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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: SA58 Nasal Spray

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 Type: Interventional
• Enrollment (Anticipated): 7000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • The Inner Mongolia Autonomous Region
    • Hohhot, The Inner Mongolia Autonomous Region, China
      • Inner Mongolia Fourth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug group; 3500 participants will use SA58 Nasal Spray in drug group.	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.
No Intervention: Blank control group; 3500 participants won't be given medication in blank control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Sinovac Life Sciences Co., Ltd.
• Investigators: Principal Investigator: Shuo Zhang, Inner Mongolia Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-SA58-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No