Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
Amager and Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Trials. 2020 Oct 20;21(1):867. doi: 10.1186/s13063-020-04795-0.
There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.
The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.
This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency.
ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020.
目前急需能够缩短住院时间、降低 2019 冠状病毒病患者继发感染和死亡风险的治疗方法。ProPac-COVID 试验评估了通过抗炎/免疫调节、抗病毒功效以及抢先治疗超感染，联合使用大环内酯类药物阿奇霉素和羟氯喹的治疗方案是否能缩短住院时间，并降低需要无创通气、入住重症监护病房以及因 COVID-19 疾病而死亡的风险。
ProPAC-COVID 是一项多中心、随机、安慰剂对照、双盲临床试验。主要结局是在随机分组后 14 天内存活并出院的天数。随机分组的大小未知，最终分配将根据年龄、招募地点以及患者是否有任何慢性肺部疾病进行分层。数据分析采用意向治疗（ITT）原则，主要分析还将进行修正的 ITT 分析和方案分析。
本文描述了 ProPAC-COVID 研究主要和次要结局评估的详细统计分析计划。该研究的患者入组仍在进行中。本文的目的是提供研究结果的主要出版物，以防止选择性报告结果、数据驱动的分析，并提高透明度。
ClinicalTrials.gov NCT04322396。于 2020 年 3 月 26 日注册。
