Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome
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
| Condition(s) | Post-Acute COVID-19 Syndrome, Post-Acute COVID-19, Long COVID |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | 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" |
| Who can participate | Inclusion Criteria: 1. Age equal to or above 18 years 2. Male or female gender 3. 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. 4. 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 n |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hellenic Institute for the Study of Sepsis |
| Locations | Jena, Germany; Pátrai, Achaia, Greece; Athens, Attica, Greece; Athens, Attica, Greece; Athens, Attica, Greece; Athens, Attica, Greece (+18 more sites) |
| Start date | 2023-09-06 |
| NCT ID | NCT05926505 |
| Official listing | https://clinicaltrials.gov/study/NCT05926505 |