Evaluating Anakinra for Long COVID Symptoms

Safety and Efficacy of Anakinra Treatment for Patients With Persistent Respiratory Symptoms Post Acute Covid and Immune System Activation: the Precision Double-blind, Randomized Clinical Trial

This study is testing if anakinra, an anti-inflammatory medication, can help people with long COVID symptoms feel better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hellenic Institute for the Study of Sepsis (Academic / other)
• Drugs / interventions: prednisone
• Locations: 24 sites (Jena and 23 other locations)
• Trial ID: NCT05926505 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed history of COVID-19 and ongoing symptoms consistent with PACS.

Not a fit: Patients who have not experienced COVID-19 or those with alternative diagnoses explaining their symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate the debilitating symptoms of long COVID, improving patients' quality of life.

How similar studies have performed: Previous studies, such as the SAVE-MORE trial, have shown promising results in reducing PACS incidence with similar treatment approaches.

Eligibility criteria

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 this trial is running

Jena and 23 other locations

• Out-patient long-COVID department, Jena University Hospital — Jena, Germany (Not_yet_recruiting)
• Out-patient long-COVID department, Patras University General Hospital — Pátrai, Achaia, Greece (Recruiting)
• Out-patient long-COVID department III, Evangelismos Athens General Hospital — Athens, Attica, Greece (Not_yet_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)
• 4th Department of Internal Medicine, ATTIKON University General Hospital — Chaïdári, Attica, Greece (Recruiting)
• Out-patient long-COVID department, Ioannina University General Hospital — Ioannina, Ioannina, Greece (Recruiting)
• Out-patient long-COVID department, Tzaneion Piraeus General Hospital — Piraeus, Piraeus, Greece (Recruiting)
• Out-patient long-COVID department, Alexandroupolis University General Hospital — Alexandroupoli, Greece (Recruiting)
• Out-patient long-COVID department X, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (Recruiting)
• Out-patient long-COVID department, University Hospital of Larissa — Larissa, Greece (Not_yet_recruiting)
• Out-patient long-COVID department II, Thriasio General Hospital of Elefsina — Magoula, Greece (Recruiting)
• Out-patient long-COVID department I, Thriasio General Hospital of Elefsina — Magoula, Greece (Recruiting)
• Out-patient long-COVID department, AHEPA Hospital of Thessaloniki — Thessaloniki, Greece (Recruiting)
• Infectious Diseases Clinic, Ospedale Policlinico San Martino IRCCS and Department of Health Sciences, University of Genova, Genoa, Italy — Genova, Italy (Not_yet_recruiting)
• Department of Internal Medicine, Hospital of Jesolo, Italy — Jesolo, Italy (Not_yet_recruiting)
• Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele & Vita-Salute San Raffaele University, Milan, Italy — Milan, Italy (Not_yet_recruiting)
• Infectious Diseases Clinic, University of Modena, Italy — Modena, Italy (Not_yet_recruiting)
• Dipartimento Scienze di Laboratorio e Infettivologiche - Fondazione Policlinico Gemelli IRCCS, Roma Italy — Rome, Italy (Not_yet_recruiting)
• ID Respiratory Unit, Spallanzani Institute of Rome, Italy — Rome, Italy (Not_yet_recruiting)
• Department of Pulmonary Medicine, Barcelona University Hospital — Barcelona, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Evangelos Giamarelos-Bourboulis, MD,PhD

Conditions Post-Acute COVID-19 Syndrome; Post-Acute COVID-19; Long COVID; COVID-19; Anakinra; PRECISION; NCT05926505