PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V).
PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V).
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作者：
尽管引入了疫苗接种，但仍然需要接触前预防SARS-CoV-2的药物。由于潜在的健康状况、接受的治疗或疫苗接种反应不佳，一些患者群体更容易受到SARS-CoV-2感染。PROTECT-V是一个平台试验，测试暴露前预防干预措施对脆弱的患者群体(器官移植接受者、有肿瘤/血液学诊断、需要免疫抑制或透析的免疫缺陷或自身免疫疾病)的SARS-CoV-2感染的干预作用。可以在共享安慰剂组的多个脆弱人群中评估多种药物，并可以选择在稍后的时间点添加额外的治疗方法。主要终点是有症状的SARS-CoV-2感染，当所需数量的事件发生时，每个病原体都将得到独立的实时评估。目前，该平台批准了三种药物：鼻用氯硝柳胺、鼻腔和吸入环索奈德以及静脉注射索维玛。尽管引入了疫苗接种，但仍然需要接触前预防SARS-CoV-2的药物。由于潜在的健康状况、接受的治疗或对疫苗的次佳反应，一些患者群体更容易患上新冠肺炎病。临床试验.gov NCT04870333。EudraCT2020-004144-28
Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to SARS-CoV-2 infection by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. PROTECT-V is a platform trial testing pre-exposure prophylactic interventions against SARS-CoV-2 infection in vulnerable patient populations (organ transplant recipients; individuals with oncological/haematological diagnoses, immune deficiency or autoimmune diseases requiring immunosuppression or on dialysis). Multiple agents can be evaluated across multiple vulnerable populations sharing placebo groups, with the option of adding additional treatments at later time points as these become available. The primary endpoint is symptomatic SARS-CoV-2 infection, and each agent will be independently evaluated in real time when the required number of events occurs. Presently, three agents are approved in the platform: intranasal niclosamide, nasal and inhaled ciclesonide and intravenous sotrovimab. Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to COVID-19 disease by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. ClinicalTrials.gov NCT04870333. EudraCT 2020-004144-28
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DOI：
10.1084/jem.20020400
发表时间：
2002-08-05
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
Spiekermann GM;Finn PW;Ward ES;Dumont J;Dickinson BL;Blumberg RS;Lencer WI
通讯作者：
Lencer WI
影响因子：
12.4
作者：
Pedersen, W;Hjuler, I;Mygind, N
通讯作者：
Mygind, N
影响因子：
4.7
作者：
Pindiprolu, Sai Kiran S. S.;Pindiprolu, Sai Harshini
通讯作者：
Pindiprolu, Sai Harshini
影响因子：
5.9
作者：
Chervinsky, Paul;Kunjibettu, Sudeesha;Shah, Tushar
通讯作者：
Shah, Tushar
DOI：
10.1164/rccm.202003-0821oc
发表时间：
2020-07-01
影响因子：
24.7
作者：
Peters, Michael C.;Sajuthi, Satria;Fahy, John, V
通讯作者：
Fahy, John, V