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(6E)-6-[(6-Chloro-2-Methyl-2H-Indazol-5-Yl)Imino]-3-[(1-Methyl-1H-1,2,4-Triazol-3-Yl)Methyl]-1-[(2,4,5-Trifluorophenyl)Methyl]-1,3,5-Triazinane-2,4-Dione

This article discusses a clinical trial investigating the use of S-217622, a new protease inhibitor developed by Shionogi, for the treatment of hospitalized COVID-19 patients. The study aims to determine if a 5-day treatment course with S-217622, compared to a placebo, can improve clinical outcomes when given alongside standard care. This multicenter, adaptive, randomized, controlled trial is part of the STRIVE platform, which focuses on evaluating strategies and treatments for respiratory infections and viral emergencies.

Table of Contents

What is S-217622?

S-217622 is an investigational drug being studied as a potential treatment for hospitalized patients with COVID-19. It is also known by its chemical name, which is quite long and complex: (6E)-6-[(6-CHLORO-2-METHYL-2H-INDAZOL-5-YL)IMINO]-3-[(1-METHYL-1H-1,2,4-TRIAZOL-3-YL)METHYL]-1-[(2,4,5-TRIFLUOROPHENYL)METHYL]-1,3,5-TRIAZINANE-2,4-DIONE. This medication is being developed by Shionogi B.V., a pharmaceutical company.[1]

How does S-217622 work?

S-217622 is classified as a protease inhibitor. Protease inhibitors work by blocking certain enzymes that viruses need to replicate. In the case of COVID-19, S-217622 is designed to interfere with the virus’s ability to multiply in the body, potentially reducing the severity and duration of the illness.[1]

Clinical Trial Overview

A clinical trial called STRIVE (Strategies and Treatments for Respiratory Infections & Viral Emergencies) is currently underway to evaluate the safety and efficacy of S-217622 in hospitalized COVID-19 patients. The main goal of this trial is to determine if a 5-day treatment course with S-217622, compared to a placebo, can improve clinical outcomes for patients hospitalized due to COVID-19 when given alongside standard care.[1]

The primary outcome being measured is called the “Days to Recovery Scale” (DRS-60), which is assessed over 60 days. This scale combines information about how quickly patients recover, whether they remain unrecovered, or if they unfortunately pass away.[1]

Who can participate in the trial?

The trial has specific criteria for who can participate. Some key inclusion criteria are:

  • Adults who are hospitalized with signs and/or symptoms of a respiratory infection
  • Confirmed SARS-CoV-2 infection (the virus that causes COVID-19) within the past 14 days
  • Onset of COVID-19 symptoms within 14 days before entering the study

However, some people cannot participate in the trial. Exclusion criteria include:

  • Severe kidney problems
  • Pregnancy or breastfeeding
  • Severe liver problems
  • Inability to take tablets by mouth
  • Very severe illness with a life expectancy of less than 48 hours

These criteria help ensure the safety of participants and the reliability of the study results.[1]

How is S-217622 administered?

In the trial, S-217622 is given as tablets taken by mouth. The treatment course is as follows:

  1. On the first day (Day 0), patients take a loading dose of 375 mg (3 tablets of 125 mg each)
  2. For the next four days (Days 1-4), patients take 125 mg (1 tablet) daily

This 5-day course is designed to quickly achieve an effective level of the drug in the body and maintain it over the treatment period.[1]

Potential Benefits

While the effectiveness of S-217622 is still being studied, the researchers hope to see several potential benefits, including:

  • Faster recovery from COVID-19
  • Reduced risk of death
  • Lower likelihood of needing invasive mechanical ventilation (a breathing machine)
  • Overall improvement in clinical outcomes for hospitalized COVID-19 patients

It’s important to note that these potential benefits are still being investigated, and the trial results will provide more information about the drug’s effectiveness.[1]

Safety Considerations

As with any investigational drug, safety is a top priority. The trial is closely monitoring for any side effects or adverse events. Some safety measures include:

  • Regular monitoring of participants’ health throughout the study
  • Tracking of serious adverse events, anticipated clinical events, and moderate to severe side effects
  • Exclusion of individuals with certain medical conditions that might increase their risk of complications

The researchers will use this information to assess the overall safety profile of S-217622 and determine if its potential benefits outweigh any risks.[1]

In conclusion, S-217622 represents a promising area of research in the fight against COVID-19. While it’s still in the investigational stage, this clinical trial will provide valuable information about its safety and effectiveness in treating hospitalized COVID-19 patients. As always, it’s important to rely on approved treatments and follow guidance from healthcare professionals while we await the results of this and other ongoing studies.

