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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

10 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

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).

What is already known about the treatment

Anakinra – Anakinra is administered through subcutaneous injection, meaning it is injected under the skin. It is currently being studied in clinical trials for its potential to treat Post-Acute COVID Syndrome (PACS), a condition with lingering symptoms following COVID-19 infection. The main therapeutic indication for anakinra in this context is to alleviate persistent respiratory symptoms and modulate immune system activation. At the molecular level, anakinra works by blocking the activity of interleukin-1, a protein involved in inflammatory responses, thereby reducing inflammation. It is classified pharmacologically as an interleukin-1 receptor antagonist.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508123-12-00Protocol codePRECISIONEstimated enrolment302 patientsSponsorHellenic Institute For The Study Of Sepsis

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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