NCT05926505 Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome
| NCT ID | NCT05926505 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Hellenic Institute for the Study of Sepsis |
| Condition | Post-Acute COVID-19 Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2023-09-06 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 182 participants in total. It began in 2023-09-06 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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"
Eligibility Criteria
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 national legislation in the Member State where the trial is planned. 5. History of confirmed COVID-19 infection the last 90 days or more 6. 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 7. Serum levels of IP-10 more than 250 pg/ml 8. 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. Exclusion Criteria: 1. Age below 18 years 2. Denial for written informed consent 3. Any stage IV malignancy 4. Any primary immunodeficiency 5. Less than 1,500 neutrophils/mm3 6. Known hypersensitivity to anakinra 7. Known lung fibrosis prior to COVID-19 8. Medical history of pulmonary hypertension or chronic heart failure 9. Known chronic obstructive pulmonary disease GOLD stage 3 or 4 prior to COVID-19 10. Known active tuberculosis (under treatment) or latent tuberculosis (by positive tuberculin test) 11. 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. 12. Any anti-cytokine biological treatment the last one month 13. Severe hepatic failure defined as Child-Pugh stage of 3 14. End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis 15. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study 16. Participation in any other interventional trial
Contact & Investigator
Evangelos Giamarelos-Bourboulis, MD,PhD
STUDY CHAIR
Hellenic Institute for the Study of Sepsis
Frequently Asked Questions
Who can join the NCT05926505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Acute COVID-19 Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05926505 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05926505 currently recruiting?
Yes, NCT05926505 is actively recruiting participants. Contact the research team at egiamarel@med.uoa.gr for enrollment information.
Where is the NCT05926505 trial being conducted?
This trial is being conducted at Jena, Germany, Pátrai, Greece, Athens, Greece, Athens, Greece and 11 additional locations.
Who is sponsoring the NCT05926505 clinical trial?
NCT05926505 is sponsored by Hellenic Institute for the Study of Sepsis. The principal investigator is Evangelos Giamarelos-Bourboulis, MD,PhD at Hellenic Institute for the Study of Sepsis. The trial plans to enroll 182 participants.
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