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Safety and Effectiveness of an Immunobiological Drug in CoViD-19 (INPB001)

2021年9月11日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

200

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 阿根廷
      • Ciudad Autónoma De Buenos Aires、阿根廷、1408
        • 招聘中
        • Hospital General de Agudos Donación Francisco J. Santojanni
        • 接触：
        • 接触：
        • 首席研究员：
          • Guillermo A Keller, MD PhD
        • 副研究员：
          • Guillermo Di Girolamo, MD PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Subjects over 18 years old and under 80 years old.
  2. Positive results by RT-PCR for SARS CoV-2
  3. 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.
  4. Patient with good disposition towards the study and that signs the informed consent.

Exclusion Criteria:

  1. 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%)
  2. Patients with clinical disease corresponding to severe forms (Severe pneumonia: presence of severity criteria (ATS / IDSA), one of two major or three minor criteria.)
  3. 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.
  4. Pregnant or lactating women.
  5. Women of childbearing potential not using an effective contraceptive method (withdrawal, intrauterine device, or oral contraceptives).
  6. History of severe anaphylactic reaction with the administration of equine plasma.
  7. Patients with comorbidities that justify a risk of high mortality from causes independent of SARS-CoV-2 infection (eg, stage IV cancer)
  8. Patient who does not consent to participate.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：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-).
药品：Anti-SARS-CoV-2
Purified F(ab')2 Fragments of Equine hyperimmune Serum with anti-SARS-CoV-2 neutralizing activity (titer 1/5120 or higher)
其他名称：
  • 治疗组
  • Purified F(ab')2 Fragments of Equine hyperimmune Serum
  • F(ab')2 Fragments
  • Passive Immunotherapy
  • Equine F(ab')2 Fragments
  • Hyperimmune Equine Serum
安慰剂比较：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-).
药品：Placebo
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-).
其他名称：
  • 控制组

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in time needed to clinical improvement
大体时间：Reached each day between day 1 and 28 post-inclusion in the study
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).
Reached each day between day 1 and 28 post-inclusion in the study

次要结果测量

结果测量
措施说明
大体时间
Change in the number of patients in each World Health Organization (WHO) Ordinal Scale Category (0 to 8 being 0 better and 8 worse)
大体时间：days 7, 14 and 21 post-inclusion
(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);
days 7, 14 and 21 post-inclusion
Change in Mortality rate
大体时间：28 days post-inclusion
(b) Change of all-cause mortality at day 28 (OUTCOME - Efficacy);
28 days post-inclusion
Change in Mechanical Ventilation Requirement rate
大体时间：28 days post-inclusion
(c) Determination of the frequency of invasive mechanical ventilation in the total analysis period (OUTCOME - Efficacy);
28 days post-inclusion
Change in duration of oxygen treatment requirement
大体时间：28 days post-inclusion
(d) Change of the duration of oxygen therapy quantified in days of oxygen therapy (OUTCOME - Efficacy);
28 days post-inclusion
Change in Length of Hospitalization
大体时间：28 days post-inclusion
(e) Change of hospital length of hospitalization, quantified in days from study inclusion until hospital discharge (OUTCOME - Efficacy);
28 days post-inclusion
Change in frequency of nosocomial infection
大体时间：28 days post-inclusion
(F) Change in the frequency of patients with nosocomial infection (OUTCOME - Efficacy);
28 days post-inclusion
Change in Lymphocyte cell count
大体时间：28 days post-inclusion
(g) Change of absolute lymphocyte count (OUTCOME - Efficacy);
28 days post-inclusion
Change in viral RNA Negativization rate on nasopharyngeal swab test
大体时间：7, 14, 21, and 28 days post-inclusion
(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);
7, 14, 21, and 28 days post-inclusion
Description of adverse events type and frequency
大体时间：28 days post-inclusion
(i) description of reported adverse events, discriminated by their severity, and classified according to MedDRA (OUTCOME - Safety).
28 days post-inclusion
Requirement of additional treatments for Adverse Drug reactions
大体时间：28 days post-inclusion
(j) The number of subjects who required additional treatment as a consequence of reported adverse events in each therapeutic branch (OUTCOME - Safety)
28 days post-inclusion
Describe the AUC of purified F(ab')2 Anti-SARS-CoV-2
大体时间：Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
(k1) Describe area under the curve (AUC) of the active drug, based on concentrations determined in plasma samples obtained from the first 20 patients
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
Describe the Cmax of purified F(ab')2 Anti-SARS-CoV-2
大体时间：Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
(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).
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
Describe the t1/2 of purified F(ab')2 Anti-SARS-CoV-2
大体时间：Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
(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).
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
Describe the Ke of purified F(ab')2 Anti-SARS-CoV-2
大体时间：Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days
(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).
Time 0 (Basal, prior to drug administration), hours 1, 3, 6, 24, 48, 49 and 96, days 7, 14, 21 and 28 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran

调查人员

  • 首席研究员：Guillermo A Keller, PhD、INPB - ANLIS Malbrán

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月1日

初级完成 (预期的)

2021年11月30日

研究完成 (预期的)

2021年12月31日

研究注册日期

首次提交

2021年6月1日

首先提交符合 QC 标准的

2021年6月2日

首次发布 (实际的)

2021年6月4日

研究记录更新

最后更新发布 (实际的)

2021年9月17日

上次提交的符合 QC 标准的更新

2021年9月11日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • INPB001
  • PRIISA.BA 2578 (注册表标识符：PRIISA.BA)
  • RENIS IS003268 (注册表标识符：RENIS)
  • DI-2021-2196-APN-ANMAT#MS (其他标识符：Disposición ANMAT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Publication of the results of all data obtained is planned.

IPD 共享时间框架

After completion of the study.

IPD 共享访问标准

By request to the Principal Investigator

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 知情同意书 (ICF)
  • 临床研究报告（CSR）
  • 解析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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