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

NCT05941793 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SNS812CLCT02
• Study Type: interventional
• Target: 135
• Locations: 2 countries
• Sites: 5

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

Conditions

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (1)

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

  2 months

Secondary Outcomes (10)

• 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

low dosage of IP

Drug: MBS-COV

Cohort 2

EXPERIMENTAL

high dosage of IP

Drug: MBS-COV

Cohort 3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MBS-COV DRUG

MBS-COV for inhalation

Cohort 1; Cohort 2

Placebo DRUG

Placebo for inhalation

Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (5)

Velocity Clinical Research

Salt Lake City, Utah, 84088, United States

Location

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

New Taipei City, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 12, 2023
• Study Start: September 11, 2023
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TW (4); US (1)