Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations

Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel：An Open-label, Blank-controlled Study

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.

Inclusion Criteria:

• Medical staff working in the designated COVID-19 hospitals and Fangcang shelter hospitals (alternate care sites) of COVID-19 cases in Hohhot;
• Subjects were 18 years of age and older and in good health;
• Subjects volunteered to use COVID-19 neutralizing antibody nasal spray.

Exclusion Criteria:

• Previous history of severe allergies or sensitivity to inhaled allergens;
• Women were pregnant or breastfeeding;
• Subjects were unable to cooperate with nasal spray inhalation;
• Other conditions for which medication was not appropriate.