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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Post-Acute COVID-19 Syndrome, Post-Acute COVID-19, Long COVID

In brief

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"

Key facts

Study ID: NCT05926505
Run by: Hellenic Institute for the Study of Sepsis
People needed: 182
Starts: 2023-09-06
Expected to finish: 2028-03-01
Last updated by the study team: 2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 may not qualify if…

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

Where it is running

Out-patient long-COVID department II, Thriasio General Hospital of Elefsina — Magoula, Greece (enrolling)
Out-patient long-COVID department I, Thriasio General Hospital of Elefsina — Magoula, Greece (enrolling)
Out-patient long-COVID department, AHEPA Hospital of Thessaloniki — Thessaloniki, Greece (enrolling)
Out-patient long-COVID department I, Sotiria Athens Hospital of Chest Diseases — Athens, Attica, Greece (enrolling)
Out-patient long-COVID department II, Sotiria Athens Hospital of Chest Diseases — Athens, Attica, Greece (enrolling)
Out-patient long-COVID department IV, Sotiria Athens Hospital of Chest Diseases — Athens, Attica, Greece (enrolling)
Out-patient long-COVID department, Laiko General Hospital — Athens, Attica, Greece (enrolling)
2nd Department of Propedeutic Medicine, ATTIKON University General Hospital — Chaïdári, Attica, Greece (enrolling)
4th Department of Internal Medicine, ATTIKON University General Hospital — Chaïdári, Attica, Greece (enrolling)
Out-patient long-COVID department, Ioannina University General Hospital — Ioannina, Ioannina, Greece (enrolling)
Out-patient long-COVID department, Tzaneion Piraeus General Hospital — Piraeus, Piraeus, Greece (enrolling)
Out-patient long-COVID department, Alexandroupolis University General Hospital — Alexandroupoli, Greece (enrolling)
Out-patient long-COVID department X, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (enrolling)
Out-patient long-COVID department, Patras University General Hospital — Pátrai, Achaia, Greece (enrolling)
Department of Pulmonary Medicine, Barcelona University Hospital — Barcelona, Spain
Out-patient long-COVID department III, Evangelismos Athens General Hospital — Athens, Attica, Greece
Out-patient long-COVID department, University Hospital of Larissa — Larissa, 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
Infectious Diseases Clinic, University of Modena, Italy — Modena, Italy
Dipartimento Scienze di Laboratorio e Infettivologiche - Fondazione Policlinico Gemelli IRCCS, Roma Italy — Rome, Italy
ID Respiratory Unit, Spallanzani Institute of Rome, Italy — Rome, Italy
Out-patient long-COVID department, Jena University Hospital — Jena, Germany

Full record on ClinicalTrials.gov

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