To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
HH-120 Nasal Spray 8-10 times per day for 6 consecutive days
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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.
Time frame: 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.
Time frame: Up to 12 days
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.
Time frame: Up to 12 days
Viral load.
Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.
Time frame: Up to 12 days
Adverse event.
Incidence and severity of adverse events.
Time frame: Up to 12 days
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