Back to resultsA Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients
Primary Purpose
Coronavirus Disease 2019(COVID-19)
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HH-120 Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Disease 2019(COVID-19) focused on measuring COVID-19, Treatment
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Beijing Ditan Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HH-120 group
Arm Description
HH-120 Nasal Spray
Outcomes
Primary Outcome Measures
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.
Proportion of participants with SARS-CoV-2 clearance.
Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.
Secondary Outcome Measures
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.
Viral load.
Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.
Adverse event.
Incidence and severity of adverse events.
Full Information
NCT ID
NCT05659602
First Posted
December 20, 2022
Last Updated
September 25, 2023
Sponsor
Beijing Ditan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05659602
Brief Title
A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019(COVID-19)
Keywords
COVID-19, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HH-120 group
Arm Type
Experimental
Arm Description
HH-120 Nasal Spray
Intervention Type
Biological
Intervention Name(s)
HH-120 Nasal Spray
Intervention Description
HH-120 Nasal Spray 8-10 times per day for 6 consecutive days
Primary Outcome Measure Information:
Title
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
Description
Median time from first dose to achieving SARS-COV-2 clearance.
Time Frame
Up to 12 days
Title
Proportion of participants with SARS-CoV-2 clearance.
Description
Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.
Time Frame
Up to 12 days
Secondary Outcome Measure Information:
Title
Clinical recovery of COVID-19.
Description
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.
Time Frame
Up to 12 days
Title
Viral load.
Description
Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.
Time Frame
Up to 12 days
Title
Adverse event.
Description
Incidence and severity of adverse events.
Time Frame
Up to 12 days
Other Pre-specified Outcome Measures:
Title
Proportion of the participants who have progression of COVID-19.
Description
Proportion of participants who progress to moderate/severe/critical type of COVID-19 illness.
Time Frame
Up to 12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Beijing Ditan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients
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