MedTrace Logo

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

NCT05926505 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-01-08

No results posted yet for this study

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"

Conditions

  • Post-Acute COVID-19 Syndrome
  • Post-Acute COVID-19
  • Long COVID

Interventions

DRUG

Placebo

Placebo is injected subcutaneously once daily for 4 weeks. After the period of 4 weeks, patients allocated to arm 1 will be shifted to subcutaneous treatment with 100mg anakinra once daily for 4 weeks.

DRUG

Anakinra 149 MG/ML Prefilled Syringe [Kineret]

Anakinra is injected subcutaneously as 100 mg once daily for 4 weeks. After the first period the patients will be randomized 1:1 to continue receiving subcutaneous treatment with 100mg anakinra once daily for 4 weeks or placebo once daily for 4 weeks.

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Evangelos Giamarelos-Bourboulis, MD,PhD · Hellenic Institute for the Study of Sepsis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Germany
  • Greece
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926505 on ClinicalTrials.gov