Διεθνείς μελέτες με συμμετοχή του ΕΚΠΑ

Συμμετοχή σε διεθνείς πολυκεντρικές μελέτες με ερευνήτρια ή συνερευνήτρια για το Παν. Γ.Ν.ΑΤΤΙΚΟΝ την Καθηγήτρια ΕΚΠΑ Αναστασία Αντωνιάδου.

1. Tίτλος μελέτης : An International Observational Study to Characterize Adults Who Are Hospitalized with Influenza or Other Targeted Respiratory Viruses. Short title of the study: FLU 003 Plus
   A Multicenter Study of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), Funded by the National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH)

Κύριος ερευνητής για το Παν. Γ.Ν.ΑΤΤΙΚΟΝ (site 635-009) : Καθηγήτρια Αναστασία Αντωνιάδου (ananto@med.uoa.gr)

Νόσημα : Ιογενείς λοιμώξεις αναπνευστικού σε νοσηλευόμενους ασθενείς

Inclusion citeria

• Age ≥18 years
• Admission to hospital
• Signed informed consent by participant or surrogate/representative
• Local diagnosis (confirmed or suspected) of influenza or of a targeted non-influenza vial respiratory infection, resulting in (or extending a previous) hospitalization

Exclusion criteria

• Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness

2. Tίτλος μελέτης : An International Observational Study of Outpatients with SARS-CoV-2 Infection Short title: International SARS-CoV-2 Infection Observational Study (ICOS) INSIGHT Protocol Number 011
Funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and Carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Sponsor: University of Minnesota

Κύριος ερευνητής για το Παν. Γ.Ν.ΑΤΤΙΚΟΝ (site 635-009) : Καθηγήτρια Αναστασία Αντωνιάδου (ananto@med.uoa.gr)

Νόσημα : Νόσος COVID-19 σε μη νοσηλευόμενους ασθενείς

Inclusion Criteria

• 18 years of age
• Not hospitalized
• Signed informed consent.

Exclusion Criteria

• Persons with a known positive SARS-CoV-2 test > 28 days ago.

3. Tίτλος μελέτης : A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19. Short Title: Therapeutics for Inpatients with COVID-19 (TICO)
INSIGHT Protocol Number: 014 / ACTIV-3. NCT 04501978, EudraCT 2020-003278-37
Funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

Κύριος ερευνητής για το Παν. Γ.Ν.ΑΤΤΙΚΟΝ (site 635-009) : Καθηγήτρια Αναστασία Αντωνιάδου (ananto@med.uoa.gr)

Νόσημα : Νόσος COVID-19 σε νοσηλευόμενους ασθενείς. Χρήση μονοκλωνικών αντισωμάτων σαν συμπληρωματική θεραπεία

Inclusion Criteria

• Age ≥ 18 years
• Informed consent by the patient or the patient’s legally-authorized representative (LAR)
• SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests will be maintained.)
• Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator
• Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.

Exclusion Criteria

• Prior receipt of : a)Any SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19 or b)SARS-CoV-2 nMAb at any time prior to hospitalization
• Not willing to abstain from participation in other COVID-19 treatment trials until after Day 5
• In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments
• Expected inability to participate in study procedures
• Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study.
• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study.

4. Tίτλος μελέτης : An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19. Short Title: Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC). INSIGHT Protocol Number: 012
Funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Sponsor: University of Minnesota

Κύριος ερευνητής για το Παν. Γ.Ν.ΑΤΤΙΚΟΝ (site 635-009) : Καθηγήτρια Αναστασία Αντωνιάδου (ananto@med.uoa.gr)

Νόσημα : Πρώιμη νόσος COVID-19 σε μή νοσηλευόμενους ασθενείς. Χρήση υπερανόσου ανοσοσφαιρινης σαν θεραπεία

