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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome

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

Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome (NCT05926505) is a Phase 2 / Phase 3 interventional studying Post-Acute COVID-19 Syndrome and Post-Acute COVID-19, sponsored by Hellenic Institute for the Study of Sepsis. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The PRECISION is a proof-of-concept, phase II randomized clinical trial aiming to evaluate the efficacy and safety of anakinra in patients with Post-Acute COVID Syndrome (PACS) of the pro-inflammatory respiratory phenotype. Improvement is measured by a composite endpoint, namely, the "Score of PACS progression reversal"

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Post-Acute COVID-19 Syndrome and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 182 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Post-Acute COVID-19 Syndrome subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form provided by the patient. For subjects without decision-making capacity, willing to sign a consent form 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. Who Should NOT Join This Trial: 1. Age below 18 years 2. Denial for written willing to sign a consent form 3. Any stage IV malignancy 4. Any primary weakened immune system 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Placebo

Placebo is injected subcutaneously once daily for 4 weeks. After the period of 4 weeks, patients allocated to arm 1 will be shifted to subcutaneous treatment with 100mg anakinra once daily for 4 weeks.

DRUG

Anakinra 149 MG/ML Prefilled Syringe [Kineret]

Anakinra is injected subcutaneously as 100 mg once daily for 4 weeks. After the first period the patients will be randomized 1:1 to continue receiving subcutaneous treatment with 100mg anakinra once daily for 4 weeks or placebo once daily for 4 weeks.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Out-patient long-COVID department, Jena University Hospital
Jena, Germany
Out-patient long-COVID department, Patras University General Hospital
Pátrai, Achaia, Greece
Out-patient long-COVID department III, Evangelismos Athens General Hospital
Athens, Attica, Greece
Out-patient long-COVID department I, Sotiria Athens Hospital of Chest Diseases
Athens, Attica, Greece
Out-patient long-COVID department II, Sotiria Athens Hospital of Chest Diseases
Athens, Attica, Greece
Out-patient long-COVID department IV, Sotiria Athens Hospital of Chest Diseases
Athens, Attica, Greece
Out-patient long-COVID department, Laiko General Hospital
Athens, Attica, Greece
2nd Department of Propedeutic Medicine, ATTIKON University General Hospital
Chaïdári, Attica, Greece
4th Department of Internal Medicine, ATTIKON University General Hospital
Chaïdári, Attica, Greece
Out-patient long-COVID department, Ioannina University General Hospital
Ioannina, Ioannina, Greece
Out-patient long-COVID department, Tzaneion Piraeus General Hospital
Piraeus, Piraeus, Greece
Out-patient long-COVID department, Alexandroupolis University General Hospital
Alexandroupoli, Greece
Out-patient long-COVID department X, Sotiria Athens Hospital of Chest Diseases
Athens, Greece
Out-patient long-COVID department, University Hospital of Larissa
Larissa, Greece
Out-patient long-COVID department II, Thriasio General Hospital of Elefsina
Magoula, Greece
Out-patient long-COVID department I, Thriasio General Hospital of Elefsina
Magoula, Greece
Out-patient long-COVID department, AHEPA Hospital of Thessaloniki
Thessaloniki, Greece
Infectious Diseases Clinic, Ospedale Policlinico San Martino IRCCS and Department of Health Sciences, University of Genova, Genoa, Italy
Genova, Italy
Department of Internal Medicine, Hospital of Jesolo, Italy
Jesolo, Italy
Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele & Vita-Salute San Raffaele University, Milan, Italy
Milan, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05926505), the sponsor (Hellenic Institute for the Study of Sepsis), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05926505 clinical trial studying?

The PRECISION is a proof-of-concept, phase II randomized clinical trial aiming to evaluate the efficacy and safety of anakinra in patients with Post-Acute COVID Syndrome (PACS) of the pro-inflammatory respiratory phenotype. Improvement is measured by a composite endpoint, namely, the "Score of PACS progression reversal" The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05926505?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05926505?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05926505. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05926505. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.