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

Not Applicable

Active, not recruiting

• Conditions: COVID-19
• Interventions: Drug: SA58 Nasal Spray

• Registration Number: NCT05664919
• Lead Sponsor: Sinovac Life Sciences Co., Ltd.

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.

Study Timeline

• Study Start: 2022-10-30
• Status Verified: 2022-12
• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2022-12-23
• Study First Posted: 2022-12-27
• Primary Completion: 2022-12-31
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug group	SA58 Nasal Spray	3500 participants will use SA58 Nasal Spray in drug group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Inner Mongolia Fourth Hospital; 🇨🇳 Hohhot, The Inner Mongolia Autonomous Region, China