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) - Immune Modulation Strategy Trial
This important study, called STRIVE, is looking for better ways to treat adults who are in hospital with COVID-19. We want to see if a medicine called Orencia can help people recover more quickly. Some patients will receive Orencia, while others will receive a dummy treatment (like plain water given through a drip) that looks the same. This allows us to fairly compare how well Orencia works and if it has any unwanted effects, compared to standard care. We'll be closely watching how quickly people get better and checking for any serious problems. This kind of research helps doctors find the most effective treatments for serious infections like COVID-19.
At a glance
What is this study about?
This study, called STRIVE, is designed to find better ways to help adults who are very unwell in hospital because of COVID-19. When people get a severe respiratory infection, their immune system can sometimes overreact, which can make them even sicker. We're investigating if a specific medicine, called Orencia, can help to calm this overactive immune response and help patients recover.
To make sure our findings are reliable, we are comparing Orencia with a 'dummy' treatment, which is just sterile salt water given through a drip. This looks exactly like the real medicine but doesn't contain any active drug. Patients will be randomly assigned to receive either Orencia or the dummy treatment. This is a common and important way to test new medicines, as it helps us see if any improvements are genuinely due to the drug itself rather than other factors.
The main thing we'll be looking at is how quickly patients recover over 60 days. We call this the "Days to Recovery Scale". This scale helps us track improvements, but also notes if someone doesn't recover well or sadly passes away. We'll also be checking for serious side effects and how many patients need breathing support or die. The aim is to understand if Orencia can lead to a quicker and more complete recovery for people seriously ill with COVID-19.
Key takeaways
- Tests a medicine called Orencia for adults in hospital with COVID-19.
- Compares Orencia to a dummy treatment to see if it helps recovery.
- Aims to reduce severe illness and speed up recovery.
- Monitors recovery and side effects for up to 60 days.
- Your safety and well-being are the top priority throughout the study.
Who may be eligible?
This study is open to adults aged 18 years and older who are currently in hospital with COVID-19. Both men and women can take part. To be suitable, you would need to meet certain other medical criteria that your doctor would check.
Your doctor will carefully review your medical history and current health to make sure this study is right and safe for you. They will explain exactly why you might or might not be able to join. Your safety is the most important thing.
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?
- Are you able to provide consent for yourself, or can a family member provide it for you?
- Do you meet other specific medical requirements (which your doctor would check)?
What does participation involve?
If you decide to take part, you will be in the study while you are in hospital and then for up to 60 days after that. You would receive either the study medicine (Orencia) or the dummy treatment through a drip. The doctors and nurses looking after you would know what you are receiving, but you might not be told, in order to keep the study fair.
Throughout the study, the medical team will regularly check on your health and recovery. They will take your temperature, check your breathing, and ask you questions about how you are feeling. They will also take blood tests and keep track of any changes in your condition or any side effects you might experience. This allows us to accurately measure if the treatment is working and if it is safe. After you leave the hospital, there will be follow-up checks to monitor your recovery for the full 60 days.
Potential risks and benefits
Locations (9)
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Common questions
What is Orencia and how does it work?
Orencia is a medicine that aims to calm down an overactive immune system, which can sometimes happen during severe infections like COVID-19.
What is a 'dummy treatment'?
A dummy treatment looks exactly like the real medicine but contains no active drug, like plain sterile water. It helps us compare the real medicine fairly.
How long will I be in the study?
You'll be in the study while you're in hospital and then we'll follow your recovery for a total of 60 days.
Will I know if I'm getting the real medicine or the dummy treatment?
You might not be told during the study, to keep the results fair. Your medical team will know, and your safety is always their priority.
Can I leave the study if I change my mind?
Yes, you are completely free to leave the study at any time, for any reason, and it won't affect your ongoing medical care.
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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