Clinical trial NCT05667714: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Ditan Hospital
First posted: 2022-12-29
Enrollment: 2900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of symptomatic COVID-19 cases
timeFrame: Up to 30 days(during case surveillance period)
Secondary outcomes:
measure: 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)
timeFrame: Up to 30 days (during case surveillance period)
measure: Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval
timeFrame: Up to 30 days (during case surveillance period)
measure: The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR
timeFrame: Up to 30 days (during case surveillance period)
measure: The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)
timeFrame: Up to 30 days (during case surveillance period)
measure: The peak Ct value
timeFrame: Up to 30 days (during case surveillance period)
measure: The number of days of infection
timeFrame: Up to 30 days (during case surveillance period)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Ditan Hospital
name: Ronghua Jin
role: PRINCIPAL_INVESTIGATOR
References: