search
Back to results

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

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SA58 Nasal Spray
Sponsored by
Sinovac Life Sciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Inner Mongolia Fourth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Drug group

Blank control group

Arm Description

3500 participants will use SA58 Nasal Spray in drug group.

3500 participants won't be given medication in blank control group.

Outcomes

Primary Outcome Measures

COVID-19 infection rates
COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period.

Secondary Outcome Measures

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.
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.
The peak Ct value
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
Differences in the number of days of negative RT-PCR during the period of COVID-19 infection during the study period.

Full Information

First Posted
December 23, 2022
Last Updated
January 11, 2023
Sponsor
Sinovac Life Sciences Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05664919
Brief Title
Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations
Official Title
Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel：An Open-label, Blank-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug group
Arm Type
Experimental
Arm Description
3500 participants will use SA58 Nasal Spray in drug group.
Arm Title
Blank control group
Arm Type
No Intervention
Arm Description
3500 participants won't be given medication in blank control group.
Intervention Type
Drug
Intervention Name(s)
SA58 Nasal Spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
COVID-19 infection rates
Description
COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period.
Time Frame
Up to 30 days(during case surveillance period)
Secondary Outcome Measure Information:
Title
Infection rates of asymptomatic and symptomatic COVID-19 patients
Description
Infection rates of asymptomatic and symptomatic COVID-19 patients (i.e., confirmed cases) confirmed by RT-PCR during the study period.
Time Frame
Up to 30 days(during case surveillance period)
Title
Incidence of mild, normal, severe, and critical COVID-19 cases
Description
Incidence of mild, normal, severe, and critical COVID-19 cases confirmed by RT-PCR during the study period.
Time Frame
Up to 30 days(during case surveillance period)
Title
The peak Ct value
Description
The peak of Ct during the period of COVID-19 infection during the study period.
Time Frame
Up to 30 days(during case surveillance period)
Title
Differences in the number of days of negative RT-PCR
Description
Differences in the number of days of negative RT-PCR during the period of COVID-19 infection during the study period.
Time Frame
Up to 30 days(during case surveillance period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuo Zhang
Organizational Affiliation
Inner Mongolia Fourth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inner Mongolia Fourth Hospital
City
Hohhot
State/Province
The Inner Mongolia Autonomous Region
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs