Abstract

Background:

The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries.

Objective:

To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes.

Methods:

We describe participants’ clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period.

Results:

A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19.

Discussion:

The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.

中文翻译：

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在COVID-19危机期间管理阿尔茨海默氏病的临床试验：西班牙巴塞罗那FundacióACE的经验

摘要

背景：

COVID-19大流行给全世界的卫生系统带来了极大的破坏。这影响了正在进行的临床研究，特别是在那些最容易受到大流行影响的人群中，例如痴呆症患者。FundacióACE是一家研究中心和记忆诊所，总部位于西班牙受灾最严重的国家之一的巴塞罗那。

目的：

描述为应对这场危机并分享其成果而制定的临时战略计划。

方法：

我们描述参与者的临床和人口统计学特征。此外，我们向所有参与者和人员解释了旨在最大程度地减少对临床试验研究活动的影响的战略计划，其中包括SARS-CoV-2 RT-PCR和IgG血清学测试。根据研究期间观察到的安全事件和辍学来描述计划的结果。

结果：

建立封锁后，共有130名患者参加了FundacióACE的16项积极临床试验。在分娩过程中，我们对参与者进行了1018次呼叫，从而确定了26例不良事件和6例COVID-19症状。总共有83位患者（64％）最早可以在2020年5月11日重新开始现场访问在现场探访之前进行的所有SARS-CoV-2 RT-PCR诊断测试均为阴性，只有3项IgG血清学测试均为阳性。在整个研究期间，由于与COVID-19无关的不良事件，我们仅观察到一个退出。

讨论：

FundacióACE实施的计划能够保持正在进行的临床试验的安全性和完整性。我们必须将从大流行和设计抗危机协议中汲取的教训用于临床试验。