Post-Acute COVID-19 SyndromePhase 2/3PRECISIONNCT05926505
Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome
A Phase 2/3 study testing Anakinra 149 MG/ML Prefilled Syringe [Kineret] in people with Post-Acute COVID-19 Syndrome and Post-Acute COVID-19, run by Hellenic Institute for the Study of Sepsis at 24 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, Post-Acute COVID-19, Long COVID
- What is being tested?
- Anakinra 149 MG/ML Prefilled Syringe [Kineret]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 6 Sep 2023to Mar 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Show all 9Show fewer
- 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 score in HRCT more than 20 OR walking of a distance less than 500m in the 6-minute walk test
- If patients meet the criteria for both Conditions 1 and 2, they will be considered for randomization and evaluation for the primary endpoint as in Condition 1.
Who cannot join
- 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
Show all 16Show fewer
- 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 interventional trial
Trial locations and contacts
24 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 4 countries
Greece16 sites, 16 recruiting
- Recruiting
Out-patient long-COVID department, Alexandroupolis University General Hospital
Alexandroupoli, 68100
Periklis Panagopoulos, MD, PhD, 6944410495, ppanago@med.duth.gr
- Not yet recruiting
Out-patient long-COVID department III, Evangelismos Athens General Hospital
Athens, Attica, 10676
Paraskevi Katsaounou, MD, PhD, 6932668142, paraskevikatsaounou@gmail.com
- Recruiting
Out-patient long-COVID department I, Sotiria Athens Hospital of Chest Diseases
Athens, Attica, 11527
Garyphallia Poulakou, MD, PhD, 6945597583, gpoulakou@gmail.com
- Recruiting
Out-patient long-COVID department II, Sotiria Athens Hospital of Chest Diseases
Athens, Attica, 11527
Nikoletta Rovina, MD, PhD, 6945830212, nikrovina@med.uoa.gr
- Recruiting
Out-patient long-COVID department IV, Sotiria Athens Hospital of Chest Diseases
Athens, Attica, 11527
Ioannis Dimitroulis, MD, 6932666007, idimit@hotmail.com
- Recruiting
Out-patient long-COVID department, Laiko General Hospital
Athens, Attica, 11527
Michael Samarkos, MD, PhD, 6977470306, msamarkos@gmail.com
- Recruiting
Out-patient long-COVID department X, Sotiria Athens Hospital of Chest Diseases
Athens, 115 27
Ilias Kainis, DM, PhD, 6947528476, elikas60@gmail.com
- Recruiting
2nd Department of Propedeutic Medicine, ATTIKON University General Hospital
Chaïdári, Attica, 12462
Panagiotis Chalvatsiotis, MD, PhD, 6972275955, pahalv@gmail.com
- Recruiting
4th Department of Internal Medicine, ATTIKON University General Hospital
Chaïdári, Attica, 12462
Evangelos J. Giamarellos-Bourboulis, MD, PhD, 6945521800, egiamarel@med.uoa.gr
Christos Psarrakis, MD, 6980969012, chrispsarrakis@yahoo.com
- Recruiting
Out-patient long-COVID department, Ioannina University General Hospital
Ioannina, Ioannina, 455 00
Charalampos Milionis, MD, PhD, 6944521512, hmilioni@uoi.gr
- Not yet recruiting
Out-patient long-COVID department, University Hospital of Larissa
Larissa, 41110
George Dalekos, MD, PhD, 2413502285 / 6937759699, georgedalekos@gmail.com, skapeti1@gmail.com
- Recruiting
Out-patient long-COVID department II, Thriasio General Hospital of Elefsina
Magoula, 196 00
Konstantina Iliopoulou, MD, 6973391426, dr.iliopoulou@gmail.com
- Recruiting
Out-patient long-COVID department I, Thriasio General Hospital of Elefsina
Magoula, 19600
Styliani Sympardi, MD, 6971863078, lianasympa@hotmail.com
- Recruiting
Out-patient long-COVID department, Patras University General Hospital
Pátrai, Achaia, 26504
Argyrios Tzouvelekis, MD, PhD, 6944840010, atzouvelekis@upatras.gr, argyris.tzouvelekis@gmail.com
