Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations
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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.
Full 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.
Enrollment
Sex
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
7,000 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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