Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05926505

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

Led by Hellenic Institute for the Study of Sepsis · Updated on 2026-01-08

182

Participants Needed

24

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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"

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.

Not Eligible

You will not qualify if you...

  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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

Out-patient long-COVID department, Jena University Hospital

Jena, Germany

Not Yet Recruiting

2

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

Pátrai, Achaia, Greece, 26504

Actively Recruiting

3

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

Athens, Attica, Greece, 10676

Not Yet Recruiting

4

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

Athens, Attica, Greece, 11527

Actively Recruiting

5

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

Athens, Attica, Greece, 11527

Actively Recruiting

6

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

Athens, Attica, Greece, 11527

Actively Recruiting

7

Out-patient long-COVID department, Laiko General Hospital

Athens, Attica, Greece, 11527

Actively Recruiting

8

2nd Department of Propedeutic Medicine, ATTIKON University General Hospital

Chaïdári, Attica, Greece, 12462

Actively Recruiting

9

4th Department of Internal Medicine, ATTIKON University General Hospital

Chaïdári, Attica, Greece, 12462

Actively Recruiting

10

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

Ioannina, Ioannina, Greece, 455 00

Actively Recruiting

11

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

Piraeus, Piraeus, Greece, 18536

Actively Recruiting

12

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

Alexandroupoli, Greece, 68100

Actively Recruiting

13

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

Athens, Greece, 115 27

Actively Recruiting

14

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

Larissa, Greece, 41110

Not Yet Recruiting

15

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

Magoula, Greece, 196 00

Actively Recruiting

16

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

Magoula, Greece, 19600

Actively Recruiting

17

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

Thessaloniki, Greece, 54636

Actively Recruiting

18

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

Genova, Italy

Not Yet Recruiting

19

Department of Internal Medicine, Hospital of Jesolo, Italy

Jesolo, Italy

Not Yet Recruiting

20

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

21

Infectious Diseases Clinic, University of Modena, Italy

Modena, Italy

Not Yet Recruiting

22

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

Rome, Italy

Not Yet Recruiting

23

ID Respiratory Unit, Spallanzani Institute of Rome, Italy

Rome, Italy

Not Yet Recruiting

24

Department of Pulmonary Medicine, Barcelona University Hospital

Barcelona, Spain

Not Yet Recruiting

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Research Team

E

Evangelos Giamarelos-Bourboulis, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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