COVID-19NCT05664919
Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations
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 an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection. 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?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2022to 31 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
- Medical staff working in the designated COVID-19 hospitals and Fangcang shelter hospitals (alternate care sites) of COVID-19 cases in Hohhot;
- Subjects were 18 years of age and older and in good health;
- Subjects volunteered to use COVID-19 neutralizing antibody nasal spray.
Who cannot join
- Previous history of severe allergies or sensitivity to inhaled allergens;
- Women were pregnant or breastfeeding;
- Subjects were unable to cooperate with nasal spray inhalation;
- Other conditions for which medication was not appropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Inner Mongolia Fourth Hospital
Hohhot, The Inner Mongolia Autonomous Region
About this study
Official title: Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel：An Open-label, Blank-controlled Study
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.
Read the detailed description
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.A total of 7000 medical personnel will be involved in this study: 3500 will use SA58 Nasal Spray in the drug group, and 3500 not use SA58 Nasal Spray in the blank control group. The medication is self-administered intranasally 1~2 times per day with an interval of 6 hours for about 30 days.
- Conditions
- COVID-19
- Being tested
- SA58 Nasal Spray
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Drug group | Experimental | 3500 participants will use SA58 Nasal Spray in drug group. Receives: Drug: SA58 Nasal Spray |
| Blank control group | No intervention | 3500 participants won't be given medication in blank control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 infection rates
COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period.
Measured: Up to 30 days(during case surveillance period)
Secondary outcomes (4)
Infection rates of asymptomatic and symptomatic COVID-19 patients
Infection rates of asymptomatic and symptomatic COVID-19 patients (i.e., confirmed cases) confirmed by RT-PCR during the study period.
Measured: Up to 30 days(during case surveillance period)
Incidence of mild, normal, severe, and critical COVID-19 cases
Incidence of mild, normal, severe, and critical COVID-19 cases confirmed by RT-PCR during the study period.
Measured: Up to 30 days(during case surveillance period)
The peak Ct value
The peak of Ct during the period of COVID-19 infection during the study period.
Measured: Up to 30 days(during case surveillance period)
Differences in the number of days of negative RT-PCR
Differences in the number of days of negative RT-PCR during the period of COVID-19 infection during the study period.
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 posted27 Dec 2022
- Study start30 Oct 2022
- Primary completion31 Dec 2022
- Study completion31 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuo Zhang, Principal investigator, Inner Mongolia Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664919
- Sponsor's protocol ID
- PRO-SA58-0001
- Status last verified
- Dec 2022
- First submitted
- 23 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
- Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel：An Open-label, Blank-controlled Study
- ClinicalTrials.gov ID
- NCT05664919
- Acronym / sponsor ID
- PRO-SA58-0001
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 27 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 an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.
Detailed description
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.A total of 7000 medical personnel will be involved in this study: 3500 will use SA58 Nasal Spray in the drug group, and 3500 not use SA58 Nasal Spray in the blank control group. The medication is self-administered intranasally 1~2 times per day with an interval of 6 hours for about 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug group | Experimental | Drug: SA58 Nasal Spray3500 participants will use SA58 Nasal Spray in drug group. |
| Blank control group | No intervention | –3500 participants won't be given medication in blank control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical staff working in the designated COVID-19 hospitals and Fangcang shelter hospitals (alternate care sites) of COVID-19 cases in Hohhot;
- Subjects were 18 years of age and older and in good health;
- Subjects volunteered to use COVID-19 neutralizing antibody nasal spray.
Key exclusion criteria (4 listed)
- Previous history of severe allergies or sensitivity to inhaled allergens;
- Women were pregnant or breastfeeding;
- Subjects were unable to cooperate with nasal spray inhalation;
- Other conditions for which medication was not appropriate.
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 | Drug group |
Primary outcome
COVID-19 infection rates
Time frame: Up to 30 days(during case surveillance period)
COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period.
4 secondary outcomes
Infection rates of asymptomatic and symptomatic COVID-19 patients
Time frame: Up to 30 days(during case surveillance period)
Incidence of mild, normal, severe, and critical COVID-19 cases
Time frame: Up to 30 days(during case surveillance period)
The peak Ct value
Time frame: Up to 30 days(during case surveillance period)
Differences in the number of days of negative RT-PCR
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.
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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.
Shuo Zhang principal investigator
Inner Mongolia Fourth 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 4 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. 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?
COVID-19 infection rates (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.