Vassiliki Georgiopoulou, MD, 6956469542, vickigeorgiopoulou@gmail.com
- Recruiting
Out-patient long-COVID department, Tzaneion Piraeus General Hospital
Piraeus, Piraeus, 18536
Styliani Gerakari, MD, 6973308684, sgerakari76@gmail.com
- Recruiting
Out-patient long-COVID department, AHEPA Hospital of Thessaloniki
Thessaloniki, 54636
Symeon Metallidis, MD, PhD, 6944361931, metallidissimeon@yahoo.gr
Italy6 sites, 6 recruiting
- Not yet recruiting
Infectious Diseases Clinic, Ospedale Policlinico San Martino IRCCS and Department of Health Sciences, University of Genova, Genoa, Italy
Genova
M. Bassetti, MD, PhD
- Not yet recruiting
Department of Internal Medicine, Hospital of Jesolo, Italy
Jesolo
Francesco Saverio-Serino, MD
- Not yet recruiting
Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele & Vita-Salute San Raffaele University, Milan, Italy
Milan
L. Dagna
- Not yet recruiting
Infectious Diseases Clinic, University of Modena, Italy
Modena
Giovanni Guaraldi, MD, PhD
- Not yet recruiting
Dipartimento Scienze di Laboratorio e Infettivologiche - Fondazione Policlinico Gemelli IRCCS, Roma Italy
Rome
M. Fantoni
- Not yet recruiting
ID Respiratory Unit, Spallanzani Institute of Rome, Italy
Rome
Fabrizio Palmieri, MD
Germany1 site, 1 recruiting
- Not yet recruiting
Out-patient long-COVID department, Jena University Hospital
Jena
P. Reuken
Spain1 site, 1 recruiting
- Not yet recruiting
Department of Pulmonary Medicine, Barcelona University Hospital
Barcelona
A. Torres
About this study
Official title: 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
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"
Read the detailed description
People with COVID-19 might have sustained post-infection sequelae, known as Post-Acute Covid Syndrome (PACS). A recent consensus definition by an international panel of 265 patients, clinicians, researchers, and WHO staff suggests that post-COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset, with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, and cognitive dysfunction and generally have an impact on everyday functioning.
The role of immune dysregulation in PACS is indirectly supported from the findings of the SAVE-MORE randomized clinical trial, in which patients with moderate and severe COVID-19, were 1:2 randomized to treatment with placebo or anakinra once daily for 10 days. The primary endpoint was the distribution of the frequencies of patients in the 11 points of the WHO clinical progression scale (CPS) by day 28. Patients' follow-up until day 90 showed significant reduction of the incidence of PACS; this was 24.4% among placebo-treated patients and 15.7% among patients treated with anakinra.
After the end of the SAVE-MORE trial, the understanding of the immune activation of PACS and the development of tools for the evaluation of patients have become the main aims of the Hellenic Institute for the study of sepsis (HISS) group. More precisely, patients with medical history of COVID-19 pneumonia during three separate time periods and matched comparators for age, sex, comorbidities, and state of vaccination were followed up and evaluated for PACS. Main findings can be summarized as follows:
- For at least one year after acute COVID-19 there is considerable immune dysregulation involving both the innate and the adaptive responses.
- Patients with PACS may be classified into four main phenotype clusters: fatigue involving 70.8%, respiratory cluster involving 33.2%, systemic symptoms involving 17.7% and other symptoms involving 26.1%.
- The risk for progression into PACS was significantly lower among patients treated with anakinra in the acute stage (odds ratio 0.59, p: 0.017) showing a role of IL-1 for the progression into PACS.
- Patients with fatigue bring distinct immunotype compared to the respiratory cluster.
