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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Mild to Moderate COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: MBS-COV

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Municipal Wanfang Hospital
  • Taipei, Taiwan
    • Taipei Medical University Hospital
• United States
  • Utah
    • Salt Lake City, Utah, United States, 84088
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  1. AST or ALT level ≥3 × ULN;
  2. Total bilirubin ≥2 × ULN (≥3 × ULN for Gilbert's syndrome);
  3. Total WBC 2,500/mm3 or absolute neutrophil count <1500/mm3.
  4. eGFR < 30 mL/min, calculated by CKD-EPI formula.
  5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; low dosage of IP	Drug: MBS-COV; MBS-COV for inhalation
Experimental: Cohort 2; high dosage of IP	Drug: MBS-COV; MBS-COV for inhalation
Placebo Comparator: Cohort 3; Placebo	Drug: Placebo; Placebo for inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events,and Serious Adverse Events (SAEs)	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The difference of SARS CoV-2 viral load change from baseline between MBS-COV and placebo at specified timepoints measured by reverse transcription polymerase chain reaction (RT-PCR)	28 days
Time (Days) to reach clearance of SARS-CoV-2 viral RNA in RT-PCR.	28 days
Proportion of participants to reach clearance of SARS-CoV-2 viral RNA over the time.	28 days
Time (days) to sustained alleviation of all signs/symptoms.	60 days
Time (days) to sustained resolution of all signs/symptoms.	60 days
Proportion of participants with sustained alleviation of all signs/symptoms.	60 days
Proportion of participants with sustained resolution of all signs/symptoms.	60 days

Collaborators and Investigators

• Sponsor: Oneness Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SNS812CLCT02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No