A Multicenter, Adaptive, Randomized, Controlled Trial Platform to Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections: Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) - Shionogi Protease Inhibitor (S-217622)
This research study, called STRIVE, is testing a new medication named S-217622 for people who are in hospital because of COVID-19. The main goal is to find out if this medication is safe and effective in helping patients recover. Participants will be given either the new medication or a placebo (a dummy treatment with no active ingredients). Researchers will carefully track how quickly people recover over 60 days, as well as if they become sicker or, sadly, pass away. They will also look at other important things like how many people need breathing machines, and any side effects the medication might cause. This is a large study involving many hospitals.
At a glance
What is this study about?
This study, called STRIVE, is investigating a new treatment named S-217622 for patients who are seriously ill with COVID-19 and need hospital care. The main purpose is to see if this new medication can help people get better more quickly and safely. It's a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available, if it proves successful.
To understand if the treatment works, some patients will receive the new medication and others will receive a 'placebo', which looks identical but doesn't contain any active drug. This is important to ensure that any improvements seen are truly due to the S-217622 and not just other care. The researchers will closely follow patients for up to 60 days to see how their recovery progresses.
The main thing the study will measure is how quickly people recover. They will use a special scale that looks at how many days it takes for someone to feel better, or if they unfortunately don't recover, or even pass away. They will also check on other important health outcomes, like whether the treatment reduces the number of people who need help breathing with a machine, and they will carefully monitor for any side effects or other safety concerns.
Key takeaways
- Tests a new COVID-19 treatment called S-217622.
- Looks at how quickly people recover from COVID-19 in hospital.
- Compares S-217622 to a 'dummy' treatment (placebo).
- Monitors for safety and side effects carefully.
- Participation lasts about 60 days.
Who may be eligible?
This study is looking for adults aged 18 and over who are currently in hospital because of a COVID-19 infection. They are open to including both men and women.
There might be other health conditions or medications that could prevent someone from joining the study, to make sure it's safe for everyone involved. The study team would carefully review each person's medical history to see if they are a good fit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you currently in hospital because of COVID-19?
- Do you understand what a placebo is?
- Are you comfortable with being followed up for 60 days?
What does participation involve?
If you decide to take part, you would be given either the study medication (S-217622) or a placebo, which looks like the medication but has no active ingredients. You wouldn't know which one you are receiving. The study team would monitor your health very closely while you are in the hospital. This would involve regular checks of your symptoms, taking blood samples, and other assessments.
After you leave the hospital, you would continue to be followed up for a total of 60 days to track your recovery. This might involve phone calls or clinic visits. The total duration of your active participation in the study, from receiving the treatment to the final follow-up, would be around 60 days.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedDenmark
- —UnverifiedPoland
- —UnverifiedIreland
Common questions
What is the new medication called?
The new medication being tested in this study is called S-217622.
What is a placebo?
A placebo is a dummy treatment that looks just like the real medication but doesn't contain any active ingredients. It helps researchers compare the effects of the new drug.
How long will the study last for me?
If you join the study, you would be followed for up to 60 days after starting the treatment.
Can I choose which treatment I get?
No, you cannot choose. Participants are randomly assigned to receive either the S-217622 or the placebo.
What kind of hospital patients can join?
The study is for adults aged 18 and over who are currently in hospital with COVID-19.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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