Aspect Details
Drug Name S-217622 (Protease Inhibitor)
Manufacturer Shionogi B.V.
Trial Design Multicenter, adaptive, randomized, controlled trial
Target Population Hospitalized adults with COVID-19
Treatment Duration 5 days
Dosing Regimen 375 mg loading dose, followed by 125 mg daily for 4 days
Primary Outcome Days to Recovery Scale over 60 days (DRS-60)
Key Secondary Outcomes Mortality, time to recovery, safety measures
Administration Route Oral
Follow-up Period 60 days

FAQ

  • What is S-217622 and how does it work? S-217622 is a novel protease inhibitor developed by Shionogi. It works by inhibiting a specific enzyme that the SARS-CoV-2 virus needs to replicate, potentially slowing down the progression of COVID-19 in infected patients.
  • Who is eligible to participate in this clinical trial? Eligible participants are hospitalized adults with confirmed SARS-CoV-2 infection, showing symptoms of lower respiratory tract infection within 14 days before randomization. They must be able to provide informed consent and take the medication orally.
  • What is the dosing regimen for S-217622 in this trial? Participants receive a loading dose of 375 mg (3 tablets) on the day of randomization, followed by 125 mg (1 tablet) daily for the next four days, totaling a 5-day treatment course.
  • What is the primary outcome measure for this trial? The primary outcome is the 'Days to Recovery Scale' assessed over 60 days (DRS-60), which combines time to recovery with non-recovered clinical state and death into an ordinal outcome.
  • Are there any specific exclusion criteria for this trial? Yes, some key exclusion criteria include severe kidney or liver problems, pregnancy, breastfeeding, inability to take oral medication, and use of medications that may interact with S-217622. Patients expected to be discharged within 24 hours or those receiving end-of-life care are also excluded.

Ongoing Clinical Trials on (6E)-6-[(6-Chloro-2-Methyl-2H-Indazol-5-Yl)Imino]-3-[(1-Methyl-1H-1,2,4-Triazol-3-Yl)Methyl]-1-[(2,4,5-Trifluorophenyl)Methyl]-1,3,5-Triazinane-2,4-Dione

  • Study on the Effects of S-217622 for Adults Hospitalized with COVID-19

    Not recruiting

    3 1
    Investigated drugs:
    Denmark Germany Greece Ireland Poland Spain

Glossary

  • Protease Inhibitor: A type of antiviral drug that prevents viruses from multiplying by blocking a specific enzyme (protease) that the virus needs to replicate.
  • SARS-CoV-2: The virus responsible for causing COVID-19 (Coronavirus Disease 2019).
  • Randomized Controlled Trial: A type of scientific experiment where participants are randomly assigned to different treatment groups to compare the effectiveness of interventions.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect, used as a control in clinical trials.
  • Standard Care: The typical treatment or care given to patients with a particular condition, which may vary depending on the hospital and current medical guidelines.
  • Ordinal Outcome: A type of measurement where the possible results are ordered or ranked, but the exact differences between categories may not be known or equal.
  • Glomerular Filtration Rate (GFR): A measure of how well the kidneys are filtering waste from the blood, used to assess kidney function.
  • Invasive Mechanical Ventilation: A method of artificial breathing support where a machine pumps air into the lungs through a tube inserted into the windpipe.
  • Adverse Event: Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Loading Dose: A higher initial dose of a medication given at the beginning of treatment to quickly achieve an effective concentration in the body.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-s-217622-for-adults-hospitalized-with-covid-19/