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| Name | Class |
|---|---|
| Beijing Ditan Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group A( non-continuous exposure to COVID-19) | Experimental | 1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. |
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| Control Group A( non-continuous exposure to COVID-19) | Placebo Comparator | 575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day . |
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| Experimental Group B (continuous exposure to COVID-19) | Experimental | 400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. |
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| Control Group B(continuous exposure to COVID-19) | Placebo Comparator | 200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. |
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| 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 |
|---|---|---|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronghua Jin | Beijing Ditan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | 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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| Placebo | Drug | Placebo was provided by Sinovac Life Sciences Co. , Ltd. |
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| 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) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |