RecruitingPhase 2Phase 3NCT05926505

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

Safety and Efficacy of Anakinra Treatment for Patients With Persistent Respiratory Symptoms Post Acute Covid and Immune System Activation: the Precision Double-blind, Randomized Clinical Trial

Sponsor

Hellenic Institute for the Study of Sepsis

Enrollment

182 participants

Start Date

Sep 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anakinra 149 MG/ML Prefilled Syringe [Kineret] and a drug called Placebo for people with long covid, post-acute covid-19, and other related conditions. The study is currently recruiting participants at 24 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

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.

DRUGAnakinra 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.

Locations(24)

Out-patient long-COVID department, Jena University Hospital

Jena, Germany

Out-patient long-COVID department, Patras University General Hospital

Pátrai, Achaia, Greece

Out-patient long-COVID department III, Evangelismos Athens General Hospital

Athens, Attica, Greece

Out-patient long-COVID department I, Sotiria Athens Hospital of Chest Diseases

Athens, Attica, Greece

Out-patient long-COVID department II, Sotiria Athens Hospital of Chest Diseases

Athens, Attica, Greece

Out-patient long-COVID department IV, Sotiria Athens Hospital of Chest Diseases

Athens, Attica, Greece

Out-patient long-COVID department, Laiko General Hospital

Athens, Attica, Greece

2nd Department of Propedeutic Medicine, ATTIKON University General Hospital

Chaïdári, Attica, Greece

4th Department of Internal Medicine, ATTIKON University General Hospital

Chaïdári, Attica, Greece

Out-patient long-COVID department, Ioannina University General Hospital

Ioannina, Ioannina, Greece

Out-patient long-COVID department, Tzaneion Piraeus General Hospital

Piraeus, Piraeus, Greece

Out-patient long-COVID department, Alexandroupolis University General Hospital

Alexandroupoli, Greece

Out-patient long-COVID department X, Sotiria Athens Hospital of Chest Diseases

Athens, Greece

Out-patient long-COVID department, University Hospital of Larissa

Larissa, Greece

Out-patient long-COVID department II, Thriasio General Hospital of Elefsina

Magoula, Greece

Out-patient long-COVID department I, Thriasio General Hospital of Elefsina

Magoula, Greece

Out-patient long-COVID department, AHEPA Hospital of Thessaloniki

Thessaloniki, Greece

Infectious Diseases Clinic, Ospedale Policlinico San Martino IRCCS and Department of Health Sciences, University of Genova, Genoa, Italy

Genova, Italy

Department of Internal Medicine, Hospital of Jesolo, Italy

Jesolo, Italy

Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele & Vita-Salute San Raffaele University, Milan, Italy

Milan, Italy

Infectious Diseases Clinic, University of Modena, Italy

Modena, Italy

Dipartimento Scienze di Laboratorio e Infettivologiche - Fondazione Policlinico Gemelli IRCCS, Roma Italy

Rome, Italy

ID Respiratory Unit, Spallanzani Institute of Rome, Italy

Rome, Italy

Department of Pulmonary Medicine, Barcelona University Hospital

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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