HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2

Study Overview
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Brief Summary
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This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.

Detailed Description
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During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.

Official Title
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A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2

Conditions
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COVID-19

Intervention / Treatment
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* Drug: HH-120 Nasal Spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 to 85 years old. Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test [RAT]). Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients. Participants with a negative RAT result within 2 hours prior to randomization. Fertile participants must agree to use a highly effective method of contraception. Participants being able and willing to provide informed consent prior to any study-specific procedure. Exclusion Criteria: Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators). Those comorbid with asthma. Those with a history of SARS-CoV-2 infection within 3 months prior to randomization. Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization. Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc. Known history of allergy or reaction to any component of the study drug formulation. Those who has received other treatment with anti-COVID-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first). Participants with nasal disease that is inconvenient or intolerant of nasal spray administration. Other reasons considered by the investigator to be unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HH-120 group<br>HH-120 Nasal Spray | Drug: HH-120 Nasal Spray<br>* HH-120 nasal spray 8 times per day for 7 consecutive days<br>|
| Placebo Comparator: Control group<br>Placebo | Drug: Placebo<br>* Placebo 8 times per day for 7 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of symptomatic SARS-CoV-2 infection | Incidence of participants with quantitative Real-Time polymerase chain reaction (qRT-PCR) confirmed SARS-CoV-2 infection and COVID-19 related symptom | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of SARS-CoV-2 infection |  | Up to 7 days | 
| The changes in SARS-CoV-2 viral nucleic acid load |  | Up to 7 days | 
| The change of viral load by qRT-PCR |  | Up to 7 days | 
| Incidence and severity of adverse events |  | Up to 21 days | 
| The incidence of symptomatic SARS-CoV-2 infection |  | Up to 3 days | 
| The incidence of symptomatic SARS-CoV-2 infection |  | Up to 5 days | 
| Time to onset of first COVID-19 related symptom |  | Up to 7 days | 
| Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death |  | Up to 21 days | 
| The incidence of symptomatic SARS-CoV-2 infection in different subgroups |  | Up to 7 days | 
| The incidence and titer of antidrug antibody (ADA) |  | Up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Acute Respiratory Syndrome Coronavirus 2, Coronavirus disease 2019