This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,200
HH-120 nasal spray 8 times per day for 7 consecutive days
Placebo 8 times per day for 7 consecutive days
Beijing Ditan Hospital, Capital Medical University
Beijing, China
Huashan Hospital of Fudan University
Shanghai, China
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
Time frame: Up to 7 days
The incidence of SARS-CoV-2 infection
Time frame: Up to 7 days
The changes in SARS-CoV-2 viral nucleic acid load
Time frame: Up to 7 days
The change of viral load by qRT-PCR
Time frame: Up to 7 days
Incidence and severity of adverse events
Time frame: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection
Time frame: Up to 3 days
The incidence of symptomatic SARS-CoV-2 infection
Time frame: Up to 5 days
Time to onset of first COVID-19 related symptom
Time frame: Up to 7 days
Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death
Time frame: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection in different subgroups
Time frame: Up to 7 days
The incidence and titer of antidrug antibody (ADA)
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Time frame: Up to 21 days