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
1 other identifier
interventional
7,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2022
CompletedFirst Submitted
Initial submission to the registry
December 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJanuary 12, 2023
December 1, 2022
2 months
December 23, 2022
January 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Infection rates of asymptomatic and symptomatic COVID-19 patients
Up to 30 days(during case surveillance period)
Incidence of mild, normal, severe, and critical COVID-19 cases
Up to 30 days(during case surveillance period)
The peak Ct value
Up to 30 days(during case surveillance period)
Differences in the number of days of negative RT-PCR
Up to 30 days(during case surveillance period)
Study Arms (2)
Drug group
EXPERIMENTAL3500 participants will use SA58 Nasal Spray in drug group.
Blank control group
NO INTERVENTION3500 participants won't be given medication in blank control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inner Mongolia Fourth Hospital
Hohhot, The Inner Mongolia Autonomous Region, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuo Zhang
Inner Mongolia Fourth Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2022
First Posted
December 27, 2022
Study Start
October 30, 2022
Primary Completion
December 31, 2022
Study Completion
March 31, 2023
Last Updated
January 12, 2023
Record last verified: 2022-12