- IP-10 (interferon-gamma-induced protein-10) at levels more than 250 pg/ml has sensitivity 99.3%, specificity 90.9%, positive predictive value (PPV) 97.9% and negative predictive value (NPV) 97.6% for the diagnosis of the post acute COVID immune dysregulation.
PRECISION is a proof-of-concept, randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of anakinra in patients with PACS in improving the clinical and immunological state over 4 to 8 weeks as measured by a composite endpoint, namely, the "Score of PACS progression reversal".
- Being tested
- Placebo, Anakinra 149 MG/ML Prefilled Syringe [Kineret]
- Keywords
- COVID-19, Long COVID, Post-Acute COVID-19, Anakinra, PRECISION, NCT05926505
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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.
Anakinra 149 MG/ML Prefilled Syringe [Kineret]Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo is injected subcutaneously once daily for 4 weeks. Receives: Drug: Placebo |
| Anakinra | Experimental | Anakinra is injected subcutaneously as 100 mg once daily for 4 weeks. Receives: Drug: Anakinra 149 MG/ML Prefilled Syringe [Kineret] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of PACS progression reversal
A positive score is defined differently for patients enrolled in the study because of Condition 1 or Condition 2. For patients enrolled in Condition 1, a positive score comprises at least two of the following: 1. At least 20% improvement of restrictive lung disease from baseline 2.No need for hospitalization οr admission to the Emergency Department 3. No increase of the degree of lung fibrosis score in lung HRCT For patients enrolled in Condition 2, a positive score comprises at least two of the following: 1. At least 20% decrease of the total score in lung HRCT OR Improved exercise capacity in the 6min walk test. 2.No need for hospitalization οr admission to the Emergency Department. 3.No increase of the degree of lung fibrosis score in lung HRCT.
The proportion of patients achieving the above composite endpoint compared to placebo at week 4 will be the primary study endpoint.
Measured: Through study completion,an average of 2 years
Secondary outcomes (5)
The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo).
The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo).
Measured: Through study completion,an average of 2 years
Changes of concentration of cytokines produced by stimulated PBMCs at week 4 between the two arms of treatment.
Changes of concentration of cytokines produced by stimulated PBMCs at week 4 between the two arms of treatment.
Measured: Through study completion,an average of 2 years
Change of each component of the score for the primary outcome at week 4 between the two arms of treatment.
Change of each component of the score for the primary outcome at week 4 between the two arms of treatment. Post-acute COVID-19 syndrome (PACS) score. The higher the score, the worst the patients' outcome. PACS score ranges between 0-16.
Measured: Through study completion,an average of 2 years
At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment.
At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment.
Measured: Through study completion,an average of 2 years
At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment.
At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment
Measured: Through study completion,an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start6 Sep 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Institute for the Study of Sepsis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evangelos Giamarelos-Bourboulis, MD,PhD, Study chair, Hellenic Institute for the Study of Sepsis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926505
- Sponsor's protocol ID
- PRECISION
- Other IDs
- 2023-000102-25, 2023
- Acronym
- PRECISION
- Status last verified
- Jan 2026
- First submitted
- 28 Jun 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05926505
- Acronym / sponsor ID
- PRECISION / PRECISION
- Keywords
- COVID-19, Long COVID, Post-Acute COVID-19, Anakinra, PRECISION, NCT05926505
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hellenic Institute for the Study of SepsisUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Detailed description
People with COVID-19 might have sustained post-infection sequelae, known as Post-Acute Covid Syndrome (PACS). A recent consensus definition by an international panel of 265 patients, clinicians, researchers, and WHO staff suggests that post-COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset, with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, and cognitive dysfunction and generally have an impact on everyday functioning.
The role of immune dysregulation in PACS is indirectly supported from the findings of the SAVE-MORE randomized clinical trial, in which patients with moderate and severe COVID-19, were 1:2 randomized to treatment with placebo or anakinra once daily for 10 days. The primary endpoint was the distribution of the frequencies of patients in the 11 points of the WHO clinical progression scale (CPS) by day 28. Patients' follow-up until day 90 showed significant reduction of the incidence of PACS; this was 24.4% among placebo-treated patients and 15.7% among patients treated with anakinra.
