Uno studio su Baricitinib (LY3009104) nei bambini con COVID-19 (COV-BARRIER-PEDS) (COV-BARRIER)
Uno studio multicentrico, in aperto, di farmacocinetica e sicurezza di Baricitinib in pazienti pediatrici da 1 anno a meno di 18 anni ricoverati in ospedale con COVID-19
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 3
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Numero di telefono: 1-317-615-4559
- Email: LillyTrials@Lilly.com
Backup dei contatti dello studio
- Nome: Physicians interested in becoming principal investigators please contact
- Email: clinical_inquiry_hub@lilly.com
Luoghi di studio
-
-
-
Campinas, Brasile, 13060-080
- Instituto de Pesquisa Clínica de Campinas
-
Campinas, Brasile, 13034-685
- Centro de Pesquisa São Lucas
-
Jaú, Brasile, 17201130
- CECIP - Centro de Estudos do Interior Paulista
-
Porto Alegre, Brasile, 90410000
- Hospital de Clinicas de Porto Alegre
-
Santo André, Brasile, 09080-110
- Pesquisare Saúde
-
-
-
-
-
Mexico City, Messico, 04530
- Instituto Nacional de Pediatría
-
Mexico City, Messico, 06720
- Hospital Infantil de México Federico Gómez
-
-
-
-
-
Madrid, Spagna, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spagna, 28046
- Hospital Universitario La Paz
-
Pamplona, Spagna, 31009
- Complejo Hospitalario de Navarra
-
Vitoria-Gasteiz, Spagna, 01009
- Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
-
-
-
-
Florida
-
Orlando, Florida, Stati Uniti, 32806
- Arnold Palmer Hospital for Children
-
-
Michigan
-
Detroit, Michigan, Stati Uniti, 48201
- Children's Hospital of Michigan
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals Cleveland Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Descrizione
Criterio di inclusione:
- Ricoverato in ospedale con infezione da coronavirus (SARS-CoV-2).
- Partecipanti di sesso maschile o femminile da 1 a <18 anni di età.
- Richiede ossigeno supplementare e dispone di risultati di imaging del torace per confermare la malattia respiratoria dovuta a COVID-19 entro 72 ore dall'ingresso nello studio e dall'arruolamento.
- Ossigeno supplementare incluso ma non limitato a: cannula nasale, maschera, dispositivi ad alto flusso, CPAP/BiPAP, ventilazione meccanica invasiva e ECMO.
Criteri di esclusione:
- stanno ricevendo trattamenti biologici (come inibitori del fattore di necrosi tumorale [TNF], inibitori dell'interleuchina, terapie mirate alle cellule T o B, interferone o inibitori della Janus chinasi (JAK)); o stanno ricevendo altri immunosoppressori tali che, a parere dello sperimentatore, la partecipazione allo studio esporrebbe il partecipante a un rischio inaccettabile di immunosoppressione.
Nota: è necessario un periodo di washout prima dello screening.
- Ricevono forti inibitori di Organic Anion Transporter 3 (OAT3) (come probenecid) che non possono essere interrotti all'ingresso nello studio.
- Avere una diagnosi di tubercolosi attiva in corso (TB) o, se nota, tubercolosi latente trattata per meno di 4 settimane con un'appropriata terapia anti-tubercolosi secondo le linee guida locali (solo per anamnesi, non sono richiesti test di screening).
- Sospetta infezione batterica, fungina, virale o di altro tipo attiva grave e attiva (oltre a COVID-19) che, a parere dello sperimentatore, potrebbe costituire un rischio durante l'assunzione del prodotto sperimentale.
- - Avere ricevuto un vaccino vivo entro 4 settimane prima dello screening o se si intende ricevere un vaccino vivo durante lo studio. Nota: l'uso di vaccinazioni non vive (inattivate) è consentito a tutti i partecipanti.
- Richiedere ventilazione meccanica invasiva, inclusa l'ossigenazione extracorporea a membrana (ECMO) all'ingresso nello studio.
- - Diagnosi attuale di malignità attiva che, a parere dello sperimentatore, potrebbe costituire un rischio durante l'assunzione del prodotto sperimentale.
- Avere una storia di tromboembolia venosa (TEV) (trombosi venosa profonda [TVP] e/o embolia polmonare [EP]) o considerato ad alto rischio di TEV (TVP/EP).
- Dimissione anticipata dall'ospedale o trasferimento in un altro ospedale (o un'altra unità), che non è un centro di studio entro 72 ore dall'ingresso nello studio.
- Avere neutropenia (conta assoluta dei neutrofili <1000 cellule/microlitri).
- Avere linfopenia (conta assoluta dei linfociti <200 cellule/microlitri).
- Avere alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) >5 volte AAULN.
- Velocità di filtrazione glomerulare stimata (eGFR) (Modifica della dieta nelle malattie renali [MDRD]) <40 millilitri/minuto/1,73 metri quadrati.
- Avere una nota ipersensibilità al baricitinib o ad uno qualsiasi dei suoi eccipienti.
- Sono attualmente iscritti a qualsiasi altro studio clinico che coinvolga un prodotto sperimentale o qualsiasi altro tipo di ricerca medica giudicato non compatibile dal punto di vista scientifico o medico con questo studio. Nota: il partecipante non deve essere arruolato (iniziato) in un altro studio clinico per il trattamento di COVID-19 o SARS CoV-2 fino al giorno 28.
- Sono incinte o intendono rimanere incinte o allattare durante lo studio.
