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

NCT ID: NCT05664919

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-30

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Drug group

3500 participants will use SA58 Nasal Spray in drug group.

Group Type EXPERIMENTAL

SA58 Nasal Spray

Intervention Type DRUG

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.

Blank control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac Life Sciences Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuo Zhang

Role: PRINCIPAL_INVESTIGATOR

Inner Mongolia Fourth Hospital

Locations

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Inner Mongolia Fourth Hospital

Hohhot, The Inner Mongolia Autonomous Region, China

Site Status

Countries

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China

Other Identifiers

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PRO-SA58-0001

Identifier Type: -

Identifier Source: org_study_id

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