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

Not Applicable

Active, not recruiting

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: SA58 Nasal Spray

• Registration Number: NCT05667714
• Lead Sponsor: Sinovac Life Sciences Co., Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-11-26
• Status Verified: 2022-12
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2022-12-29
• Primary Completion: 2022-12-30
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2900

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group A（ non-continuous exposure to COVID-19）	Placebo	575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day .
Experimental Group B (continuous exposure to COVID-19)	SA58 Nasal Spray	400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
Control Group B(continuous exposure to COVID-19)	Placebo	200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
Experimental Group A（ non-continuous exposure to COVID-19）	SA58 Nasal Spray	1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic COVID-19 cases	Up to 30 days(during case surveillance period)	Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period

Secondary Outcome Measures

Name	Time	Method
The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR	Up to 30 days (during case surveillance period)	The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR during the case surveillance period.
The peak Ct value	Up to 30 days (during case surveillance period)	The peak Ct value during the period of case surveillance
The number of days of infection	Up to 30 days (during case surveillance period)	The number of days of infection during the period of case surveillance.
Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by different Ct values at the time of diagnosis of primary cases(≤30, >30)	Up to 30 days (during case surveillance period)	Incidence of symptomatic COVID-19 cases confirmed by RT-PCR when groups were stratified according to different Ct values at the time of diagnosis of primary cases(≤30, \>30) during case surveillance period.
Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval	Up to 30 days (during case surveillance period)	Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval during case surveillance period
The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)	Up to 30 days (during case surveillance period)	The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)during the case surveillance period.

Trial Locations

Locations (1)

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, China