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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of COVID-19, a respiratory infection caused by the SARS-CoV-2 virus. The trial will evaluate a new medication called S-217622, which is a type of drug known as a protease inhibitor. Protease inhibitors work by blocking a specific enzyme that the virus needs to multiply, potentially helping to reduce the severity of the infection. Participants in the study will receive either the S-217622 medication or a Placebo-B, which is a substance with no active ingredients, alongside the standard care they would normally receive in the hospital.

The purpose of this study is to determine if a 5-day treatment with S-217622 can improve the clinical outcomes for patients hospitalized with COVID-19. The study will involve patients who are admitted to the hospital with symptoms of a respiratory infection and have confirmed COVID-19. The trial will monitor participants over a period of 60 days to assess their recovery and overall health status. The main focus will be on how quickly patients recover, as well as their health condition at the end of the study period.

Throughout the study, researchers will also keep track of any serious health events or side effects that may occur. This will help ensure the safety of the participants and provide valuable information about the potential benefits and risks of using S-217622 as a treatment for COVID-19. The trial aims to provide insights into whether this new medication can be an effective addition to the current treatment options for hospitalized patients with COVID-19.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be asked to provide informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

    You must be at least 18 years old and have been admitted to the hospital with signs of a respiratory infection, confirmed as COVID-19.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either the S-217622 treatment or a placebo. A placebo is a tablet that looks like the treatment but does not contain the active substance.

    This process ensures that the trial results are unbiased and reliable.

  3. Step 3

    Treatment administration

    If assigned to the treatment group, you will receive S-217622 in the form of a tablet. The treatment lasts for 5 days.

    The medication is taken orally, meaning you will swallow the tablet.

  4. Step 4

    Monitoring and follow-up

    Your health will be monitored throughout the trial to assess your recovery and any side effects. This includes regular check-ups and assessments.

    The primary outcome measured is the Days to Recovery Scale over a period of 60 days. This scale tracks your recovery progress.

  5. Step 5

    Completion of trial

    At the end of the trial, your overall health and recovery status will be evaluated.

    The trial aims to determine if the S-217622 treatment improves clinical outcomes for patients hospitalized with COVID-19.

Who can join the trial?

6 criteria

  • Must be 18 years or older.
  • Must provide informed consent to participate in the trial. This means you understand the trial and agree to take part.
  • Must be admitted to the hospital or waiting for hospital admission with signs or symptoms of a respiratory infection.
  • Must have a confirmed SARS-CoV2 infection (the virus that causes COVID-19) by a test done within the last 14 days.
  • The onset of symptoms related to the SARS-CoV2 infection must have started within 14 days before joining the trial.
  • Must be hospitalized for COVID-19 management, showing signs or symptoms that suggest a lower respiratory tract infection. This means the infection affects the lungs or airways.

Who cannot join the trial?

7 criteria

  • Patients who are not hospitalized for the management of COVID-19.
  • Patients who are not adults. The study is for adults only.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial that could interfere with this study.
  • Patients who have a known allergy or sensitivity to the study medication or its ingredients.
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Investigated drugs

S-217622 is a medication being tested in this clinical trial. It is a protease inhibitor, which means it works by blocking a specific enzyme that the virus needs to multiply. By inhibiting this enzyme, the medication aims to reduce the amount of virus in the body, potentially leading to better outcomes for patients who are hospitalized with COVID-19. The trial is investigating whether a 5-day treatment with this medication, in addition to standard care, can improve the health of patients compared to those who do not receive it.

What is already known about the treatment

Shionogi Protease Inhibitor (S-217622) – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating COVID-19 in hospitalized patients. It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for S-217622 is to improve clinical outcomes for patients with COVID-19. At the molecular level, it works by inhibiting a specific enzyme called protease, which is essential for the virus to replicate and spread in the body. This medication is classified as a protease inhibitor, a type of drug that blocks the activity of proteases, thereby hindering the virus's ability to multiply.

Investigated diseases

COVID-19 – COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can start with mild symptoms such as fever, cough, and fatigue, but it may progress to more severe conditions like difficulty breathing and pneumonia. In some cases, it can lead to acute respiratory distress syndrome (ARDS) and multi-organ failure. The progression of the disease varies widely among individuals, with some experiencing mild symptoms and others developing severe complications. The course of the illness can last from a few days to several weeks, depending on the severity and the individual's health condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501020-19-01Protocol codeINSIGHT 018Estimated enrolment1 520 patientsSponsorUniversity Of Minnesota

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