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A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05941793•Oneness Biotech Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+12 more criteria

Locations (5)

Velocity Clinical Research

Salt Lake City, Utah, United States

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Key Dates

Start Date

September 11, 2023

Primary Completion Date

August 12, 2024

Completion Date

August 12, 2024

Last Updated

September 19, 2024

Enrollment

135

ACTUAL participants

Conditions

Mild to Moderate COVID-19

Interventions

MBS-COV

DRUG

Placebo

DRUG

JT001 (VV116) for the Early Treatment of COVID-19

NCT05242042

Mild to Moderate COVID-19

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TERMINATEDPHASE2/PHASE3

Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo

NCT04521296

Mild to Moderate COVID-19

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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