Inclusion Criteria

• Positive test for SARS-CoV2 by nucleic acid amplification test (NAAT), or a non-NAAT test that is approved by protocol team, within ≤4 days.
• Within ≤4 days from symptom onset if symptomatic from COVID-19.
• Clinical risk defined by either age ≥55 years or adults (age ≥18 years) with an immunosuppressed condition or immunosuppressive treatment.
• Participant status must meet criteria for category 1, 2 or 3 on the ordinal outcome scale, and if a chest x-ray is obtained for clinical reasons (not required for screening) it should not show evidence of new infiltrates consistent with pneumonia.
• Agrees to not participate in another clinical trial for the treatment of SARS-CoV-2 infection through day 7 or until hospitalized or other criteria for significant disease progress (defined by ordinal scale 4 or 5).
• Participant understands and agrees to comply with planned study procedures.
• Participant provides written informed consent prior to study procedures.
  
  Exclusion Criteria
  
• Prior receipt of immunoglobulin product in the past 90 days, including SARS-CoV-2 hIVIG or convalescent plasma, as well as any IVIG.
• Experiencing criteria listed in category 4 or 5 of the ordinal outcome scale, or being admitted to the hospital. For clarity, this criteria is not met for participants admitted to a health facility solely for public health purposes of quarantine or observation without medical care.
• Thrombosis within 28 days of randomization, including acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis.
• Any of the following procoagulant disorders: prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome
• A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis.
• Medical conditions for which receipt of a 300 mL volume of intravenous fluid may be dangerous to the patient (e.g., decompensated congestive heart failure).
• History of hypersensitivity to blood, plasma or IVIG excipients.
• Known IgA deficiency or anti-IgA antibodies.

5. Tίτλος μελέτης : A randomized, double-blind, multi-center study to establish the efficacy and safety of ceftobiprole medocaril compared to daptomycin in the treatment of Staphylococcus aureus bacteremia, including infective endocarditis. BPR-CS-009 (ERADICATE) EudraCT: 2017-001699-43
Funded by Basilea Pharmaceutica Ltd

Κύριος ερευνητής για το Παν. Γ.Ν.ΑΤΤΙΚΟΝ (site 264) : Καθηγήτρια Αναστασία Αντωνιάδου (ananto@med.uoa.gr)

Νόσημα : Επιπεπλεγμένη βακτηριαιμία από S.aureus (συμπεριλαμβανομένης ενδοκαρδίτιδας δεξιών κοιλοτήτων). Δοκιμή μιας νέας κεφαλοσπορίνης 5ης γενιάς (κεφτοπιπρόλης) σαν θεραπεία και σε σύγκριση με δαπτομυκίνη

Inclusion criteria

• Male or female ≥ 18 years of age.
• Informed consent signed by the patient (or by their legally acceptable representative, if appropriate) indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study.
• SAB, based on at least one S. aureus positive blood culture obtained within the 72h prior to randomization: a) identified by culture laboratory report, or b) positive diagnostic test for S. aureus (e.g., polymerase chain reaction [PCR], tube coagulase test and fluorescent in situ hybridization [FISH]) obtained from a blood culture.
• At least one of the following signs or symptoms of bacteremia, within 72 h prior to randomization (may be based on measurements obtained before or after informed consent but within 72h prior to randomization):
  • Fever : a)≥ 38°C/100.4 °F measured orally, b)> 38.5 °C / 101.3 °F measured tympanically, c)> 37.5 °C / 99.5 °F measured by axillary method d)> 39 °C / 102.2 measured rectally
  • white blood cell (WBC) count > 10.0 or < 4.0 × 109/L, or > 10% immature neutrophils (bands)
  • tachycardia (heart rate > 90 bpm)
  • hypotension (systolic blood pressure < 90 mmHg)
• Required duration of study antibacterial treatment ≤ 28 days.
• SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis
• Persistent SAB: documented failure of bloodstream clearance, defined as a positive blood culture for S. aureus within the 72 h prior to randomization, after prior appropriate anti-staphylococcal treatment (except failure under daptomycin therapy) of at least 3 complete days.
• Other forms of complicated SAB, including the following : a)Acute bacterial skin or skin-structure infections (ABSSSIs) b)Metastatic infection of native tissue requiring ≤ 28 days of study antibacterial treatment.
• Definite native-valve right-sided Infectious Endocarditis (RIE) by Modified Duke’s Criteria if both of the following conditions are met: a)Absence of clinical and/or radiological evidence of cerebral foci b)Absence of other complications requiring more than 28 days of antibacterial treatment.
  
