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Anakinra in Post-Acute COVID Syndrome (PRECISION)
NCT05926505Phase 3
Key facts
- Status
- Recruiting
- Start
- Sep 2023
- Primary completion
- Mar 2028
- Countries
- 4
- Sponsor
- Hellenic Institute for the Study of Sepsis
- Modality
- Cytokines & Interferons
- Drugs
- anakinra
- Conditions
- post acute COVID-19 syndrome
01
Overview
Phase 3, randomised, double-blind trial of anakinra in post acute COVID-19 syndrome (2 arms), sponsored by Hellenic Institute for the Study of Sepsis. Primary endpoint: Score of PACS progression reversal at 2 years. Started Sep 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo -> Anakinra
Placebo for 4 weeks, then Anakinra 100mg for 4 weeks
Anakinra -> Anakinra/Placebo
Anakinra 100mg for 4 weeks, then randomized 1:1 to Anakinra 100mg or Placebo for 4 weeks
03
Who it enrols
Adults with Post-Acute COVID Syndrome (PACS) >90 days post-infection, symptoms >2 months, IP-10 >250 pg/ml, and impaired lung function or abnormal HRCT/6MWT. Excludes stage IV malignancy, primary immunodeficiency, severe hepatic/renal failure, and recent anti-cytokine or high-dose corticosteroid use.
04
Endpoints
Primary
Score of PACS progression reversal
Secondary
Frequency of the Score of PACS progression reversal
Changes of concentration of cytokines produced by stimulated PBMCs
Change of each component of the score for the primary outcome
At least 10% decrease of the pulmonary artery pressure
At least 10% increase of LV ejection fraction
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