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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: HH-120 nasal spray 1
* Drug: HH-120 nasal spray 2
* Drug: Placebo Comparator 1
* Drug: Placebo Comparator 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br> | Drug: HH-120 nasal spray 1<br>* HH-120 nasal spray 5 times daily for 3 consecutive days<br>|
| Experimental: Treatment Group 2<br> | Drug: HH-120 nasal spray 2<br>* HH-120 nasal spray 8 times daily for 3 consecutive days<br>|
| Placebo Comparator: Control Group 3<br> | Drug: Placebo Comparator 1<br>* Placebo nasal spray 5 times daily for 3 consecutive days<br>|
| Placebo Comparator: Control Group 4<br> | Drug: Placebo Comparator 2<br>* Placebo nasal spray 8 times daily for 3 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection. |  | Day 1 to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |