A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

Conditions
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COVID-19

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are ≥18 years of age . Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test. Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result. Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent. Exclusion Criteria: Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention. Bronchial asthma or chronic obstructive pulmonary disease （COPD). Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO). Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening. History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br> | Drug: HH-120 nasal spray<br>* Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.<br>|
| Experimental: Treatment Group 2<br> | Drug: HH-120 nasal spray<br>* Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days.<br>|
| Placebo Comparator: Control Group 3<br> | Drug: Placebo Comparator<br>* Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.<br>|
| Placebo Comparator: Control Group 4<br> | Drug: Placebo Comparator<br>* Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of viral load compared to the baseline |  | From baseline to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sustained clinical recovery of 11 COVID-19 symptoms. |  | From baseline till Day 28 | 
| Changes of viral load compared to the baseline. |  | From baseline till Day 28 | 
| Proportion of participants with moderate, severe, critical COVID-19 disease or death. |  | From baseline till Day 28 | 
| Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc. |  | From baseline till Day 28 |