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

Oneness Biotech Co., Ltd.5 sites in 2 countries135 target enrollmentSeptember 11, 2023

ConditionsMild to Moderate COVID-19

InterventionsPlacebo MBS-COV

DrugsMBS-COV Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Mild to Moderate COVID-19
Sponsor: Oneness Biotech Co., Ltd.
Enrollment: 135
Locations: 5
Primary Endpoint: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events,and Serious Adverse Events (SAEs)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 11, 2023

End Date

November 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oneness Biotech Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

Cohort 3

Placebo

Intervention: Placebo

Cohort 1

low dosage of IP

Intervention: MBS-COV

Cohort 2

high dosage of IP

Intervention: MBS-COV

Outcomes

Primary Outcomes

Incidence and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events,and Serious Adverse Events (SAEs)

Time Frame: 2 months

Secondary Outcomes

Time (days) to sustained alleviation of all targeted signs/symptoms through Day 28.(28 days)
Time (days) to sustained resolution of all targeted signs/symptoms through Day 28(28 days)
Proportion of participants with sustained alleviation of all targeted signs/symptoms through Day 60.(60 days)
Proportion of participants with sustained resolution of all targeted signs/symptoms through Day 60.(60 days)
Time (days) to sustained alleviation of Shortness of breath through Day 28.(28 days)
Time (days) to sustained resolution of Shortness of breath through Day 28.(28 days)
Time (days) to sustained alleviation of each sign/symptom through Day 28.(28 days)
Time (days) to sustained resolution of each sign/symptom through Day 28.(28 days)
Proportion of participants with sustained alleviation of each sign/symptom through Day 60.(60 days)
Proportion of participants with sustained resolution of each sign/symptom through Day 60.(60 days)