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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug group | Experimental | 3500 participants will use SA58 Nasal Spray in drug group. |
|
| Blank control group | No Intervention | 3500 participants won't be given medication in blank control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA58 Nasal Spray | Drug | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuo Zhang | Inner Mongolia Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia Fourth Hospital | Hohhot | The Inner Mongolia Autonomous Region | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |