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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05664919
• Other study ID #: PRO-SA58-0001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2022
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7000
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• SA58 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.

Locations

Country	Name	City	State
China	Inner Mongolia Fourth Hospital	Hohhot	The Inner Mongolia Autonomous Region

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Life Sciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)