Mild to Moderate COVID-19Phase 2NCT05941793
A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients
A Phase 2 study testing MBS-COV in people with Mild to Moderate COVID-19, run by Oneness Biotech Co., Ltd. at 5 sites in 2 countries.
Trial summary
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants with Mild to Moderate COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate COVID-19
- What is being tested?
- MBS-COV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 11 Sep 2023to 12 Aug 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults who are 18 and above.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
- Both male and female participants and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential from study entry to 3 months after the last day of treatment (excluding women who are not of childbearing potential and men who have been sterilized).
- Participants should be willing to cooperate and able to participate in this study, comply with all protocol requirements, and sign an informed consent.
- Current non-smokers and those who have not smoked within the last 3 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.
- Confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen collected within 3 days prior to administration.
- Initial onset of signs/symptoms attributable to COVID-19 within 3 days prior to D1 administration and at least 1 of the specified signs/symptoms attributable to COVID-19 present on baseline
- Participants with mild or moderate COVID-19.
Who cannot join
- Participants who are judged by investigator maybe progressed to severe/critical COVID-19 or need to hospitalization prior to randomization.
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300 mmHg, respiratory rate ≥30 per minute, heart rate ≥125 per minute
- Participants infected with COVID-19 within 3 months before screening.
- Participants treated with SARS-CoV-2 monoclonal antibodies, antiviral for cure or prevent COVID-19 within 30 days.
- Participants who have received COVID-19 or non-COVID-19 vaccines or human COVID-19 immunoglobulin or convalescent plasma within 3 months before screening, or who plan to receive vaccine (including COVID-19 vaccine booster) during the study.
- Participants who have received systemic or inhaled steroid drugs to cure COVID-19 within 30 days before screening.
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- Participants who participate in other clinical trials and use other drugs in the investigation within 1 month or 5 half-life (whichever is longer) before screening.
- Participants with known allergic reactions to the study drug or its excipients.
- The participant has any nasopharyngeal abnormality that may have interfered with nasal absorption, distribution, or study-related evaluations of signs or symptoms
- Participants who have an acute sinusitis, a history of active allergic rhinitis (AR), history of perennial allergic rhinitis (PAR), or current seasonal allergic rhinitis (SAR), or recent viral rhinitis within 2 weeks prior to administration.
- As reported by the participant has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the participant and might interfere with the study conduct and results interpretation.
- Participants who have a history of other malignant tumors within 2 years before enrollment, except for skin basal cell carcinoma, skin squamous cell carcinoma, and carcinoma in situ that have undergone possible curative treatment and have not recurred within 5 years after the start of treatment.
- Participants suspected or diagnosed with active systemic infection, such as bacteria, fungi, viruses or other infections (except COVID-19 infection), or with diseases that the investigator judges will affect the evaluation of the study endpoint.
- Participants who have a known history of hepatitis C virus (HCV), human immunodeficiency virus (HIV), or active HBV infection (if the subject has a history of hepatitis B or has been positive for hepatitis B surface antigen in the past, but the liver function at the baseline period don't meets the exclusion criteria, and the investigator judges that the subject is in a stable period, the subject can be enrolled), or a positive test result for hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at screening.
- Participants with moderate or severe liver disease or kidney disease. And the results of laboratory tests during screening period meet one of the following indicators:
- AST or ALT level ≥3 × ULN;
- Total bilirubin ≥2 × ULN (≥3 × ULN for Gilbert's syndrome);
- Total WBC 2,500/mm3 or absolute neutrophil count <1500/mm3.
- eGFR < 30 mL/min, calculated by CKD-EPI formula.
- Platelet count < 80,000/mm3
- Ventilatory dysfunction or inability to use a nebulizer with a face mask.
- Females who are pregnant or breastfeeding.
- Any other situation that, judged by the investigator, may affect the subject to provide informed consent or to comply with the study protocol, or may affect the study results or their own safety.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Taiwan4 sites
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Municipal Wanfang Hospital
Taipei
United States1 site
Velocity Clinical Research
Salt Lake City, Utah, 84088
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants With Mild to Moderate COVID-19
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants with Mild to Moderate COVID-19
- Conditions
- Mild to Moderate COVID-19
- Being tested
- MBS-COV, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBS-COVDrug
MBS-COV for inhalation
PlaceboDrug
Placebo for inhalation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | low dosage of IP Receives: Drug: MBS-COV |
| Cohort 2 | Experimental | high dosage of IP Receives: Drug: MBS-COV |
| Cohort 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events,and Serious Adverse Events (SAEs)
Measured: 2 months
Secondary outcomes (10)
Time (days) to sustained alleviation of all targeted signs/symptoms through Day 28.
Measured: 28 days
Time (days) to sustained resolution of all targeted signs/symptoms through Day 28
Measured: 28 days
Proportion of participants with sustained alleviation of all targeted signs/symptoms through Day 60.
