This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.A total of 7000 medical personnel will be involved in this study: 3500 will use SA58 Nasal Spray in the drug group, and 3500 not use SA58 Nasal Spray in the blank control group. The medication is self-administered intranasally 1\~2 times per day with an interval of 6 hours for about 30 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
7,000
SA58 nasal spray , provided by Sinovac Life Sciences Co. , Ltd. mainly consists of neutralizing antibody of COVID-19, with 5 mg neutralizing antibody of COVID-19 per ml, 20 sprays per bottle.
Inner Mongolia Fourth Hospital
Hohhot, The Inner Mongolia Autonomous Region, China
COVID-19 infection rates
COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period.
Time frame: Up to 30 days(during case surveillance period)
Infection rates of asymptomatic and symptomatic COVID-19 patients
Infection rates of asymptomatic and symptomatic COVID-19 patients (i.e., confirmed cases) confirmed by RT-PCR during the study period.
Time frame: Up to 30 days(during case surveillance period)
Incidence of mild, normal, severe, and critical COVID-19 cases
Incidence of mild, normal, severe, and critical COVID-19 cases confirmed by RT-PCR during the study period.
Time frame: Up to 30 days(during case surveillance period)
The peak Ct value
The peak of Ct during the period of COVID-19 infection during the study period.
Time frame: Up to 30 days(during case surveillance period)
Differences in the number of days of negative RT-PCR
Differences in the number of days of negative RT-PCR during the period of COVID-19 infection during the study period.
Time frame: Up to 30 days(during case surveillance period)
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