RecruitingPHASE2INTERVENTIONAL

OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial

This study, called 'OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients,' is for people with COVID-19 and a weakened immune system. It aims to find the best way to treat mild or asymptomatic COVID-19 in this group. Researchers are comparing two main things: whether taking Paxlovid for 10 days is better than 5 days, and whether combining Paxlovid with another medicine called Veklury works better than Paxlovid alone. They want to see if these changes can reduce the amount of virus in the body more effectively. The study is taking place in France and Switzerland and involves about 256 patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

ANRS, Emerging Infectious Diseases

Enrolment target

256

Start

27 Apr 2023

Estimated completion

30 Jun 2027

COVID-19 Immunodeficiency

What is this study about?

This study is specifically designed for people who have COVID-19 and also have a weakened immune system. Having a weakened immune system can make it harder for your body to fight off infections like COVID-19, and the virus might stay in your system longer or cause more severe problems. The researchers want to find the most effective treatment plan to help these patients recover quickly and fully.

The main goal of the study is to test if making changes to current antiviral treatments can improve how well they work. They are looking at two main approaches. Firstly, they want to see if taking a common antiviral medicine, Paxlovid, for a longer period (10 days instead of the usual 5 days) helps to clear the virus better. Secondly, they are investigating whether using Paxlovid together with another antiviral medicine called Veklury (also known as remdesivir) is more effective than just taking Paxlovid by itself.

By comparing these different treatment strategies, the study hopes to find the best way to reduce the amount of the COVID-19 virus in a person's body. This could lead to better recovery and fewer health issues for people with weakened immune systems who get COVID-19. Participants in the study will have regular checks to measure the virus levels in their body.

Key takeaways

This study focuses on improving COVID-19 treatment for people with weakened immune systems.
It compares different lengths of Paxlovid treatment (5 vs. 10 days).
It also checks if combining Paxlovid with Veklury is more effective.
The main goal is to reduce the amount of virus in the body.
Participation helps future patients with similar health conditions.

Who may be eligible?

To join this study, you would need to meet certain conditions. Firstly, you must have been diagnosed with COVID-19, either by a PCR test or a rapid antigen test. Your COVID-19 symptoms should be mild or you might have no symptoms at all.

Crucially, you must also have a weakened immune system. This could be due to various reasons, such as having certain long-term health conditions, having had an organ or stem cell transplant, or taking medicines that suppress your immune system (like steroids for a long time, or specific treatments for cancer or autoimmune diseases). You need to be at least 16 years old to take part, or 18 if you are in Italy or Norway.

It's important that you don't have any health conditions that would prevent you from safely taking any of the study medicines. You also need to be willing and able to follow all the study instructions and attend any required appointments.

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.

Do I have a confirmed COVID-19 infection (mild or no symptoms)?
Do I have a weakened immune system due to an illness or medication?
Am I at least 16 years old (or 18 in certain countries)?
Am I able to take the study medicines and attend appointments?
Do I have full understanding of the study and willing to follow its rules?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be randomly assigned to one of several treatment groups. This is like flipping a coin to decide which treatment you get, ensuring fairness. You would receive either Paxlovid for 5 days, Paxlovid for 10 days, or a combination of Paxlovid and Veklury. All medicines will be provided as part of the study.

The study involves regular checks to see how well the treatment is working, particularly by measuring the amount of virus in your body. This will likely involve taking nose and throat swabs, especially around 10 days after starting treatment. You will also have follow-up appointments and checks to monitor your health and any side effects from the medicines. The total duration of your involvement in the study will depend on the specific treatment plan and follow-up schedule, but it is focused on the initial treatment and immediate effects.

Potential risks and benefits

Potential benefits of joining this study include receiving new or extended treatments for COVID-19 that might be more effective for people with weakened immune systems. You would also be closely monitored by medical professionals, and your participation helps researchers learn more about the best ways to treat COVID-19, which could help many others in the future. However, there's no guarantee that the treatment you receive will be better than standard care, and there's a possibility you might experience side effects from the medicines, as with any medication. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

Saint-André Hospital
Verified postcode
Bordeaux, France· Recruiting
Pellegrin Hospital
Verified postcode
Bordeaux, France· Recruiting
Francois Mitterrand Hospital
Verified postcode
Dijon, France· Recruiting
Croix Rousse Hospital
Verified postcode
Lyon, France· Recruiting
La Colombière Hospital
Verified postcode
Montpellier, France· Recruiting
Hotel Dieu Hospital
Verified postcode
Nantes, France· Recruiting
Laribosière Hospital
Verified postcode
Paris, France· Recruiting
Saint Antoine Hospital
Verified postcode
Paris, France· Recruiting
Pitié-Salpêtrière Hospital
Verified postcode
Paris, France· Recruiting
Saint Louis Hospital
Verified postcode
Paris, France· Recruiting
Bichat Claude-Bernard Hospital
Verified postcode
Paris, France· Recruiting
Robert Debré Hospital
Verified postcode
Reims, France· Recruiting

Common questions

What does 'immunocompromised' mean?

It means your body's immune system, which fights off infections, isn't working as strongly as usual. This can be due to illnesses, medicines, or certain medical treatments.

What is Paxlovid and Veklury?

Paxlovid and Veklury (also known as remdesivir) are both antiviral medicines specifically designed to help your body fight the COVID-19 virus.

Will I know which treatment I'm getting?

During the main part of the study, which treatment you get is chosen randomly, and sometimes neither you nor the doctors will know to keep the study fair. This helps to get the most accurate results.

How long will I be in the study if I participate?

The study focuses on the initial few weeks of treatment and recovery. You will have regular checks, especially during the first 10 days, and further follow-up appointments will be scheduled.

What if my COVID-19 gets worse during the study?

You will be closely monitored, and your study doctors will ensure you receive the appropriate medical care for your condition, regardless of your participation in the trial.

How to find out more

Douae Ammour

douae.ammour@inserm.fr +33782960531 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.