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Can a drug calm long COVID's lung inflammation? new trial aims to find out

NCT ID NCT05926505

Disease control Sponsor: Hellenic Institute for the Study of Sepsis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if the drug anakinra can help people with long COVID who have ongoing breathing issues and signs of an overactive immune system. About 182 adults will receive either anakinra or a placebo for up to 8 weeks. The goal is to see if the drug improves lung function, reduces lung scarring, and prevents hospital visits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

COVID-19 long COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Long COVID Post-acute COVID-19 Post-acute COVID-19 syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 2nd Department of Propedeutic Medicine, ATTIKON University General Hospital

    RECRUITING

    Chaïdári, Attica, 12462, Greece

  • 4th Department of Internal Medicine, ATTIKON University General Hospital

    RECRUITING

    Chaïdári, Attica, 12462, Greece

  • Department of Internal Medicine, Hospital of Jesolo, Italy

    NOT_YET_RECRUITING

    Jesolo, Italy

  • Department of Pulmonary Medicine, Barcelona University Hospital

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Dipartimento Scienze di Laboratorio e Infettivologiche - Fondazione Policlinico Gemelli IRCCS, Roma Italy

    NOT_YET_RECRUITING

    Rome, Italy

  • ID Respiratory Unit, Spallanzani Institute of Rome, Italy

    NOT_YET_RECRUITING

    Rome, Italy

  • Infectious Diseases Clinic, Ospedale Policlinico San Martino IRCCS and Department of Health Sciences, University of Genova, Genoa, Italy

    NOT_YET_RECRUITING

    Genova, Italy

  • Infectious Diseases Clinic, University of Modena, Italy

    NOT_YET_RECRUITING

    Modena, Italy

  • Out-patient long-COVID department I, Sotiria Athens Hospital of Chest Diseases

    RECRUITING

    Athens, Attica, 11527, Greece

  • Out-patient long-COVID department I, Thriasio General Hospital of Elefsina

    RECRUITING

    Magoula, 19600, Greece

  • Out-patient long-COVID department II, Sotiria Athens Hospital of Chest Diseases

    RECRUITING

    Athens, Attica, 11527, Greece

  • Out-patient long-COVID department II, Thriasio General Hospital of Elefsina

    RECRUITING

    Magoula, 196 00, Greece

  • Out-patient long-COVID department III, Evangelismos Athens General Hospital

    NOT_YET_RECRUITING

    Athens, Attica, 10676, Greece

  • Out-patient long-COVID department IV, Sotiria Athens Hospital of Chest Diseases

    RECRUITING

    Athens, Attica, 11527, Greece

  • Out-patient long-COVID department X, Sotiria Athens Hospital of Chest Diseases

    RECRUITING

    Athens, 115 27, Greece

  • Out-patient long-COVID department, AHEPA Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, 54636, Greece

  • Out-patient long-COVID department, Alexandroupolis University General Hospital

    RECRUITING

    Alexandroupoli, 68100, Greece

  • Out-patient long-COVID department, Ioannina University General Hospital

    RECRUITING

    Ioannina, Ioannina, 455 00, Greece

  • Out-patient long-COVID department, Jena University Hospital

    NOT_YET_RECRUITING

    Jena, Germany

  • Out-patient long-COVID department, Laiko General Hospital

    RECRUITING

    Athens, Attica, 11527, Greece

  • Out-patient long-COVID department, Patras University General Hospital

    RECRUITING

    Pátrai, Achaia, 26504, Greece

  • Out-patient long-COVID department, Tzaneion Piraeus General Hospital

    RECRUITING

    Piraeus, Piraeus, 18536, Greece

  • Out-patient long-COVID department, University Hospital of Larissa

    NOT_YET_RECRUITING

    Larissa, 41110, Greece

  • Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele & Vita-Salute San Raffaele University, Milan, Italy

    NOT_YET_RECRUITING

    Milan, Italy

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Other studies related to the condition(s) this trial covers.