Evaluating Safety and Effectiveness of Anakinra Treatment for Adults With Long-Term Respiratory Symptoms and Immune Activation After COVID-19

What this Trial Is About

Researchers are evaluating the efficacy and safety of anakinra in patients with Post-Acute COVID Syndrome PACS who have a pro-inflammatory respiratory phenotype. PACS affects individuals with a history of confirmed or probable COVID-19 infection, usually starting three months after infection and lasting at least two months with symptoms like fatigue, shortness of breath, and cognitive dysfunction. The study aims to improve understanding and treatment of PACS by measuring a combined outcome called the Score of PACS progression reversal. The trial is a randomized, double-blind study comparing anakinra to placebo. Participants receive subcutaneous injections once daily for four weeks one group gets anakinra 100 mg, while the other receives placebo. After the first four weeks, patients initially on placebo will switch to anakinra for another four weeks, and those on anakinra will be randomized to continue anakinra or switch to placebo for the next four weeks. This design allows assessment of treatment duration and effects over 4 to 8 weeks. Participants will undergo evaluations including lung function tests, radiology scores, and a 6-minute walk test. Blood samples will be analyzed for immune markers such as cytokine concentrations. Researchers will monitor the safety and clinical progress of participants over an average of two years, focusing on the primary outcome of PACS progression reversal. The study includes regular assessments to understand treatment impact and immune system changes related to PACS.

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