S-892216 for Coronavirus

No longer recruiting at 56 trial locations
SC
Overseen ByShionogi Clinical Trials Administrator Clinical Support Help Line
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called S-892216, a potential antiviral drug, to determine its effectiveness against COVID-19, the illness caused by the coronavirus. Researchers aim to assess how well this drug combats the virus. Participants will receive one of three different doses of S-892216 or a placebo (a pill with no active medicine) to compare the effects. Individuals who have recently shown symptoms of COVID-19 and have a confirmed positive test may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot receive any other COVID-19-specific treatments during the study.

Is there any evidence suggesting that S-892216 is likely to be safe for humans?

Research shows that S-892216 is a promising treatment under study for COVID-19. Early studies have found no safety concerns with this treatment. Specifically, the first dose in an early trial presented no safety issues, suggesting it is well-tolerated in humans so far. This treatment works by blocking a key enzyme the virus needs to multiply. While more research is needed to fully understand its safety, early results are encouraging.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for coronavirus, which often rely on antiviral drugs or monoclonal antibodies, S-892216 is a novel medication that researchers are eagerly exploring. This investigational drug potentially offers a new mechanism of action, targeting the virus in a way that current treatments do not. Additionally, S-892216 is being tested in multiple doses, which could optimize its effectiveness and safety profile. Researchers are hopeful that this approach could lead to quicker, more effective management of coronavirus symptoms, making it a promising addition to the arsenal against this virus.

What evidence suggests that S-892216 might be an effective treatment for COVID-19?

Research has shown that S-892216 could be a promising treatment for COVID-19. Studies have found that it blocks a key enzyme the virus needs to multiply. In lab tests, S-892216 demonstrated strong antiviral effects, effectively stopping the virus at very low doses. It also proved effective against different strains of the virus, including those resistant to other treatments. This trial will evaluate different doses of S-892216 to determine its effectiveness as an antiviral medication for COVID-19.13678

Are You a Good Fit for This Trial?

This trial is for individuals weighing at least 40 kg with confirmed COVID-19, experiencing symptoms within the last 72 hours. They must be able to maintain an electronic diary and agree not to join other COVID-19 treatment studies during this period. Women of childbearing potential need a negative pregnancy test, and all participants should use contraception according to local guidelines.

Inclusion Criteria

I weigh at least 40 kilograms.
I have taken a pregnancy test in the last 24 hours and it was negative.
I agree not to join another COVID-19 study before day 28 or unless I'm hospitalized.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive S-892216 or placebo to assess antiviral effects

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • S-892216
Trial Overview The study aims to assess the antiviral effects of S-892216 on patients with COVID-19. Participants will either receive S-892216 or a placebo without knowing which one they're getting, in order to compare outcomes between the two groups fairly.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: S-892216: Dose 3Experimental Treatment1 Intervention
Group II: S-892216: Dose 2Experimental Treatment1 Intervention
Group III: S-892216: Dose 1Experimental Treatment2 Interventions
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials
122
Recruited
42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)

Citations

A Study of S-892216 in Participants With COVID-19The primary objective of this study is to investigate the antiviral effect of S-892216 in participants with coronavirus disease 2019 (COVID-19) due to ...
A Second-Generation of SARS-CoV-2 3CL Protease Inhibitor ...S-892216 is a reversible covalent 3CL pro inhibitor with highly potent antiviral activity and an EC 50 value of 2.48 nM against SARS-CoV-2 infected cells.
P-1079. In Vitro and in Vivo Antiviral Activity of S-892216, a ...Results. S-892216 showed high 3CLpro inhibitory activity (IC50 = 0.697 nmol/L) and exhibited in vitro antiviral activity against several SARS- ...
Shionogi Receives Award Through BARDA's Rapid ...In pre-clinical trials, S-892216 demonstrated a strong antiviral effect. S-892216 was discovered by Shionogi and its research and development ...
P-2041. In Vitro Resistance Profiling of S-892216, a Second ...These data suggest S-892216 might be effective if described ensitrelvir- and nirmatrelvir-resistant SARS-CoV-2 variants become relevant in the ...
Shionogi Expands its COVID-19 Product Portfolio by ...The first dose in this Phase 1 clinical trial was administered successfully and no safety concerns have been identified. S-892216 is a 3CL ...
Discovery of The Clinical Candidate S-892216S-892216 is a reversible covalent 3CL pro inhibitor with highly potent antiviral activity and an EC 50 value of 2.48 nM against SARS-CoV-2 infected cells.
COVID-19 PortfolioUSA. Product Name: S-892216 Long Acting Injectable for COVID-19 PrEP. Description: S-892216 is a small molecule inhibitor that blocks the main protease (Mpro) ...
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