  Exclusion criteria
  
• Treatment with potentially effective (anti-staphylococcal) systemic antibacterial treatment for more than 48 h within the 7 days prior to randomization
• Exception: Documented failure of bloodstream clearance with prior antistaphylococcal treatment (except failure under daptomycin therapy) administered for at least 3 complete days.
• Bloodstream or non-bloodstream concomitant infections with Gram-negative bacteria that are known (at Screening) to be non-susceptible to either ceftobiprole or aztreonam.
• Confirmed uncomplicated SAB (e.g., catheter-related non-persistent SAB without signs of SAB complications, unless the patient has end-stage renal disease and is on intermittent hemodialysis or peritoneal dialysis)
• Left sided infective endocarditis
• Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic implantable cardioverter-defibrillator, or left-ventricular assist devices.
• Complicated SAB in patients with other foreign body material that cannot be removed within the 7 days after randomization
• Cardiac native-valve surgery planned within 3 days after randomization.
• Community- or hospital-acquired pneumonia
• Osteomyelitis (including vertebral, sternal or long-bone osteomyelitis).
• Epidural or cerebral abscess
• High probability of death within 7 days due to the underlying SAB or SAB-associated disease, or high probability of death within 28 days from an unrelated underlying disease.
• Clinically-relevant hypersensitivity to β-lactam antibacterials or daptomycin
• Known infection due to Staphylococcus aureus that exhibits reduced susceptibility to daptomycin (minimum inhibitory concentration [MIC] > 1 mg/L), or ceftobiprole (MIC > 2 mg/L)
• Absolute neutrophil count < 0.5 × 109/L.
• Either a)a history of opportunistic infections (e.g., invasive fungal infections or cytomegalovirus [CMV]) within 30 days prior to randomization, where the underlying cause of these infections is still active (e.g., leukemia, transplant, acquired immunodeficiency syndrome [AIDS]) b) CD4 count < 100 cells/mm3 in patients with AIDS c)patients treated with cotrimoxazole as prophylaxis for pneumocystis pneumonia
• Requirement or expected requirement between randomization and the PTE visit for potentially effective (anti-staphylococcal) systemic antibacterial treatment that is unrelated to the treatment of SAB
• Requirement for continuous renal-replacement therapy at the time of randomization, or high likelihood of requirement for continuous renal-replacement therapy during the study period (Note: Patients undergoing chronic intermittent hemodialysis or peritoneal dialysis are permitted to participate in the study)
• Alanine transaminase (ALT) or aspartate transaminase (AST) levels ≥ 8 × the upper limit of normal, or severe hepatic disease with Child-Pugh class C
• Women who are pregnant or nursing
• Women who are of childbearing potential and unwilling to use an acceptable method of birth control during the study
• Use of an investigational non-FDA approved drug in a Phase 1 study within the 30 days prior to the start of study treatment

6. Tίτλος μελέτης : A Phase II randomized, single-blind dose Study to evaluate the safety and efficacy of exosomes overexpressing CD24(EXO-CD24, CovenD24) of two doses, Dose 1 – 109 exosome particles versus Dose 2 – 1010 exosome particles, for the prevention of clinical deterioration in patients with Moderate or Severe COVID-19. Protocol number : NS3

EuDRACT No.: 2021-002184-22
Sponsor : Athens Medical Society

Κύριος ερευνητής για το Παν. Γ.Ν.ΑΤΤΙΚΟΝ : Καθηγητής Σωτήριος Τσιόδρας (tsiodras@med.uoa.gr)
Συν-ερευνητής: Καθηγήτρια Αναστασία Αντωνιάδου (ananto@med.uoa.gr)

