Safety and Effectiveness of an Immunobiological Drug in CoViD-19 (INPB001)
2021년 9월 11일 업데이트: Guillermo Alberto Keller, Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran
Study to Evaluate the Safety and Effectiveness of an Immunobiological Drug (Anti SARS-CoV-2) in the Treatment of Coronavirus Disease 2019 (CoViD-19)
The aims of this study is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbrán) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection aged 18 to 80 years.
연구 개요
상세 설명
This is an adaptive phase II/III study that aims to analyze the efficacy and safety of a immunobiological drug (Anti SARS-CoV-2) in the treatment of CoViD-19. This treatment is a passive immunotherapy strategy developed as a purified F(ab')2 fraction of equine hyperimmune serum (Anti-SARS-CoV-2). The equine serum was generated from antigenic stimulation with the SARS-CoV-2 receptor binding domain (RBD) purified protein.
This type of product (equine hyperimmune serum F(ab')2) has been widely used in our country in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as anti-loxosceles, anti -latrodectus, anti-scorpionic, and anti-phoneutria, anti-bothropic, anti-micrurus, and anti-crotalic sera, all developed by the National Institute of Biological Production (ANLIS-Malbrán) and distributed free of charge in public hospitals in the country .
In the present study, evaluates the effect and safety of this immunobiological treatment in patients with COVID-19 that require hospitalization.
연구 유형
중재적
등록 (예상)
200
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Guillermo A Keller, MD PhD
- 전화번호: 011-4961-0943
- 이메일: gkeller@anlis.gob.ar
연구 연락처 백업
- 이름: Claudio Bonel, PhD
- 전화번호: 011-4303-1801
- 이메일: cbonel@anlis.gob.ar
연구 장소
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Ciudad Autónoma De Buenos Aires, 아르헨티나, 1408
- 모병
- Hospital General de Agudos Donación Francisco J. Santojanni
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연락하다:
- Guillermo A Keller, MD PhD
- 전화번호: 01149610943
- 이메일: gkeller@anlis.gob.ar
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연락하다:
- Claudio Bonel, PhD
- 전화번호: 011-4303-2492
- 이메일: cbonel@anlis.gob.ar
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수석 연구원:
- Guillermo A Keller, MD PhD
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부수사관:
- Guillermo Di Girolamo, MD PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects over 18 years old and under 80 years old.
- Positive results by RT-PCR for SARS CoV-2
- Clinical picture compatible with respiratory compromise in the form of pneumonia attributed to COVID-19 (Stage 3, 4 or 5 according to the WHO scale), lasting up to 72 hours from the onset of symptoms to their evaluation to be incorporated into the study.
- Patient with good disposition towards the study and that signs the informed consent.
Exclusion Criteria:
- Patients with clinical disease corresponding to mild / asymptomatic forms (Absence of radiological infiltrate and risk factors, with normal auscultation and arterial saturation of oxygen (SatO2) greater than 95%)
- Patients with clinical disease corresponding to severe forms (Severe pneumonia: presence of severity criteria (ATS / IDSA), one of two major or three minor criteria.)
- Patients who have received other therapeutic strategies in the framework of an experimental study that make it difficult to evaluate the results obtained, including (but not limited to): convalescent plasma, lopinavir / ritonavir, hydroxychloroquine, and azithromycin.
- Pregnant or lactating women.
- Women of childbearing potential not using an effective contraceptive method (withdrawal, intrauterine device, or oral contraceptives).
- History of severe anaphylactic reaction with the administration of equine plasma.
- Patients with comorbidities that justify a risk of high mortality from causes independent of SARS-CoV-2 infection (eg, stage IV cancer)
- Patient who does not consent to participate.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Anti-SARS-CoV-2
Administration of 10 ml of a concentrated equine hyperimmune serum solution with neutralizing activity of SARS-CoV-2 not less than1/5120, administered in slow intravenous infusion (10 ml diluted in100 ml of physiological solution, administered over 50 to 60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0 when incorporated into the study -initial dose- and at 48 hours -second dose-).
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Purified F(ab')2 Fragments of Equine hyperimmune Serum with anti-SARS-CoV-2 neutralizing activity (titer 1/5120 or higher)
다른 이름들:
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위약 비교기: Placebo
Administration of 10 ml of a control-solution with no-neutralizing activity of SARS-CoV-2, administered in slow intravenous infusion (10ml diluted in 100 ml of physiological solution, administered over 50 to60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0when incorporated into the study -initial dose- and at 48 hours -second dose-).
