A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients

Study Overview
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Brief Summary
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To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.

Detailed Description
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During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.

Official Title
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A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19

Conditions
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Coronavirus Disease 2019(COVID-19)

Intervention / Treatment
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* Biological: HH-120 Nasal Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 years old. Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19. Participants being able and willing to provide informed consent prior to any study-specific procedure. Exclusion Criteria: Participants with moderate or severe COVID-19. Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period. Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.). Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment. Participants with comorbid Malignancy or with a history of malignancy. Participants with active or uncontrolled systemic autoimmune disease. Insufficient function of key organs. Other reasons considered by the investigator to be unsuitable for the trial.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HH-120 group<br>HH-120 Nasal Spray | Biological: HH-120 Nasal Spray<br>* HH-120 Nasal Spray 8-10 times per day for 6 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days). | Median time from first dose to achieving SARS-COV-2 clearance. | Up to 12 days | 
| Proportion of participants with SARS-CoV-2 clearance. | Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12. | Up to 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recovery of COVID-19. | Time to sustained COVID-19 symptoms recovery; Time to COVID-19 symptoms improvement; Proportion of participants with sustained COVID-19 symptoms recovery; Proportion of participants with COVID-19 symptoms improvement. | Up to 12 days | 
| Viral load. | Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline. | Up to 12 days | 
| Adverse event. | Incidence and severity of adverse events. | Up to 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Treatment