Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial (SolidAct)

This large study, called SolidAct, is designed to find out if a medicine called Baricitinib can help people who are in hospital with COVID-19. Researchers want to know if it can prevent patients from becoming more seriously ill, or even dying, compared to a placebo (a dummy pill with no active medicine). The study is in its final stages of testing, meaning it's evaluating the treatment's effectiveness and safety in many people. It's looking at patients with moderate to severe COVID-19 to see if this treatment can improve their recovery and reduce serious outcomes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Oslo University Hospital Hf

Enrolment target

2,000

Start

27 Apr 2022

SARS-CoV II infection (Coronavirus disease)

What is this study about?

This study, officially known as SolidAct, is a very important research project looking into potential treatments for COVID-19. It's like a big experiment designed to find out if a specific medicine, called Baricitinib (brand name Olumiant), can help people who are in hospital because of coronavirus. The study is split into different groups of patients, depending on how unwell they are when they join.

The main goal is to see if Baricitinib can stop people with COVID-19 from getting worse or, sadly, dying. For some patients, the study will check if their condition gets worse over 14 days, from being moderately ill to very ill or passing away. For others who are already quite unwell, the study will mainly look at whether the medicine can reduce the risk of death within 60 days. To make sure the results are fair, some patients will receive Baricitinib, while others will get a placebo, which looks identical but contains no active medicine. This allows researchers to compare the two groups and confidently say if the medicine is truly making a difference.

Besides these main goals, the study will also look at many other things to understand the treatment better. This includes how quickly people recover and are able to go home, if they need less oxygen, and how their bodies react to the virus and the medicine. They'll also monitor for any side effects and check how patients feel about their quality of life after 3 months. All this information helps doctors understand if Baricitinib is a safe and effective option for people with COVID-19.

Key takeaways

This study is for adults admitted to hospital with COVID-19.
It tests if Baricitinib, a specific medicine, can prevent severe illness or death.
Some patients will receive the medicine, others a dummy pill (placebo).
Participation involves taking tablets and having regular health checks.
The study helps find better treatments for COVID-19.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would generally need to be an adult, 18 years old or older. The study is open to both men and women.

The most important thing is that you have a confirmed SARS-CoV-2 infection, meaning you have COVID-19, and you are currently in hospital because of it. The study is particularly looking at people who are moderately or severely ill with COVID-19.

There might be other specific health conditions or medications that would mean you couldn't join, as these studies need to be safe for everyone involved. Your doctor would check all these details carefully to see if this study is right for you.

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?
Do you have a confirmed COVID-19 infection?
Are you currently admitted to hospital because of COVID-19?
Are you considered moderately or severely ill with COVID-19 by your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the study medicine, Baricitinib tablets, or a matching placebo (a dummy pill) to take. You'll take these film-coated tablets as prescribed by the study team. Throughout your time in the study, you'll have regular check-ups, which could include having blood tests, swabs to check for the virus, and other assessments to monitor your health and how you're responding to treatment.

The study will closely follow your health during your hospital stay and for a period after. This follow-up will involve checking for any changes in your condition, how quickly you recover, and if you have any side effects. You'll be monitored for at least 14 days for moderate illness, and up to 60 or 90 days in total for some assessments, including follow-up on your recovery and general well-being. The study team will explain everything in detail, including how long you'll be involved and what each assessment means.

Potential risks and benefits

There are different things to consider when joining a study like this. A potential benefit is that if the study medicine, Baricitinib, works, it could help you recover faster, prevent you from getting sicker, or even save your life compared to standard care. However, Baricitinib, like any medicine, can have side effects, and some people might experience unwanted reactions. Also, because some people receive a placebo, there's a chance you might not receive the active study medicine. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Norway
—
Unverified
Portugal
—
Unverified
France
—
Unverified
Greece
—
Unverified
Luxembourg
—
Unverified
Hungary
—
Unverified
Slovakia
—
Unverified
Italy
—
Unverified
Czechia
—
Unverified
Ireland
—
Unverified
Austria
—
Unverified
Spain

Common questions

What is Baricitinib?

Baricitinib is a medicine that works by calming down parts of your immune system that can become overactive during a COVID-19 infection.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.

Why is this study important?

This study is important because it could help doctors find new and effective ways to treat people who are seriously ill with COVID-19, potentially saving lives.

How long would I be in the study?

While the main treatment period is during your hospital stay, the study will continue to check on your health and recovery for up to 60-90 days, depending on the specific assessments.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point without needing a reason. This won't affect your medical care in any way.