Study on Anakinra for Patients with Long COVID and Ongoing Respiratory Symptoms

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What is this study about?

This clinical trial is focused on studying the effects of a medication called anakinra for individuals experiencing ongoing respiratory symptoms after recovering from COVID-19. This condition is often referred to as Post-Acute COVID Syndrome (PACS). The trial aims to assess whether anakinra can help improve both the physical and immune system health of these patients.

Participants in the study will receive anakinra, which is administered as a solution for injection. The study will compare the effects of taking anakinra for either four weeks or eight weeks. Some participants will receive a placebo for part of the study period. The goal is to determine if a longer duration of anakinra treatment leads to better outcomes in terms of reducing symptoms and improving lung function.

The trial will last between four to eight weeks, during which various health indicators will be monitored. These include changes in lung function, immune response, and overall physical performance, such as the distance walked in a six-minute walk test. The safety of anakinra will also be closely observed throughout the study.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, gender, and a history of COVID-19 infection.

Written informed consent is required to participate.

2 initial assessment

An initial assessment is conducted to evaluate lung function and radiological findings.

This includes tests like DLCOcor, TLC, and FVC, as well as a high-resolution chest tomography.

3 treatment phase

Participants are randomly assigned to receive either anakinra or a placebo.

Anakinra is administered as a 100 mg/0.67 ml solution for injection, either intravenously or subcutaneously.

The treatment duration is either 4 weeks or 8 weeks, depending on the group assignment.

4 monitoring and evaluation

Throughout the treatment, participants are monitored for changes in symptoms and overall health.

Evaluations include measuring the Score of PACS progression reversal and other health indicators such as cytokine production and pulmonary artery pressure.

5 follow-up

After completing the treatment phase, follow-up assessments are conducted to evaluate the long-term effects of the treatment.

These assessments may include a 6-minute walk test and other health evaluations.

Who Can Join the Study?

Must be 18 years or older.
Can be male or female.
If you are a woman who can have children or a man, you need to use a reliable method of birth control during the study.
Must provide written informed consent, which means you agree to participate after understanding the study details.
Must have had a confirmed COVID-19 infection at least 90 days ago or more.
Must have symptoms related to Post-Acute COVID Syndrome (PACS) that have lasted for more than 2 months. These symptoms should affect your daily activities.
Must have two specific conditions at the same time:
- Impaired Lung Function tests, which means certain lung tests show lower than normal results. These tests include:
  - DLCOcor: A test measuring how well your lungs transfer gas, should be less than 76%.
  - TLC: Total lung capacity, should be lower than normal.
  - FVC: Forced vital capacity, should be lower than normal.
- Radiological findings: A high-resolution chest scan shows patterns in the lungs that look like inflammation or a mix of inflammation and scarring, affecting at least 15% of the lungs.

Who Cannot Join the Study?

Patients who are currently pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medication are excluded.
Patients with significant liver or kidney disease are not eligible.
People with active infections that require treatment are excluded.
Individuals who have participated in another clinical trial within the last 30 days cannot join.
Patients with a history of certain heart conditions may not be eligible.
Individuals with uncontrolled high blood pressure are excluded.
Patients with a history of cancer within the last 5 years, except for certain skin cancers, are not eligible.
People with a history of drug or alcohol abuse within the past year are excluded.
Individuals who are unable to comply with the study procedures are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Medicine Greifswald	Greifswald	Germany

Other Sites

Site Name	City	Country
Evangelismos S.A.	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
General University Hospital Of Patras	Patras	Greece
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Geniko Nosokomeio Peiraia Tzaneio	Piraeus	Greece
National Institute For Infectious Diseases Lazzaro Spallanzani	Rome	Italy
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
General Hospital Of Eleusina Thriasio	Eleusina	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Lqwos Gjpjnlj Hwcyebkk Od Alknlj	Athens	Greece
Uispdxennl Gvimbut Hpefaiaj Ageglgc	Athens	Greece

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	19.06.2023
Greece	Recruiting	19.06.2023
Italy	Not yet recruiting	19.06.2023
Spain	Not yet recruiting	19.06.2023

Trial locations

Investigated drugs:

Anakinra

Anakinra is a medication being studied for its potential to help patients who have ongoing respiratory symptoms after recovering from acute COVID-19. This trial is investigating whether Anakinra can improve both the clinical symptoms and the immune system function of these patients over a period of 4 to 8 weeks. The goal is to see if Anakinra can reverse the progression of symptoms associated with post-acute COVID syndrome (PACS).

Investigated diseases:

Post-acute COVID-19 syndrome

Post-Acute COVID Syndrome (PACS) – This condition occurs in individuals who have recovered from the acute phase of COVID-19 but continue to experience symptoms. These symptoms can include fatigue, shortness of breath, and cognitive difficulties, often referred to as “brain fog.” The progression of PACS can vary widely among individuals, with some experiencing symptoms that persist for weeks or months. The exact cause of these prolonged symptoms is not fully understood, but it is believed to involve a combination of immune response, inflammation, and possibly organ damage from the initial infection. The condition can affect multiple systems in the body, leading to a wide range of symptoms that can impact daily life.

Trial ID:

2023-508123-12-00

Protocol code:

PRECISION

Trial Phase:

Therapeutic use (Phase IV)

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Study on Anakinra for Patients with Long COVID and Ongoing Respiratory Symptoms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?