Back to resultsA Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2
Primary Purpose
SARS-CoV-2 Infection
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HH-120 nasal spray 1
HH-120 nasal spray 2
Placebo Comparator 1
Placebo Comparator 2
Sponsored by
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria: Participants aged 18 to 65 years. Participants who have close contact with a SARS-CoV-2 infected individual (index case) are required to be randomized within 72 hours upon close contact. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent. Exclusion Criteria: Have a history of severe allergy or hyper-sensitivity to inhaled allergen. Pregnant or breastfeeding women. Have participated, within the last 180 days prior to the screening, in a clinical study involving an investigational intervention of SARS-CoV-2 neutralizing antibody. Have other conditions not suitable for the study per investigator's discretion.
Sites / Locations
- Beijing Ditan Hospital,Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Treatment Group 1
Treatment Group 2
Control Group 3
Control Group 4
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.
Secondary Outcome Measures
Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05765279
Brief Title
A Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2
Official Title
An Investigator Initiated Clinical Study To Evaluate the Efficacy and Safety of HH-120 Nasal Spray as Post Exposure Prophylaxis (PEP) Regimen in Adult Close Contacts of Individuals Infected With SARS-CoV-2
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
December 6, 2022 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
An Investigator-initiated, Randomized, Single-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of SARS-Cov-2 Post Exposure Prophylaxis and Safety of HH-120 nasal spray
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
281 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Title
Control Group 3
Arm Type
Placebo Comparator
Arm Title
Control Group 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HH-120 nasal spray 1
Intervention Description
HH-120 nasal spray 5 times daily for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
HH-120 nasal spray 2
Intervention Description
HH-120 nasal spray 8 times daily for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator 1
Intervention Description
Placebo nasal spray 5 times daily for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator 2
Intervention Description
Placebo nasal spray 8 times daily for 3 consecutive days
Primary Outcome Measure Information:
Title
Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.
Time Frame
Day 1 to Day 10
Secondary Outcome Measure Information:
Title
Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Time Frame
Day 1 to Day 10
Title
Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Time Frame
Day 1 to Day 10
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:
Participants aged 18 to 65 years.
Participants who have close contact with a SARS-CoV-2 infected individual (index case) are required to be randomized within 72 hours upon close contact.
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
Exclusion Criteria:
Have a history of severe allergy or hyper-sensitivity to inhaled allergen.
Pregnant or breastfeeding women.
Have participated, within the last 180 days prior to the screening, in a clinical study involving an investigational intervention of SARS-CoV-2 neutralizing antibody.
Have other conditions not suitable for the study per investigator's discretion.
Facility Information:
Facility Name
Beijing Ditan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2
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