Measured: 60 days
Proportion of participants with sustained resolution of all targeted signs/symptoms through Day 60.
Measured: 60 days
Time (days) to sustained alleviation of Shortness of breath through Day 28.
Measured: 28 days
Time (days) to sustained resolution of Shortness of breath through Day 28.
Measured: 28 days
Time (days) to sustained alleviation of each sign/symptom through Day 28.
Measured: 28 days
Time (days) to sustained resolution of each sign/symptom through Day 28.
Measured: 28 days
Proportion of participants with sustained alleviation of each sign/symptom through Day 60.
Measured: 60 days
Proportion of participants with sustained resolution of each sign/symptom through Day 60.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start11 Sep 2023
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941793
- Sponsor's protocol ID
- SNS812CLCT02
- Status last verified
- Sep 2024
- First submitted
- 11 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chen SY, Chang SY, Chang YC, Liu MC, Chen KY, Chang JH, Tseng WP, Lin CH, Wu JL, Chou PC, Ou TY, Hsu CW, Chou FY, Ho HJ, Yang JF, Yang CF, Chen YF, Lee KY, Lu W, Yang PC. Safety and antiviral activity of inhaled siRNA SNS812 for treatment of mild-to-moderate COVID-19: a phase 2 randomized trial. J Biomed Sci. 2026 Aug 14;33(1):83. doi: 10.1186/s12929-026-01284-5.
PubMed 42601614
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05941793
- Acronym / sponsor ID
- SNS812CLCT02
- Conditions
- Mild to Moderate COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 12 Jul 2023 (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.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants with Mild to Moderate COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: MBS-COVlow dosage of IP |
| Cohort 2 | Experimental | Drug: MBS-COVhigh dosage of IP |
| Cohort 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female adults who are 18 and above.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
- Both male and female participants and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential from study entry to 3 months after the last day of treatment (excluding women who are not of childbearing potential and men who have been sterilized).
- Participants should be willing to cooperate and able to participate in this study, comply with all protocol requirements, and sign an informed consent.
- Current non-smokers and those who have not smoked within the last 3 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.
Key exclusion criteria (23 listed)
- Participants who are judged by investigator maybe progressed to severe/critical COVID-19 or need to hospitalization prior to randomization.
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300 mmHg, respiratory rate ≥30 per minute, heart rate ≥125 per minute
- Participants infected with COVID-19 within 3 months before screening.
- Participants treated with SARS-CoV-2 monoclonal antibodies, antiviral for cure or prevent COVID-19 within 30 days.
- Participants who have received COVID-19 or non-COVID-19 vaccines or human COVID-19 immunoglobulin or convalescent plasma within 3 months before screening, or who plan to receive vaccine (including COVID-19 vaccine booster) during the study.
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 |
|---|---|---|
| MBS-COVMBS-COV for inhalation | Drug | Cohort 1, Cohort 2 |
| PlaceboPlacebo for inhalation | Drug | Cohort 3 |
Primary outcome
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events,and Serious Adverse Events (SAEs)
Time frame: 2 months
10 secondary outcomes
Time (days) to sustained alleviation of all targeted signs/symptoms through Day 28.
Time frame: 28 days
Time (days) to sustained resolution of all targeted signs/symptoms through Day 28
Time frame: 28 days
Proportion of participants with sustained alleviation of all targeted signs/symptoms through Day 60.
Time frame: 60 days
Proportion of participants with sustained resolution of all targeted signs/symptoms through Day 60.
Time frame: 60 days
Time (days) to sustained alleviation of Shortness of breath through Day 28.
Time frame: 28 days
Time (days) to sustained resolution of Shortness of breath through Day 28.
Time frame: 28 days
Time (days) to sustained alleviation of each sign/symptom through Day 28.
Time frame: 28 days
Time (days) to sustained resolution of each sign/symptom through Day 28.
Time frame: 28 days
Proportion of participants with sustained alleviation of each sign/symptom through Day 60.
Time frame: 60 days
Proportion of participants with sustained resolution of each sign/symptom through Day 60.
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42601614Chen SY, Chang SY, Chang YC, Liu MC, Chen KY, Chang JH, Tseng WP, Lin CH, Wu JL, Chou PC, Ou TY, Hsu CW, Chou FY, Ho HJ, Yang JF, Yang CF, Chen YF, Lee KY, Lu W, Yang PC. Safety and antiviral activity of inhaled siRNA SNS812 for treatment of mild-to-moderate COVID-19: a phase 2 randomized trial. J Biomed Sci. 2026 Aug 14;33(1):83. doi: 10.1186/s12929-026-01284-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBS-COV in people with Mild to Moderate COVID-19, run by Oneness Biotech Co., Ltd. at 5 sites in 2 countries.
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 8 inclusion and 23 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan, United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events,and Serious Adverse Events (SAEs) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941793, which also lists 1 linked publication.
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 19 Sep 2024.