Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHellenic Institute for the Study of Sepsis
About this trial
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
Qualifiers
Age equal to or above 18 years
Male or female gender
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.
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.
Disqualifiers
Age below 18 years
Denial for written informed consent
Any stage IV malignancy
Any primary immunodeficiency
Trial design
Treatments tested in this trial
- Placebo
- Anakinra 149 MG/ML Prefilled Syringe [Kineret]
Treatment groups
182 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov