NCT05667714

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,900 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo was provided by Sinovac Life Sciences Co. , Ltd.

Timeline

• Start date: 2022-11-26
• Primary completion: 2022-12-30
• Completion: 2023-03-30
• First posted: 2022-12-29
• Last updated: 2023-01-12

Locations

1 site across 1 country: China