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Administration of 10 ml of a control-solution without neutralizing activity against SARS-CoV-2, administered in slow intravenous infusion (10 ml diluted in 100 ml of saline solution, administered over 50 to 60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0 when incorporated into the study -initial dose- and at 48 hours -second dose-).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in time needed to clinical improvement
기간: Reached each day between day 1 and 28 post-inclusion in the study
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In subjects admitted to the general ward for active infection by SARS-CoV-2 and a clinical picture of pneumonia who receive supportive treatment recommended by the guidelines of the Ministry of Health of the Argentine Nation (Population), if slow intravenous administration of Anti SARS-CoV-2 in two doses 48 hours apart (Intervention) added to supportive treatment, compared to supportive treatment alone (patients will receive slow intravenous administration of a placebo solution in two doses 48 hours apart to maintain the "blind" as Comparator), changes the time needed to clinical improvement (Outcome), during 28 days after the assignment (Time).
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Reached each day between day 1 and 28 post-inclusion in the study
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in the number of patients in each World Health Organization (WHO) Ordinal Scale Category (0 to 8 being 0 better and 8 worse)
기간: days 7, 14 and 21 post-inclusion
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(a) Change in the number of patients in each World Health Organization Ordinal Scale Category (0 to 8 being 0 better and 8 worse), expecting a lower proportion of patients in categories 4, 5, 6, and 7 (OUTCOME - Efficacy);
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days 7, 14 and 21 post-inclusion
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Change in Mortality rate
기간: 28 days post-inclusion
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(b) Change of all-cause mortality at day 28 (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in Mechanical Ventilation Requirement rate
기간: 28 days post-inclusion
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(c) Determination of the frequency of invasive mechanical ventilation in the total analysis period (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in duration of oxygen treatment requirement
기간: 28 days post-inclusion
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(d) Change of the duration of oxygen therapy quantified in days of oxygen therapy (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in Length of Hospitalization
기간: 28 days post-inclusion
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(e) Change of hospital length of hospitalization, quantified in days from study inclusion until hospital discharge (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in frequency of nosocomial infection
기간: 28 days post-inclusion
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(F) Change in the frequency of patients with nosocomial infection (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in Lymphocyte cell count
기간: 28 days post-inclusion
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(g) Change of absolute lymphocyte count (OUTCOME - Efficacy);
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28 days post-inclusion
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Change in viral RNA Negativization rate on nasopharyngeal swab test
기간: 7, 14, 21, and 28 days post-inclusion
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(h) change in the proportion of patients with detected viral RNA and the viral RNA load, measured by quantitative reverse transcriptase polymerase chain reaction (RT-PCR), on day 7, 14, 21, and 28 (OUTCOME - Efficacy);
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7, 14, 21, and 28 days post-inclusion
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Description of adverse events type and frequency
기간: 28 days post-inclusion
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(i) description of reported adverse events, discriminated by their severity, and classified according to MedDRA (OUTCOME - Safety).
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28 days post-inclusion
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Requirement of additional treatments for Adverse Drug reactions
기간: 28 days post-inclusion
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(j) The number of subjects who required additional treatment as a consequence of reported adverse events in each therapeutic branch (OUTCOME - Safety)
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28 days post-inclusion
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Describe the AUC of purified F(ab')2 Anti-SARS-CoV-2
기간: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(k1) Describe area under the curve (AUC) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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Describe the Cmax of purified F(ab')2 Anti-SARS-CoV-2
기간: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(k2) Describe maximum plasma concentration (Cmax) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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Describe the t1/2 of purified F(ab')2 Anti-SARS-CoV-2
기간: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(k3) Describe plasma half life (t1/2) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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Describe the Ke of purified F(ab')2 Anti-SARS-CoV-2
기간: Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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(k4) Describe elimination constant (Ke) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients (at time Minute 0 min, hours 1, 3, 6, 24, 48, 49 and 96, day 7, 14, 21 and 28 days).
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Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Guillermo A Keller, PhD, INPB - ANLIS Malbrán
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 6월 1일
기본 완료 (예상)
2021년 11월 30일
연구 완료 (예상)
2021년 12월 31일
연구 등록 날짜
최초 제출
2021년 6월 1일
QC 기준을 충족하는 최초 제출
2021년 6월 2일
처음 게시됨 (실제)
2021년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 11일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- INPB001
- PRIISA.BA 2578 (레지스트리 식별자: PRIISA.BA)
- RENIS IS003268 (레지스트리 식별자: RENIS)
- DI-2021-2196-APN-ANMAT#MS (기타 식별자: Disposición ANMAT)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Publication of the results of all data obtained is planned.
IPD 공유 기간
After completion of the study.
IPD 공유 액세스 기준
By request to the Principal Investigator
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 정보에 입각한 동의서(ICF)
- 임상 연구 보고서(CSR)
- 분석 코드
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
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. .