Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People

Study Overview
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Brief Summary
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This is a randomized, single-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in close contact with COVID-19 people.

Detailed Description
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This study is a randomized, single-blind, placebo-controlled clinical trial in close contacts to COVID-19. The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to estimate the efficacy and safety of SA58 nasal spray in close contacts to COVID-19. A total of 2900 subjects were planned to be enrolled,including 2300 subjects who were non-continuous exposed to COVID-19 in group A,600 subjects who were continuous exposed to COVID-19 in group B. All subjects started medication on the day of enrollment. During the medication period, the subjects were given nasal spray once every 3 hours,about 5-6 times a day.

Official Title
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A Randomized, Single-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray, Among Close Contact With COVID-19 People

Conditions
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COVID-19

Intervention / Treatment
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* Drug: SA58 Nasal Spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 18 years and above on the day of enrollment; Had recent contact with an infected person, and the time of PCR sampling from a positive infected person, or the time of first contact with a positive infected person should not exceed 72 hours; The subjects can understand and voluntarily sign the informed consent form; Exclusion Criteria: Previous history of severe allergy or sensitivity to inhalation allergens; Women are breastfeeding, pregnant, or planning to become pregnant during the study period; Participated in clinical trials of SARS-CoV-2 neutralizing antibody injections within 180 days prior to screening or clinical trials of other drugs within 4 weeks prior to screening; Subjects unable to cooperate with nasal spray inhalation; Body temperature at baseline (Day 0)>37.0℃; Had a severe neurological disorder (epilepsy, convulsions or convulsions) or psychosis, and have a family history of psychosis; The researchers determined that the subjects had a serious chronic medical condition that could interfere with the conduct or completion of the study; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group A（ non-continuous exposure to COVID-19）<br>1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. | 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>|
| Placebo Comparator: Control Group A（ non-continuous exposure to COVID-19）<br>575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day . | Drug: Placebo<br>* Placebo was provided by Sinovac Life Sciences Co. , Ltd.<br>|
| Experimental: Experimental Group B (continuous exposure to COVID-19)<br>400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. | 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>|
| Placebo Comparator: Control Group B(continuous exposure to COVID-19)<br>200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. | Drug: Placebo<br>* Placebo was provided by Sinovac Life Sciences Co. , Ltd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic COVID-19 cases | Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period | Up to 30 days(during case surveillance period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by different Ct values at the time of diagnosis of primary cases(≤30, >30) | Incidence of symptomatic COVID-19 cases confirmed by RT-PCR when groups were stratified according to different Ct values at the time of diagnosis of primary cases(≤30, >30) during case surveillance period. | Up to 30 days (during case surveillance period) | 
| Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval | Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval during case surveillance period | Up to 30 days (during case surveillance period) | 
| The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR | The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR during the case surveillance period. | Up to 30 days (during case surveillance period) | 
| The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical) | The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)during the case surveillance period. | Up to 30 days (during case surveillance period) | 
| The peak Ct value | The peak Ct value during the period of case surveillance | Up to 30 days (during case surveillance period) | 
| The number of days of infection | The number of days of infection during the period of case surveillance. | Up to 30 days (during case surveillance period) |