- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05074420
COVID-19(COV-BARRIER-PEDS)에 걸린 어린이의 바리시티닙(LY3009104)에 대한 연구 (COV-BARRIER)
COVID-19로 입원한 1세에서 18세 미만의 소아 환자를 대상으로 한 바리시티닙의 다기관, 공개 라벨, 약동학 및 안전성 연구
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Mexico City, 멕시코, 04530
- Instituto Nacional de Pediatría
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Mexico City, 멕시코, 06720
- Hospital Infantil de México Federico Gómez
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Florida
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Orlando, Florida, 미국, 32806
- Arnold Palmer Hospital for Children
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Michigan
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Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
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Campinas, 브라질, 13060-080
- Instituto de Pesquisa Clínica de Campinas
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Campinas, 브라질, 13034-685
- Centro de Pesquisa São Lucas
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Jaú, 브라질, 17201130
- CECIP - Centro de Estudos do Interior Paulista
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Porto Alegre, 브라질, 90410000
- Hospital de Clinicas de Porto Alegre
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Santo André, 브라질, 09080-110
- Pesquisare Saúde
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Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Pamplona, 스페인, 31009
- Complejo Hospitalario de Navarra
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Vitoria-Gasteiz, 스페인, 01009
- Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 코로나바이러스(SARS-CoV-2) 감염으로 입원했습니다.
- 1세에서 18세 미만의 남성 또는 여성 참가자.
- 연구 시작 및 등록 후 72시간 이내에 COVID-19로 인한 호흡기 질환을 확인하기 위해 보충 산소가 필요하고 흉부 영상 소견이 있어야 합니다.
- 비강 캐뉼라, 마스크, 고유량 장치, CPAP/BiPAP, 침습적 기계 환기 및 ECMO를 포함하되 이에 국한되지 않는 보충 산소.
제외 기준:
- 생물학적 치료(예: 종양괴사인자[TNF] 억제제, 인터루킨 억제제, T 세포 또는 B 세포 표적 요법, 인터페론 또는 야누스 키나아제(JAK) 억제제)를 받고 있습니다. 또는 연구자의 의견에 따라 연구에 참여하는 것이 참가자를 허용할 수 없는 면역억제 위험에 놓이게 하는 다른 면역억제제를 투여받고 있습니다.
참고: 스크리닝 전에 워시아웃 기간이 필요합니다.
- 연구 시작 시 중단할 수 없는 유기 음이온 수송체 3(OAT3)의 강력한 억제제(예: 프로베네시드)를 받고 있습니다.
- 현재 활동성 결핵(TB) 진단을 받았거나 알려진 경우 현지 가이드라인에 따라 적절한 항결핵 요법으로 4주 미만 동안 치료받은 잠복성 결핵을 가지고 있어야 합니다(이력에 의해서만 선별 검사가 필요하지 않음).
- 조사자의 의견에 따라 조사 제품을 복용할 때 위험을 구성할 수 있는 의심되는 심각한 활성 세균, 진균, 바이러스 또는 기타 감염(COVID-19 제외).
- 스크리닝 전 4주 이내에 생백신을 받았거나 연구 중에 생백신을 받을 의도가 있는 자. 참고: 비생(비활성화) 백신 사용은 모든 참가자에게 허용됩니다.
- 연구 시작 시 체외막산소화(ECMO)를 포함한 침습적 기계적 환기가 필요합니다.
- 연구자의 의견에 따라 연구 제품을 복용할 때 위험을 구성할 수 있는 활동성 악성 종양의 현재 진단.
- 정맥혈전색전증(VTE)(심부정맥혈전증[DVT] 및/또는 폐색전증[PE]) 병력이 있거나 VTE(DVT/PE) 위험이 높은 것으로 간주됩니다.
- 연구 시작 후 72시간 이내에 연구 장소가 아닌 다른 병원(또는 다른 단위)으로 병원에서 퇴원할 것으로 예상됩니다.
- 호중구 감소증(절대 호중구 수 <1000 세포/마이크로리터)이 있습니다.
- 림프구 감소증(절대 림프구 수 <200 세포/마이크로리터)이 있습니다.
- ALT(alanine aminotransferase) 또는 AST(aspartate aminotransferase)가 AAULN의 5배 이상이어야 합니다.
- 예상 사구체 여과율(eGFR)(신장 질환의 식단 수정[MDRD]) <40밀리리터/분/1.73제곱미터.
- 바리시티닙 또는 그 부형제에 알려진 과민증이 있습니다.
- 현재 연구 제품과 관련된 다른 임상 연구 또는 과학적 또는 의학적으로 이 연구와 양립할 수 없다고 판단되는 다른 유형의 의학 연구에 등록되어 있습니다. 참고: 참가자는 28일까지 COVID-19 또는 SARS CoV-2 치료를 위한 다른 임상 시험에 등록(시작)해서는 안 됩니다.
- 임신 중이거나 임신을 계획 중이거나 연구 기간 동안 수유 중인 경우.
- 조사자 또는 후원자의 의견에 따라 면역억제 위험이 있거나 연구에 포함하기에 적합하지 않은 경우.
- 사이토카인 흡수 또는 필터링 장치, 예를 들어 CytoSorb®와 같은 혈액에서 전염증성 사이토카인을 제거하기 위해 체외 혈액 정화(EBP) 장치를 사용 중이거나 사용할 예정입니다.
- 조사자의 의견으로는 스크리닝 후 최소 48시간 동안 생존할 가능성이 없습니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Baricitinib QD
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구두로 주어진
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib
기간: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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PK: Overall AUC of Baricitinib in pediatric participants with COVID-19.
Summarized data were reported in this outcome measure.
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Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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PK: Maximum Concentration (Cmax) of Baricitinib
기간: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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PK: Overall Cmax of Baricitinib in pediatric participants with COVID-19.
Summarized data were reported in this outcome measure.
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Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Who Progressed to Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) by Day 28
기간: Day 1 to Day 28
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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
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Percentage of Participants Who Died or Progressed to Non-Invasive Ventilation/High-Flow Oxygen, Invasive Mechanical Ventilation, or ECMO by Day 28
기간: Day 1 to Day 28
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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
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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
기간: Day 4, Day 7, Day 10, Day 14, and Day 28
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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
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Number of Ventilator-Free Days (Days Free of Invasive Mechanical Ventilation)
기간: Day 1 to Day 28
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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
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Time to Recovery
기간: Day 1 to Day 28
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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
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
기간: Day 4
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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
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
기간: Day 7
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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
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
기간: Day 10
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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
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
기간: Day 14
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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
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28
기간: Day 28
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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
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Duration of Hospitalization
기간: Day 1 to Day 28
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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
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All-Cause Mortality
기간: Baseline (Day 1) up to end of follow-up (up to Day 60)
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Number of deaths by day 60 were reported in this outcome measure.
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Baseline (Day 1) up to end of follow-up (up to Day 60)
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Duration of Stay in the Intensive Care Unit (ICU) in Days
기간: Day 1 to Day 28
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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).
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Day 1 to Day 28
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공동 작업자 및 조사자
수사관
- 연구 책임자: 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
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 18253
- I4V-MC-KHAB (기타 식별자: Eli Lilly and Company)
- 2021-001338-21 (EudraCT 번호)
- 2024-516824-32-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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