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

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

SA58 Nasal Spray

Placebo

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Beijing Ditan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

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

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

Experimental Group B (continuous exposure to COVID-19)

Control Group B(continuous exposure to COVID-19)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Incidence of symptomatic COVID-19 cases

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

Secondary Outcome Measures

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.

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

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.

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.

The peak Ct value

The peak Ct value during the period of case surveillance

The number of days of infection

The number of days of infection during the period of case surveillance.

Full Information

NCT ID

NCT05667714

First Posted

December 13, 2022

Last Updated

January 11, 2023

Sponsor

Sinovac Life Sciences Co., Ltd.

Collaborators

Beijing Ditan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05667714

Brief Title

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

Official Title

A Randomized, Single-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray, Among Close Contact With COVID-19 People

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 26, 2022 (Actual)

Primary Completion Date

December 30, 2022 (Actual)

Study Completion Date

March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Life Sciences Co., Ltd.

Collaborators

Beijing Ditan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

2900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Experimental Group B (continuous exposure to COVID-19)

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group B(continuous exposure to COVID-19)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SA58 Nasal Spray

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of symptomatic COVID-19 cases

Description

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 Outcome Measure Information:

Title

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)

Description

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