What side effects are associated with this type of intervention?

Common treatments for COVID-19, particularly antivirals and immune modulators, have a range of side effects. Tocilizumab, an immune modulator, can cause constipation, diarrhea, nausea, anxiety, insomnia, hypertension, and superinfection. It should be used cautiously in immunocompromised individuals. Antiviral treatments, while not detailed in the context, generally may cause gastrointestinal issues, liver enzyme abnormalities, and allergic reactions. It is important to consult with healthcare providers to understand the specific risks and benefits of these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including antiviral and immune modulator drugs. Remdesivir, an antiviral, was one of the first to receive approval for treating hospitalized patients. Additionally, immune modulators like dexamethasone, a corticosteroid, have been approved for severe cases to reduce inflammation. Monoclonal antibodies, such as bamlanivimab and casirivimab/imdevimab, were also granted emergency use authorization for mild to moderate cases to prevent progression to severe disease. These treatments aim to either directly inhibit the virus or modulate the immune response to prevent excessive inflammation.

What other types of research exist?

Promising alternatives to SNS812 for COVID-19 treatment include: 1) Remdesivir, an antiviral approved for children and adults at risk of severe disease, which has shown efficacy in reducing hospitalization. 2) Molnupiravir, a nucleoside analogue available under EUA for high-risk nonpregnant adults. 3) Monoclonal antibodies such as tixagevimab/cilgavimab, which have been used for pre-exposure prophylaxis in immunocompromised patients. 4) Subcutaneous casirivimab and imdevimab, which have reduced symptomatic COVID-19 in early asymptomatic infections. These treatments offer various mechanisms of action and have been evaluated for safety and efficacy in different patient populations.

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Virus Therapy

SNS812 for COVID-19

Q: What is the mechanism of action of this treatment?

Common treatments for COVID-19 include antiviral agents and immune modulators. Antiviral treatments, such as remdesivir, work by inhibiting the replication of the virus, thereby reducing the viral load and helping the body to control the infection more effectively. Immune modulators, like dexamethasone, aim to modulate the body's immune response to prevent an overreaction that can lead to severe inflammation and tissue damage. These treatments are crucial for COVID-19 patients as they can either directly target the virus or manage the immune response, reducing complications and improving recovery outcomes.

Phase 2

Waitlist Available

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

Must not have

Participants who have a known history of hepatitis C virus (HCV), human immunodeficiency virus (HIV), or active HBV infection, or a positive test result for hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at screening

Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300 mmHg, respiratory rate ≥30 per minute, heart rate ≥125 per minute

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

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 check if the drug can reduce symptoms and help patients recover faster without causing serious side effects.

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.

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.

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

Select...

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.

Select...

I have mild or moderate COVID-19 symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history or positive test for HIV, HCV, or active HBV.

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My oxygen level is low, or I breathe very fast and my heart beats very quickly.

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I had COVID-19 within the last 3 months.

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I am not pregnant or breastfeeding.

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I do not have severe health conditions that could affect the study's medicine.

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I have moderate or severe liver or kidney disease.

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I have not received any COVID-19 or other vaccines, nor COVID-19 immunoglobulin or plasma in the last 3 months, and do not plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 2

~180

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 include antiviral agents and immune modulators. Antiviral treatments, such as remdesivir, work by inhibiting the replication of the virus, thereby reducing the viral load and helping the body to control the infection more effectively. Immune modulators, like dexamethasone, aim to modulate the body's immune response to prevent an overreaction that can lead to severe inflammation and tissue damage. These treatments are crucial for COVID-19 patients as they can either directly target the virus or manage the immune response, reducing complications and improving recovery outcomes.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.The potential insights of Traditional Chinese Medicine on treatment of COVID-19.