COVID-19NCT05667714
Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People
A study testing SA58 Nasal Spray in people with COVID-19, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- SA58 Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,900 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- SA58 Nasal Spray, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA58 Nasal SprayDrug
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.
PlaceboDrug
Placebo was provided by Sinovac Life Sciences Co. , Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A（ non-continuous exposure to COVID-19） | Experimental | 1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. Receives: Drug: SA58 Nasal Spray |
| Control Group A（ non-continuous exposure to COVID-19） | Placebo comparator | 575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day . Receives: Drug: Placebo |
| Experimental Group B (continuous exposure to COVID-19) | Experimental | 400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. Receives: Drug: SA58 Nasal Spray |
| Control Group B(continuous exposure to COVID-19) | Placebo comparator | 200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic COVID-19 cases
Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period
Measured: Up to 30 days(during case surveillance period)
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 30 days (during case surveillance period)
The peak Ct value
The peak Ct value during the period of case surveillance
Measured: 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.
Measured: Up to 30 days (during case surveillance period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start26 Nov 2022
- Primary completion30 Dec 2022
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Ditan Hospital
- Responsible party
- Sponsor
- Investigators
- Ronghua Jin, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667714
- Sponsor's protocol ID
- PRO-SA58-0002
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05667714
- Acronym / sponsor ID
- PRO-SA58-0002
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Ditan Hospital
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A（ non-continuous exposure to COVID-19） | Experimental | Drug: SA58 Nasal Spray1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. |
| Control Group A（ non-continuous exposure to COVID-19） | Placebo comparator | Drug: Placebo575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day . |
| Experimental Group B (continuous exposure to COVID-19) | Experimental | Drug: SA58 Nasal Spray400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. |
| Control Group B(continuous exposure to COVID-19) | Placebo comparator | Drug: Placebo200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (8 listed)
- 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℃;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SA58 Nasal SpraySA58 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 | Experimental Group A（ non-continuous exposure to COVID-19）, Experimental Group B (continuous exposure to COVID-19) |
| PlaceboPlacebo was provided by Sinovac Life Sciences Co. , Ltd. | Drug | Control Group A（ non-continuous exposure to COVID-19）, Control Group B(continuous exposure to COVID-19) |
Primary outcome
Incidence of symptomatic COVID-19 cases
Time frame: Up to 30 days(during case surveillance period)
Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period
6 secondary outcomes
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)
Time frame: 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
Time frame: Up to 30 days (during case surveillance period)
The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR
Time frame: Up to 30 days (during case surveillance period)
The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)
Time frame: Up to 30 days (during case surveillance period)
The peak Ct value
Time frame: Up to 30 days (during case surveillance period)
The number of days of infection
Time frame: Up to 30 days (during case surveillance period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronghua Jin principal investigator
Beijing Ditan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SA58 Nasal Spray in people with COVID-19, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic COVID-19 cases (time frame: Up to 30 days(during case surveillance period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.