Evaluating Anakinra for Long COVID Symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and efficacy of anakinra, an anti-inflammatory medication, in treating patients suffering from Post-Acute COVID Syndrome (PACS). The study will involve a randomized, controlled approach where participants will receive either anakinra or a placebo. Improvement will be measured using a composite endpoint that evaluates the reversal of PACS progression. The trial is designed to gather insights into the immune dysregulation associated with long COVID and its potential treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age equal to or above 18 years
2. Male or female gender
3. In the case of women of childbearing age and men, an adequate method of contraception should be used during the study. Contraception should be maintained for at least a period of 3 months after the discontinuation of treatment. As an adequate method of contraception, it is suggested: -male or female condom with or without spermicide -contraceptive cap, a diaphragm or contraceptive sponge with a spermicide Prior to admission to the study, a pregnancy test will be performed to exclude pregnancy to women of childbearing age.
4. Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation in the Member State where the trial is planned.
5. History of confirmed COVID-19 infection the last 90 days or more
6. Symptoms compatible with PACS (defined as at least one positive answer to the questionnaire for restriction of daily activities) lasting for more than 2 months
7. Serum levels of IP-10 more than 250 pg/ml
8. Presence of ONE of the following two clinical conditions: Condition 1: Impaired Lung Function tests (defined as: DLCOcor \<76% AND TLC and/or FVC lower than 80% of predicted) Condition 2: At least a total radiology score in HRCT more than 20 OR walking of a distance less than 500m in the 6-minute walk test

If patients meet the criteria for both Conditions 1 and 2, they will be considered for randomization and evaluation for the primary endpoint as in Condition 1.

Exclusion Criteria:

1. Age below 18 years
2. Denial for written informed consent
3. Any stage IV malignancy
4. Any primary immunodeficiency
5. Less than 1,500 neutrophils/mm3
6. Known hypersensitivity to anakinra
7. Known lung fibrosis prior to COVID-19
8. Medical history of pulmonary hypertension or chronic heart failure
9. Known chronic obstructive pulmonary disease GOLD stage 3 or 4 prior to COVID-19
10. Known active tuberculosis (under treatment) or latent tuberculosis (by positive tuberculin test)
11. Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days.
12. Any anti-cytokine biological treatment the last one month
13. Severe hepatic failure defined as Child-Pugh stage of 3
14. End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis
15. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
16. Participation in any other interventional trial

Where it's running

• Out-patient long-COVID department, Patras University General Hospital
  Pátrai, Achaia, Greece Recruiting
• Out-patient long-COVID department I, Sotiria Athens Hospital of Chest Diseases
  Athens, Attica, Greece Recruiting
• Out-patient long-COVID department II, Sotiria Athens Hospital of Chest Diseases
  Athens, Attica, Greece Recruiting
• Out-patient long-COVID department IV, Sotiria Athens Hospital of Chest Diseases
  Athens, Attica, Greece Recruiting
• Out-patient long-COVID department, Laiko General Hospital
  Athens, Attica, Greece Recruiting
• 2nd Department of Propedeutic Medicine, ATTIKON University General Hospital
  Chaïdári, Attica, Greece Recruiting

Study contacts

• Study coordinator: Evangelos Giamarelos-Bourboulis, MD,PhD
• Email: egiamarel@med.uoa.gr
• Phone: 00302105831994

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biomarker study to understand Long COVID using VIPER

  This study tests biomarkers in people with Long COVID and those who recovered from COVID-19 to see how they can diagnose and track the condition over time.

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• PERCEIVE-Outreach: A scalable care model to help people with Long COVID manage heart and lung symptoms

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.