Νόσημα : Νόσος COVID-19 σε νοσηλευόμενους ασθενείς

Κριτήρια ένταξης

• Διάγνωση COVID-19 που επιβεβαιώθηκε με δοκιμασία αλυσιδωτής αντίδρασης πολυμεράσης (PCR) για SARS- CoV 2 , εντός 30 ημερών.
• Ηλικία 18-80 ετών.
• Σοβαρότητα της νόσου σύμφωνα με τα ακόλουθα κριτήρια (απαιτούνται τουλάχιστον μία κλινική και μία εργαστηριακή παράμετρος) :
  
  Α. Κλινική και βασισμένη στην απεικόνιση αξιολόγηση (ONE)
  i) Ρυθμός αναπνοής> 23 / min και <30 / min ή
  ii) SpO2 at room air ≤94% και ≥90% ή
  iii) Αμφοτερόπλευρα πνευμονικά διηθήματα > 25% εντός 24-48 ωρών από την εισαγωγή, ή σοβαρή επιδείνωση σε σύγκριση με την απεικόνιση κατά την εισαγωγή
  
• Στοιχεία μιας επιδεινωμένης φλεγμονώδους διαδικασίας (ONE):
  i)LDH ≥300 U / L ή ποιο είναι το ανώτερο όριο για φυσιολογικό ανά ηλικία ή
  ii)CRP ≥25mg/L ή
  iii)Φεριττίνη ≥500 ng/ ml ή
  iv)Λεμφοκύτταρα <800 cells / mm3 ή
  v)D-dimmers ≥500 ng/ ml
• Πρόθυμος και ικανός να υπογράψει μια ενημερωμένη συγκατάθεση
  
  Κριτήρια αποκλεισμού
  
• Οποιαδήποτε ταυτόχρονη ασθένεια που, βάσει της κρίσης του ερευνητή μπορεί να επηρεάσει τα αποτελέσματα της μελέτης ή την ερμηνεία τους (π.χ. ανοσοανεπάρκεια)
• Μηχανικά αεριζόμενος ασθενής ή ασθενής που πιθανότατα θα απαιτήσει εισαγωγή σε ΜΕΘ ή μηχανικό αερισμό εντός 24 ωρών από την εγγραφή, σύμφωνα με την κρίση του ερευνητή
• Προηγούμενος πλήρης ή μερικός εμβολιασμός για το SARS-CoV-2
• Κύηση [θετικό τεστ εγκυμοσύνης στα ούρα (μόνο σε γυναίκες με δυνατότητα τεκνοποίησης)] ή θηλασμός
• Συμμετοχή σε οποιαδήποτε άλλη επεμβατική μελέτη τις τελευταίες 30 ημέρες
• Ενεργός καρκίνος
  
  Η ανωτέρω μελέτη φάσης ΙΙ ολοκλήρωσε την προγραμματισμένη ένταξη ασθενών στις 4/8/2021 και αναμένονται τα αποτελέσματά της μετά τις 15/9/2021, όπως και η αναμενόμενη σχετική μελέτη φάσης ΙΙΙ

7. Σε φάση ενεργοποίησης βρίσκεται η κλινική μελέτη με τίτλο : A multicenter, Phase III Randomized, Double-blind, Placebo-controlled, Outpatient study to evaluate the efficacy, safety, and antiviral activity of RO7496998 (AT-527) in patients with mild or moderate covid-19.
H μελέτη θα αφορά ασθενείς που δεν νοσηλεύονται στο νοσοκομείο με πρώιμη νόσο COVID-19
Study sponsor : F. Hoffmann-La Roche Ltd
Θα ενημερωθείτε για τα κριτήρια ένταξης στη μελέτη μόλις οριστικοποιηθεί η ενεργοποίηση του κέντρου στο Παν. Γ.Ν.ΑΤΤΙΚΟΝ με κύρια ερευνήτρια την Καθηγήτρια Αναστασία Αντωνιάδου