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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05667714
• Other study ID #: PRO-SA58-0002
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 26, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: December 2022
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2900
• Est. completion date: March 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Sinovac Life Sciences Co., Ltd.	Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The peak Ct value	The peak Ct value during the period of case surveillance	Up to 30 days (during case surveillance period)
Secondary	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)