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

Sinovac Life Sciences Co., Ltd.2,900 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

2,900

Conditions

COVID-19

Interventions

SA58 Nasal SprayDRUG

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.

PlaceboDRUG

Placebo was provided by Sinovac Life Sciences Co. , Ltd.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Incidence of symptomatic COVID-19 cases

Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period

Time frame: Up to 30 days(during case surveillance period)

Secondary Outcomes

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)

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.

Time frame: 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

Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval during case surveillance period

Time frame: Up to 30 days (during case surveillance period)

The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR

The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR during the case surveillance period.

Time frame: Up to 30 days (during case surveillance period)

The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)

The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)during the case surveillance period.

Time frame: Up to 30 days (during case surveillance period)

The peak Ct value

The peak Ct value during the period of case surveillance

Data from ClinicalTrials.gov

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