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

Ki vehet részt

• 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

Ki nem vehet részt

• 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