After the end of the SAVE-MORE trial, the understanding of the immune activation of PACS and the development of tools for the evaluation of patients have become the main aims of the Hellenic Institute for the study of sepsis (HISS) group. More precisely, patients with medical history of COVID-19 pneumonia during three separate time periods and matched comparators for age, sex, comorbidities, and state of vaccination were followed up and evaluated for PACS. Main findings can be summarized as follows:
- For at least one year after acute COVID-19 there is considerable immune dysregulation involving both the innate and the adaptive responses.
- Patients with PACS may be classified into four main phenotype clusters: fatigue involving 70.8%, respiratory cluster involving 33.2%, systemic symptoms involving 17.7% and other symptoms involving 26.1%.
- The risk for progression into PACS was significantly lower among patients treated with anakinra in the acute stage (odds ratio 0.59, p: 0.017) showing a role of IL-1 for the progression into PACS.
- Patients with fatigue bring distinct immunotype compared to the respiratory cluster.
- IP-10 (interferon-gamma-induced protein-10) at levels more than 250 pg/ml has sensitivity 99.3%, specificity 90.9%, positive predictive value (PPV) 97.9% and negative predictive value (NPV) 97.6% for the diagnosis of the post acute COVID immune dysregulation.
PRECISION is a proof-of-concept, randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of anakinra in patients with PACS in improving the clinical and immunological state over 4 to 8 weeks as measured by a composite endpoint, namely, the "Score of PACS progression reversal".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is injected subcutaneously once daily for 4 weeks. |
| Anakinra | Experimental | Drug: Anakinra 149 MG/ML Prefilled Syringe [Kineret]Anakinra is injected subcutaneously as 100 mg once daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- History of confirmed COVID-19 infection the last 90 days or more
Key exclusion criteria (16 listed)
- Age below 18 years
- Denial for written informed consent
- Any stage IV malignancy
- Any primary immunodeficiency
- Less than 1,500 neutrophils/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo 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 | Placebo |
| 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. | Drug | Anakinra |
Primary outcome
Score of PACS progression reversal
Time frame: Through study completion,an average of 2 years
A positive score is defined differently for patients enrolled in the study because of Condition 1 or Condition 2. For patients enrolled in Condition 1, a positive score comprises at least two of the following: 1. At least 20% improvement of restrictive lung disease from baseline 2.No need for hospitalization οr admission to the Emergency Department 3. No increase of the degree of lung fibrosis score in lung HRCT For patients enrolled in Condition 2, a positive score comprises at least two of the following: 1. At least 20% decrease of the total score in lung HRCT OR Improved exercise capacity in the 6min walk test. 2.No need for hospitalization οr admission to the Emergency Department. 3.No increase of the degree of lung fibrosis score in lung HRCT. The proportion of patients achieving the above composite endpoint compared to placebo at week 4 will be the primary study endpoint.
5 secondary outcomes
The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo).
Time frame: Through study completion,an average of 2 years
Changes of concentration of cytokines produced by stimulated PBMCs at week 4 between the two arms of treatment.
Time frame: Through study completion,an average of 2 years
Change of each component of the score for the primary outcome at week 4 between the two arms of treatment.
Time frame: Through study completion,an average of 2 years
At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment.
Time frame: Through study completion,an average of 2 years
At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment.
Time frame: Through study completion,an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evangelos Giamarelos-Bourboulis, MD,PhD study chair
Hellenic Institute for the Study of Sepsis
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anakinra 149 MG/ML Prefilled Syringe [Kineret] in people with Post-Acute COVID-19 Syndrome and Post-Acute COVID-19, run by Hellenic Institute for the Study of Sepsis at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Greece, Italy, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evangelos Giamarelos-Bourboulis, MD,PhD (00302105831994, egiamarel@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of PACS progression reversal (time frame: Through study completion,an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.