University of Lyon, University Claude Bernard Lyon 1, Laboratory "Systemic Health Care", EA4129, 69008, Lyon, France.
National Reference Center for Respiratory Viruses, Department of Virology, Infective Agents Institute, North Hospital Network, Lyon, France.
Trials. 2020 Nov 2;21(1):906. doi: 10.1186/s13063-020-04846-6.
OBJECTIVES: - To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals. - To compare the evolution of the SARS-CoV-2 nasal and salivary viral load according to the presence or absence of antivirals in the mouthwash. TRIAL DESIGN: This is a multi-center, randomised controlled trial (RCT) with two parallel arms (1:1 ratio). PARTICIPANTS: Inclusion criteria - Age: 18-85 years old - Clinical diagnosis of Covid-19 infection - Clinical signs have been present for less than 8 days - Virological confirmation - Understanding and acceptance of the trial - Written agreement to participate in the trial Exclusion criteria - Pregnancy, breastfeeding, inability to comply with protocol, lack of written agreement - Patients using mouthwash on a regular basis (more than once a week) - Patient at risk of infectious endocarditis - Patients unable to answer questions - Uncooperative patient The clinical trial is being conducted with the collaboration of three French hospital centers: Hospital Center Emile Roux (Le Puy en Velay, France), Clinic of the Protestant Infirmary (Lyon, France) and Intercommunal Hospital Center (Mont de Marsan, France). INTERVENTION AND COMPARATOR: Eligible participants will be allocated to one of the two study groups. Intervention group: patients perform a tri-daily mouthwash with mouthwash containing antivirals (β-cyclodextrin and Citrox®) for a period of 7 days. CONTROL GROUP: patients perform a tri-daily mouthwash with a placebo mouthwash for a period of 7 days. MAIN OUTCOMES: Primary Outcome Measures: Change from Baseline amount of SARS-CoV-2 in salivary samples at 4 and 9 hours, 1, 2, 3, 4, 5 and 6 days. Real-time PCR assays are performed to assess salivary SARS-CoV 2 viral load. SECONDARY OUTCOME MEASURES: Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 6 days. Real-time PCR assays are performed to assess nasal SARS-CoV-2 viral load. RANDOMISATION: Participants meeting all eligibility requirements are allocated to one of the two study arms (mouthwash with β-cyclodextrin and Citrox® or mouthwash without β-cyclodextrin and Citrox®) in a 1:1 ratio using simple randomisation with computer generated random numbers. BLINDING (MASKING): Participants, doctors and nurses caring for participants, laboratory technicians and investigators assessing the outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Both the intervention and control groups will be composed of 103 participants, so the study will include a total of 206 participants. TRIAL STATUS: The current protocol version is 6, August 4, 2020. Recruitment began on April 6, 2020 and is anticipated to be complete by April 5, 2021. As of October 2, 2020, forty-two participants have been included. TRIAL REGISTRATION: This trial was registered on 20 April 2020 at www.clinicaltrials.gov with the number NCT04352959 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol." The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2)."
目的:描述感染 COVID-19 的患者 SARS-CoV-2 唾液病毒载量的变化,每天进行三次含抗病毒药物的口腔冲洗,共 7 天。比较含或不含抗病毒药物的口腔冲洗对 SARS-CoV-2 鼻和唾液病毒载量的变化。
试验设计:这是一项多中心、随机对照试验(RCT),有两个平行组(1:1 比例)。
参与者:纳入标准 - 年龄:18-85 岁 - COVID-19 感染的临床诊断 - 临床症状出现不到 8 天 - 病毒学确认 - 理解并接受试验 - 书面同意参加试验 - 排除标准 - 怀孕、哺乳、无法遵守方案、缺乏书面协议 - 经常使用漱口水(每周超过一次) - 有感染性心内膜炎风险的患者 - 无法回答问题的患者 - 不合作的患者。
该临床试验由法国三个医院中心合作进行:Emile Roux 医院中心(法国 Le Puy en Velay)、新教诊所(法国里昂)和跨社区医院中心(法国 Mont de Marsan)。
干预和对照:符合条件的参与者将被分配到两个研究组之一。干预组:患者使用含抗病毒药物(β-环糊精和 Citrox®)的漱口水每天进行三次口腔冲洗,共 7 天。对照组:患者使用安慰剂漱口水每天进行三次口腔冲洗,共 7 天。
主要结局:主要结局指标:第 4 小时和第 9 小时、第 1、2、3、4、5 和 6 天唾液样本中 SARS-CoV-2 量的变化。使用实时 PCR 检测评估唾液 SARS-CoV 2 病毒载量。
次要结局:第 6 天鼻腔样本中 SARS-CoV-2 病毒量的变化。使用实时 PCR 检测评估鼻腔 SARS-CoV-2 病毒载量。
随机分组:符合所有纳入标准的参与者采用简单随机化方法,使用计算机生成的随机数按 1:1 比例分配到两个研究组之一(含β-环糊精和 Citrox®的漱口水或不含β-环糊精和 Citrox®的漱口水)。
盲法(设盲):参与者、照顾参与者的医生和护士、实验室技术人员和评估结局的研究人员将对分组情况设盲。
随机化人数(样本量):干预组和对照组各有 103 名参与者,因此该研究将包括 206 名参与者。
试验状态:目前的方案版本是 6,2020 年 8 月 4 日。招募于 2020 年 4 月 6 日开始,预计于 2021 年 4 月 5 日完成。截至 2020 年 10 月 2 日,已有 42 名参与者入组。
试验注册:该试验于 2020 年 4 月 20 日在 www.clinicaltrials.gov 上注册,编号为 NCT04352959。
完整方案:完整方案作为附加文件随附,可从试验网站获取(附加文件 1)。为了加快传播本材料,已删除熟悉的格式;本函是对完整方案主要内容的总结。“研究方案已按照标准干预临床试验推荐项目:建议(SPIRIT)指南(附加文件 2)报告。”
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