A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19
Overview
- Phase
- Not Applicable
- Intervention
- HH-120 Nasal Spray
- Conditions
- Coronavirus Disease 2019(COVID-19)
- Sponsor
- Beijing Ditan Hospital
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.
Detailed Description
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.
Investigators
Ronghua Jin
Chief Physician
Beijing Ditan Hospital
Eligibility Criteria
Inclusion Criteria
- •18 to 65 years old.
- •Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-
- •Participants being able and willing to provide informed consent prior to any study-specific procedure.
Exclusion Criteria
- •Participants with moderate or severe COVID-
- •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.
Arms & Interventions
HH-120 group
HH-120 Nasal Spray
Intervention: HH-120 Nasal Spray
Outcomes
Primary Outcomes
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
Time Frame: Up to 12 days
Median time from first dose to achieving SARS-COV-2 clearance.
Proportion of participants with SARS-CoV-2 clearance.
Time Frame: Up to 12 days
Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.
Secondary Outcomes
- Clinical recovery of COVID-19.(Up to 12 days)
- Viral load.(Up to 12 days)
- Adverse event.(Up to 12 days)