COVID-19
Conditions
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.
Interventions
DRUGSA58 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.
DRUGPlacebo
Placebo was provided by Sinovac Life Sciences Co. , Ltd.
Sponsors
Beijing Ditan Hospital
Sinovac Life Sciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic COVID-19 cases | Up to 30 days(during case surveillance period) | Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval | 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 during case surveillance period |
| The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR | Up to 30 days (during case surveillance period) | The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR during the case surveillance period. |
| 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) | Up to 30 days (during case surveillance period) | 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. |
| The peak Ct value | Up to 30 days (during case surveillance period) | The peak Ct value during the period of case surveillance |
| The number of days of infection | Up to 30 days (during case surveillance period) | The number of days of infection during the period of case surveillance. |
| The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical) | Up to 30 days (during case surveillance period) | The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)during the case surveillance period. |
Countries
China
Outcome results
None listed