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

This is an open, blank controlled clinical trial to evaluate the efficacy and safety ofSA58 nasal spray in the prevention COVID-19 infection among health care workers at highrisk of SARS-CoV-2 infection.

Detailed Description

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.

Unknown status
COVID-19

Drug: SA58 Nasal Spray

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Inner Mongolia Fourth Hospital
Hohhot, The Inner Mongolia Autonomous Region, China

Shuo Zhang, Principal Investigator
Inner Mongolia Fourth Hospital

Sinovac Life Sciences Co., Ltd.
NCT Number
MeSH Terms
COVID-19