- Sono, secondo l'opinione dello sperimentatore o dello sponsor, a rischio di immunosoppressione o altrimenti non idonei per l'inclusione nello studio.
- Utilizza o utilizzerà un dispositivo di purificazione extracorporea del sangue (EBP) per rimuovere le citochine proinfiammatorie dal sangue come un dispositivo di assorbimento o filtraggio delle citochine, ad esempio CytoSorb®.
- Secondo l'investigatore, è improbabile che sopravvivano per almeno 48 ore dopo lo screening.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Baricitinib QD
|
Dato oralmente
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib
Lasso di tempo: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
|
PK: Overall AUC of Baricitinib in pediatric participants with COVID-19.
Summarized data were reported in this outcome measure.
|
Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
|
|
PK: Maximum Concentration (Cmax) of Baricitinib
Lasso di tempo: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
|
PK: Overall Cmax of Baricitinib in pediatric participants with COVID-19.
Summarized data were reported in this outcome measure.
|
Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Who Progressed to Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) by Day 28
Lasso di tempo: Day 1 to Day 28
|
NIAID-OS is an assessment of clinical status. The scale is as follows: 1)Not hospitalized, no limitations on activities; 2)Not hospitalized, limitation on activities and/or requiring home oxygen; 3)Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4)Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5)Hospitalized, requiring supplemental oxygen; 6)Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7)Hospitalized, on invasive mechanical ventilation or ECMO; 8)Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Progression to ventilation (only progressed excluding death) by Day 28 was defined as reaching NIAID-OS ≥6; for participants with baseline NIAID-OS 6, progression required NIAID-OS ≥7, and those with a baseline score of 7 were excluded. |
Day 1 to Day 28
|
|
Percentage of Participants Who Died or Progressed to Non-Invasive Ventilation/High-Flow Oxygen, Invasive Mechanical Ventilation, or ECMO by Day 28
Lasso di tempo: Day 1 to Day 28
|
NIAID-OS is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Progression to ventilation (who died or progressed) by Day 28, defined as reaching a score ≥6; for baseline scores of 6 and 7, progression required scores ≥7 and Death (NIAID-OS=8). |
Day 1 to Day 28
|
|
Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital
Lasso di tempo: Day 4, Day 7, Day 10, Day 14, and Day 28
|
NIAID-OS is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. At each visit (Day 4/7/10/14/28), percentage of participants with ≥1-point improvement on NIAID-OS or discharged alive by that visit were reported in this outcome measure. |
Day 4, Day 7, Day 10, Day 14, and Day 28
|
|
Number of Ventilator-Free Days (Days Free of Invasive Mechanical Ventilation)
Lasso di tempo: Day 1 to Day 28
|
NIAID-OS is an assessment of clinical status. The 8-point scale as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Number of ventilator free-days were defined as total number of days participants were alive and had NIAID-OS <7 point (free of invasive mechanical ventilation/ECMO) by Day 28. |
Day 1 to Day 28
|
|
Time to Recovery
Lasso di tempo: Day 1 to Day 28
|
NIAID-OS is an assessment of clinical status. The 8-point scale as follows:1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Time to recovery was time from Day 1 to the first day the participant's maximum daily NIAID-OS was 1, 2, or 3. Participants who died before recovery were censored at Day 28 (not considered recovered). |
Day 1 to Day 28
|
|
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Lasso di tempo: Day 4
|
NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 4 score. A higher positive value indicates greater improvement. |
Day 4
|
|
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Lasso di tempo: Day 7
|
NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 7 score. A higher positive value indicates greater improvement. |
Day 7
|
|
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Lasso di tempo: Day 10
|
NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 10 score. A higher positive value indicates greater improvement. |
Day 10
|
|
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Lasso di tempo: Day 14
|
NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 14 score. A higher positive value indicates greater improvement. |
Day 14
|
|
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28
Lasso di tempo: Day 28
|
NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 28 score. A higher positive value indicates greater improvement. |
Day 28
|
|
Duration of Hospitalization
Lasso di tempo: Day 1 to Day 28
|
NIAID-OS is an assessment of clinical status. The 8-point scale as follows:1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care; 5)Hospitalized, requiring supplemental oxygen; 6)Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7)Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range:1-8); minimum value:1; maximum value:8; higher scores indicate worse clinical status. Duration of hospitalization through Day 28 was defined as the total number of days with NIAID-OS scores of 4, 5, 6, or 7. Participants who died on or before Day 28 were assigned 28 days. For Day 1, hospitalization status was determined using worst NIAID-OS value recorded between baseline and the remainder of Day 1. |
Day 1 to Day 28
|
|
All-Cause Mortality
Lasso di tempo: Baseline (Day 1) up to end of follow-up (up to Day 60)
|
Number of deaths by day 60 were reported in this outcome measure.
|
Baseline (Day 1) up to end of follow-up (up to Day 60)
|
|
Duration of Stay in the Intensive Care Unit (ICU) in Days
Lasso di tempo: Day 1 to Day 28
|
Duration of ICU stay through Day 28 was defined as the total number of days spent in the ICU through Day 28, with days following death counted up to Day 28.
For participants alive at Day 28, duration was calculated as (Date of ICU discharge - Date of ICU admission) + 1.
For participants who died in the ICU on or before Day 28, duration was calculated as (Date of death - Date of ICU admission + 1) + (Date of Day 28 - Date of death).
|
Day 1 to Day 28
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 18253
- I4V-MC-KHAB (Altro identificatore: Eli Lilly and Company)
- 2021-001338-21 (Numero EudraCT)
- 2024-516824-32-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .