search
Back to results

A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients

Primary Purpose

Mild to Moderate COVID-19

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
MBS-COV
Placebo
Sponsored by
Oneness Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

low dosage of IP

high dosage of IP

Placebo

Outcomes

Primary Outcome Measures

The difference of SARS CoV-2 viral load change from baseline between MBS-COV and placebo at specified timepoints

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
October 17, 2023
Sponsor
Oneness Biotech Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05941793
Brief Title
A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oneness Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
low dosage of IP
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
high dosage of IP
Arm Title
Cohort 3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MBS-COV
Intervention Description
MBS-COV for inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for inhalation
Primary Outcome Measure Information:
Title
The difference of SARS CoV-2 viral load change from baseline between MBS-COV and placebo at specified timepoints
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reo Yang
Phone
02-2703-1098
Email
Reo.Yang@onenessbio.com.tw
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shey-Ying Chen
First Name & Middle Initial & Last Name & Degree
Shey-Ying Chen

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients

We'll reach out to this number within 24 hrs