Testing Anakinra for Lingering Breathing Symptoms After COVID-19

Trial details

Who runs it

Hellenic Institute for the Study of Sepsis

Trial code

NCT05926505EU 2023-508123-12-00

Record updated

8 January 2026

Original description

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"Read full original descriptionShow less

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

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"

Inclusion: 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.

Exclusion: Known lung fibrosis prior to COVID-19; Known chronic obstructive pulmonary disease GOLD stage 3 or 4 prior to COVID-19; 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 stage IV malignancy; Known hypersensitivity to anakinra; Medical history of pulmonary hypertension or chronic heart failure; Known active tuberculosis (under treatment) or latent tuberculosis (by positive tuberculin test); Severe hepatic failure defined as Child-Pugh stage of 3; End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis; Less than 1,500 neutrophils/mm3; Age below 18 years; Denial for written informed consent; Any primary immunodeficiency; Any anti-cytokine biological treatment the last one month; 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.

ClinicalTrials.gov NCT05926505 · EU CTIS 2023-508123-12-00