Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Age equal to or above 18 years
- Male or female gender
- 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.
- 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.
- History of confirmed COVID-19 infection the last 90 days or more
- 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
- Serum levels of IP-10 more than 250 pg/ml
- 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.
You will not qualify if you...
- Age below 18 years
- Denial for written informed consent
- Any stage IV malignancy
- Any primary immunodeficiency
- Less than 1,500 neutrophils/mm3
- Known hypersensitivity to anakinra
- Known lung fibrosis prior to COVID-19
- Medical history of pulmonary hypertension or chronic heart failure
- Known chronic obstructive pulmonary disease GOLD stage 3 or 4 prior to COVID-19
- Known active tuberculosis (under treatment) or latent tuberculosis (by positive tuberculin test)
- 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.
- Any anti-cytokine biological treatment the last one month
- Severe hepatic failure defined as Child-Pugh stage of 3
- End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis
- Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
- Participation in any other interventional trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here