NCT05765279CompletedNot Applicable
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
Beijing Ditan Hospital1 site in 1 country281 target enrollmentStarted: October 20, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 281
- Locations
- 1
- Primary Endpoint
- Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment Group 1
Experimental
Intervention: HH-120 nasal spray 1 (Drug)
Treatment Group 2
Experimental
Intervention: HH-120 nasal spray 2 (Drug)
Control Group 3
Placebo Comparator
Intervention: Placebo Comparator 1 (Drug)
Control Group 4
Placebo Comparator
Intervention: Placebo Comparator 2 (Drug)
Outcomes
Primary Outcomes
Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.
Time Frame: Day 1 to Day 10
Secondary Outcomes
- Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.(Day 1 to Day 10)
- Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.(Day 1 to Day 10)
Investigators
Ronghua Jin
Professor
Beijing Ditan Hospital
Study Sites (1)
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