COVID-19
Conditions
Brief summary
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
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.
Interventions
DRUGSA58 Nasal Spray
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.
Sponsors
Sinovac Life Sciences Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 infection rates | Up to 30 days(during case surveillance period) | COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection rates of asymptomatic and symptomatic COVID-19 patients | Up to 30 days(during case surveillance period) | Infection rates of asymptomatic and symptomatic COVID-19 patients (i.e., confirmed cases) confirmed by RT-PCR during the study period. |
| Incidence of mild, normal, severe, and critical COVID-19 cases | Up to 30 days(during case surveillance period) | Incidence of mild, normal, severe, and critical COVID-19 cases confirmed by RT-PCR during the study period. |
| The peak Ct value | Up to 30 days(during case surveillance period) | The peak of Ct during the period of COVID-19 infection during the study period. |
| Differences in the number of days of negative RT-PCR | Up to 30 days(during case surveillance period) | Differences in the number of days of negative RT-PCR during the period of COVID-19 infection during the study period. |
Countries
China
Outcome results
None listed