- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04712344
Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO) (IPCO)
Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19
연구 개요
상세 설명
The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.
The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.
As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.
The study design will be prospective, open-label, randomized, controlled and parallel-grouped.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
-
Erlangen, 독일
- 모병
- University Hospital Erlangen
-
연락하다:
- Carsten Willam, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female subject aged ≥18 years.
- Estimated BMI ≥19kg/m² to ≤40kg/m².
- Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
- ARDS with Horovitz index <300mmHg.
- Necessity of invasive mechanical ventilation.
- Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
- Subject's assent if obtainable
Exclusion Criteria:
- Previous exposure to COVID-19 convalescent plasma.
- Adverse reaction to plasma proteins in medical history.
- Interval >72h since endotracheal intubation.
- Current or imminent necessity of ECMO treatment.
- Pre-existing COPD GOLD stage 4.
- Chronic congestive heart failure NYHA ≥3.
- Pre-existing left ventricular ejection fraction <30%.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: COVID-19 convalescent plasma
A total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 and standard treatment.
|
Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.
|
간섭 없음: Standard treatment
Standard treatment.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in SOFA score from Baseline Visit
기간: [Day 1, Visit 2] to Day 8 [Visit 9]
|
Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data.
SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets.
All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score.
The lower the SOFA score, the better is the prognosis (Maximum value 24)
|
[Day 1, Visit 2] to Day 8 [Visit 9]
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean number of days without invasive mechanical ventilation during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject. Time from Baseline Visit [Day 1, Visit 2] to extubation. |
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of mortality during defined time-frame
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Number of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Proportion of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean number of days without supplemental oxygen during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean relative change of PEEP from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean relative change of FiO2 from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Mean relative change of driving pressure from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19
기간: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
Time from Baseline Visit [Day 1, Visit 2] to stop of invasive mechanical ventilation.
|
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Carsten Willam, MD, University Hospital Erlangen
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- UKER-COV2-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심각한 COVID-19에 대한 임상 시험
-
Yang I. Pachankis모집하지 않고 적극적으로COVID-19 호흡기 감염 | COVID-19 스트레스 증후군 | COVID-19 백신 부작용 | COVID-19 관련 혈전색전증 | COVID-19 집중 치료 후 증후군 | COVID-19 관련 뇌졸중중국
-
Endourage, LLC모병긴 COVID | 긴 Covid19 | 포스트 급성 COVID-19 | 장거리 COVID | 장거리 COVID-19 | COVID-19 후 증후군미국
-
Massachusetts General Hospital모병
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of Ioannina모병COVID-19 폐렴 | COVID-19 호흡기 감염 | 코로나19 감염병 세계적 유행 | COVID-19 급성호흡곤란증후군 | COVID-19 관련 폐렴 | COVID 19 관련 응고병증 | COVID-19(코로나바이러스 질병 2019) | COVID-19 관련 혈전색전증그리스
-
Jonathann Kuo, MD모집하지 않고 적극적으로SARS-CoV2 감염 | 코로나19 이후 증후군 | 자율신경실조증 | 급성 COVID-19 후 증후군 | 긴 COVID | 긴 Covid19 | COVID-19 재발 | 포스트 급성 COVID-19 | 급성 COVID-19 감염 후 | COVID-19의 급성 후유증 | 자율신경실조증 유사 장애 | 자율신경실조증 기립성 저혈압 증후군 | COVID-19 이후 상태 | 포스트 코로나 증후군 | COVID-19 이후 상태, 지정되지 않음미국
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention...완전한
-
Patrick Robinson모병코로나19 | COVID-19 폐렴 | COVID-19 호흡기 감염 | COVID-19 급성 기관지염미국
-
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.완전한
-
Timothy HenrichShionogi Inc.초대로 등록긴 COVID | 포스트 급성 COVID-19 | COVID-19의 급성 후유증미국
COVID-19 convalescent plasma에 대한 임상 시험
-
Raphael SerreauAssistance Publique - Hôpitaux de Paris; University Hospital, Paris; François Rabelais University완전한
-
Scripps Translational Science InstituteCue Health모병
-
San Diego State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
St. Joseph's Healthcare HamiltonTimothy O'Shea; Marek Smieja; Lawrence Mbuagbaw알려지지 않은