: Up to 12 days
Adverse event.
Time frame: Up to 12 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 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.
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 Coronavirus Disease 2019(COVID-19), 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 3 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 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 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?
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days). (time frame: Up to 12 days). The study lists 2 primary outcomes in all. 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.