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

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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"

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis
• Treatments: Interleukin 1 Receptor Antagonist Protein

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