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Tests treatment safety and results for Post-Acute COVID-19 Syndrome
Official title Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome
ClinicalTrials.gov ID: NCT05926505
What this study is testing
What is Anakinra 149 MG/ML Prefilled Syringe [Kineret]?
Anakinra 149 MG/ML Prefilled Syringe [Kineret] is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for post-acute covid-19 syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Written informed consent provided by the patient. For people without decision-making capacity, informed consent must be obtained from a legally...
- History of confirmed COVID-19 infection the last 90 days or more
You likely can't join if
- Age below 18 years
- Denial for written informed consent
- Any stage IV malignancy
- Any primary immunodeficiency
- Less than 1,500 neutrophils/mm3
- Known hypersensitivity to anakinra
See the full eligibility criteria
- 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...
- Written informed consent provided by the patient. For people without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation in the Member...
- History of confirmed COVID-19 infection the last 90 days or more
- 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
- Serum levels of IP-10 more than 250 pg/ml
- 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...
- Age below 18 years
- Denial for written informed consent
- Any stage IV malignancy
- Any primary immunodeficiency
- Less than 1,500 neutrophils/mm3
- Known hypersensitivity to anakinra
- Known lung fibrosis prior to COVID-19
- Medical history of pulmonary hypertension or chronic heart failure
- Known chronic obstructive pulmonary disease GOLD stage 3 or 4 prior to COVID-19
- Known active tuberculosis (under treatment) or latent tuberculosis (by positive tuberculin test)
- 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.
- Any anti-cytokine biological treatment the last one month
- Severe hepatic failure defined as Child-Pugh stage of 3
- End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis
- Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
- Participation in any other treatment trial
The study team makes the final eligibility decision.
Where it's taking place
- Jena, Germany
- Pátrai, Achaia, Greece
- Athens, Attica, Greece
- Chaïdári, Attica, Greece
- Ioannina, Ioannina, Greece
- Piraeus, Piraeus, Greece
- Alexandroupoli, Greece
- Athens, Greece
- Larissa, Greece
- Magoula, Greece
- Thessaloniki, Greece
- Genova, Italy
- Jesolo, Italy
- Milan, Italy
- Modena, Italy
- Rome, Italy
- Barcelona, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jena, Germany; Pátrai, Achaia, Greece; Athens, Attica, Greece; Chaïdári, Attica, Greece; Ioannina, Ioannina, Greece; Piraeus, Piraeus, Greece and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.