Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People
NCT ID: NCT05667714
Last Updated: 2023-01-12
Study Results
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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UNKNOWN
NA
2900 participants
INTERVENTIONAL
2022-11-26
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental Group A（ non-continuous exposure to COVID-19）
1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
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.
Control Group A（ non-continuous exposure to COVID-19）
575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day .
Placebo
Placebo was provided by Sinovac Life Sciences Co. , Ltd.
Experimental Group B (continuous exposure to COVID-19)
400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
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.
Control Group B(continuous exposure to COVID-19)
200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
Placebo
Placebo was provided by Sinovac Life Sciences Co. , Ltd.
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.
Placebo
Placebo was provided by Sinovac Life Sciences Co. , Ltd.
Eligibility Criteria
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Inclusion Criteria
* Had recent contact with an infected person, and the time of PCR sampling from a positive infected person, or the time of first contact with a positive infected person should not exceed 72 hours;
* The subjects can understand and voluntarily sign the informed consent form;
Exclusion Criteria
* Women are breastfeeding, pregnant, or planning to become pregnant during the study period;
* Participated in clinical trials of SARS-CoV-2 neutralizing antibody injections within 180 days prior to screening or clinical trials of other drugs within 4 weeks prior to screening;
* Subjects unable to cooperate with nasal spray inhalation;
* Body temperature at baseline (Day 0)\>37.0℃;
* Had a severe neurological disorder (epilepsy, convulsions or convulsions) or psychosis, and have a family history of psychosis;
* The researchers determined that the subjects had a serious chronic medical condition that could interfere with the conduct or completion of the study;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
18 Years
ALL
Yes
Sponsors
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Beijing Ditan Hospital
OTHER
Sinovac Life Sciences Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ronghua Jin
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Locations
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Beijing Ditan Hospital, Capital Medical University
Beijing, , China
Countries
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Other Identifiers
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PRO-SA58-0002
Identifier Type: -
Identifier Source: org_study_id
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