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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

September 6, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Post-Acute COVID-19 SyndromePost-Acute COVID-19Long 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.

Trial Locations (24)

10676

NOT_YET_RECRUITING

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

11527

RECRUITING

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

RECRUITING

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

RECRUITING

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

RECRUITING

Out-patient long-COVID department, Laiko General Hospital, Athens

12462

RECRUITING

2nd Department of Propedeutic Medicine, ATTIKON University General Hospital, Chaïdári

RECRUITING

4th Department of Internal Medicine, ATTIKON University General Hospital, Chaïdári

18536

RECRUITING

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

19600

RECRUITING

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

26504

RECRUITING

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

41110

NOT_YET_RECRUITING

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

54636

RECRUITING

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

68100

RECRUITING

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

Unknown

NOT_YET_RECRUITING

Out-patient long-COVID department, Jena University Hospital, Jena

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Department of Internal Medicine, Hospital of Jesolo, Italy, Jesolo

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Infectious Diseases Clinic, University of Modena, Italy, Modena

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

ID Respiratory Unit, Spallanzani Institute of Rome, Italy, Rome

NOT_YET_RECRUITING

Department of Pulmonary Medicine, Barcelona University Hospital, Barcelona

115 27

RECRUITING

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

455 00

RECRUITING

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

196 00

RECRUITING

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

All Listed Sponsors
lead

Hellenic Institute for the Study of Sepsis

OTHER