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
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
1 other identifier
interventional
281
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2022
CompletedFirst Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedMarch 13, 2023
March 1, 2023
2 months
March 1, 2023
March 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.
Day 1 to Day 10
Secondary Outcomes (2)
Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Day 1 to Day 10
Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Day 1 to Day 10
Study Arms (4)
Treatment Group 1
EXPERIMENTALTreatment Group 2
EXPERIMENTALControl Group 3
PLACEBO COMPARATORControl Group 4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100015, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 13, 2023
Study Start
October 20, 2022
Primary Completion
December 6, 2022
Study Completion
December 6, 2022
Last Updated
March 13, 2023
Record last verified: 2023-03