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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: SA58 Nasal Spray; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 2900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Ditan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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 Comparator: 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 .	Drug: Placebo; Placebo was provided by Sinovac Life Sciences Co. , Ltd.
Experimental: 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.	Drug: 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 Comparator: 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.	Drug: Placebo; Placebo was provided by Sinovac Life Sciences Co. , Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of symptomatic COVID-19 cases	Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period	Up to 30 days(during case surveillance period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	Up to 30 days (during case surveillance period)
The peak Ct value	The peak Ct value during the period of case surveillance	Up to 30 days (during case surveillance period)
The number of days of infection	The number of days of infection during the period of case surveillance.	Up to 30 days (during case surveillance period)

Collaborators and Investigators

• Sponsor: Sinovac Life Sciences Co., Ltd.
• Collaborators: Beijing Ditan Hospital
• Investigators: Principal Investigator: Ronghua Jin, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-SA58-0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No