Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People

Sinovac

Status: Active, not recruiting

Conditions: COVID-19

Treatments: Drug: SA58 Nasal Spray; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05667714

PRO-SA58-0002

Details and patient eligibility

About

This is a randomized, single-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in close contact with COVID-19 people.

Full description

This study is a randomized, single-blind, placebo-controlled clinical trial in close contacts to COVID-19. The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to estimate the efficacy and safety of SA58 nasal spray in close contacts to COVID-19. A total of 2900 subjects were planned to be enrolled,including 2300 subjects who were non-continuous exposed to COVID-19 in group A,600 subjects who were continuous exposed to COVID-19 in group B. All subjects started medication on the day of enrollment. During the medication period, the subjects were given nasal spray once every 3 hours,about 5-6 times a day.

Enrollment: 2,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects aged 18 years and above on the day of enrollment;
• 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

• Previous history of severe allergy or sensitivity to inhalation allergens;
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,900 participants in 4 patient groups, including a placebo group

Experimental Group A（ non-continuous exposure to COVID-19）

Experimental group

Description:

1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.

Treatment:

Drug: SA58 Nasal Spray

Control Group A（ non-continuous exposure to COVID-19）

Placebo Comparator group

Description:

575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day .

Treatment:

Drug: Placebo

Experimental Group B (continuous exposure to COVID-19)

Experimental group

Description:

400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.

Treatment:

Drug: SA58 Nasal Spray

Control Group B(continuous exposure to COVID-19)

Placebo Comparator group

Description:

200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.

Treatment:

Drug: Placebo