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Virus Therapy

Cohort 2 for Coronavirus Disease

Phase 2

Recruiting

Research Sponsored by Oneness Biotech Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current non-smokers and those who have not smoked within the last 3 months

Both male and female participants and their partners of childbearing potential must agree to use two medically accepted methods of contraception or must practice complete abstinence from intercourse of reproductive potential from study entry to 3 months after the last day of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 month

Awards & highlights

Study Summary

This trial is testing a new drug called SNS812 to see if it can help people with mild to moderate COVID-19. The study will compare the effects of the drug to a placebo to see

Who is the study for?

Adults over 18 with a BMI of 18-32, not smoking for at least 3 months, and with confirmed mild to moderate COVID-19 can join. They must use two forms of contraception or abstain from sex if they can have children. Participants need to agree to all study rules and give informed consent.Check my eligibility

What is being tested?

The trial is testing SNS812's effectiveness against COVID-19 compared to a placebo. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug or placebo until after the results are collected.See study design

What are the potential side effects?

While specific side effects for SNS812 aren't listed here, common ones in trials like this may include nausea, headache, fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not smoked in the last 3 months.

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My partner and I agree to use two forms of birth control or abstain from sex until 3 months after my treatment ends.

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I started showing COVID-19 symptoms less than 3 days ago and still have symptoms.

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I have mild or moderate COVID-19 symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2Experimental Treatment1 Intervention

high dosage of IP

Group II: Cohort 1Experimental Treatment1 Intervention

low dosage of IP

Group III: Cohort 3Placebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MBS-COV

2022

Completed Phase 1

~50

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oneness Biotech Co., Ltd.Lead Sponsor

18 Previous Clinical Trials

1,104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cohort 2 received the official authorization from the Food and Drug Administration?

"The safety assessment for Cohort 2 in this trial has been graded at a level of 2 by our experts at Power. This rating is based on available safety data, as there is no evidence supporting efficacy yet due to the Phase 2 nature of the study."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, details on clinicaltrials.gov highlight the current recruitment status of this investigation. Initially shared on September 11th, 2023, and last modified on February 26th, 2024, the trial aims to enroll a total of 135 participants across three designated sites."

Answered by AI

Is the enrollment phase of this medical study currently ongoing?

"Affirmative. The details available on clinicaltrials.gov indicate an ongoing search for eligible participants in this investigation. Originally shared on September 11, 2023, the most recent update was made on February 26, 2024. A total of 135 individuals are sought across three designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05941793.