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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: SA58 Nasal Spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug group<br>3500 participants will use SA58 Nasal Spray in drug group. | Drug: SA58 Nasal Spray<br>* 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.<br>|
| No Intervention: Blank control group<br>3500 participants won't be given medication in blank control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 infection rates | COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period. | Up to 30 days(during case surveillance period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 30 days(during case surveillance period) |