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

Phase 1

Conditions: Post-Acute COVID Syndrome (PACS)
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-508123-12-00

Lead Sponsor: Hellenic Institute For The Study Of Sepsis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 182

Inclusion Criteria

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., Written informed consent provided by the patient., 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, Parallel presence of two conditions: a) impaired Lung Function tests (defined as: DLCOcor <76% or TLC lower than normal or FVC lower than normal) AND b) radiological findings in high resolution chest tomography compatible with inflammatory-like pattern or mixed inflammatory-fibrotic pattern involving at least 15% of the total lung parenchyma.

Exclusion Criteria

Age below 18 years, 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, 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