A Randomized Clinical Trial Testing Hydroxychloroquine for Reduction of SARS-CoV-2 Viral Shedding and Hospitalization in Early Outpatient COVID-19 Infection.
A Randomized Clinical Trial Testing Hydroxychloroquine for Reduction of SARS-CoV-2 Viral Shedding and Hospitalization in Early Outpatient COVID-19 Infection.
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DOI：
10.1128/spectrum.04674-22
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发表时间：
2023-03-02
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
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作者：
在2019冠状病毒病大流行早期，没有有效的治疗方法来防止最近确诊的门诊患者的2019冠状病毒病临床恶化。在犹他州湖城的犹他州大学，我们进行了一项2期前瞻性平行组随机安慰剂对照试验（NCT 04342169），以确定在疾病早期给予羟氯喹是否减少SARS-CoV-2脱落的持续时间。我们招募了近期SARS-CoV-2诊断检测阳性（入组后72小时内）的非住院成人（≥18岁）和成人家庭接触者。受试者在第1天口服400 mg羟氯喹，每日两次，然后在第2 - 5天口服200 mg羟氯喹，每日两次，或按照相同的时间表口服安慰剂。我们在第1天至第14天和第28天对口咽拭子进行了SARS-CoV-2核酸扩增检测（NAAT），并监测了成人家庭接触者的临床表现、住院率和病毒感染情况。我们发现，在SARS-CoV-2的口咽携带持续时间方面没有总体差异（羟氯喹与安慰剂相比的病毒脱落时间风险比为1.21; 95%置信区间[CI]为0.91，1.62）。总体而言，两种治疗的28天住院率相似（羟氯喹组为4.6%，安慰剂组为2.7%）。治疗组之间在症状持续时间、严重程度或家庭接触者中的病毒获得方面没有差异。该研究未能达到预先设定的入组目标，这可能是受到2021年春季首次疫苗推广对应的COVID-19发病率急剧下降的影响。口咽拭子是自行采集的，这可能会导致这些结果的变异性。安慰剂治疗与羟氯喹治疗不同（胶囊与片剂），这可能导致受试者意外揭盲。在COVID-19大流行早期的这组社区成年人中，羟氯喹并没有显著改变早期COVID-19疾病的自然史。(This该研究已在ClinicalTrials.gov注册，注册号为NCT 04342169）。重要性在2019冠状病毒病大流行早期，没有有效的治疗方法来防止最近确诊的门诊患者的2019冠状病毒病临床恶化。羟氯喹作为一种可能的早期治疗方法受到关注;然而，缺乏高质量的前瞻性研究。我们进行了一项临床试验，以测试羟氯喹预防COVID-19临床恶化的能力。
Early in the COVID-19 pandemic, no effective treatment existed to prevent clinical worsening of COVID-19 among recently diagnosed outpatients. At the University of Utah, Salt Lake City, Utah, we conducted a phase 2 prospective parallel group randomized placebo-controlled trial (NCT04342169) to determine whether hydroxychloroquine given early in disease reduces the duration of SARS-CoV-2 shedding. We enrolled nonhospitalized adults (≥18 years of age) with a recent positive diagnostic test for SARS-CoV-2 (within 72 h of enrollment) and adult household contacts. Participants received either 400 mg hydroxychloroquine by mouth twice daily on day 1 followed by 200 mg by mouth twice daily on days 2 to 5 or oral placebo with the same schedule. We performed SARS-CoV-2 nucleic acid amplification testing (NAAT) on oropharyngeal swabs on days 1 to 14 and 28 and monitored clinical symptomatology, rates of hospitalization, and viral acquisition by adult household contacts. We identified no overall differences in the duration of oropharyngeal carriage of SARS-CoV-2 (hazard ratio of viral shedding time comparing hydroxychloroquine to placebo, 1.21; 95% confidence interval [CI], 0.91, 1.62). Overall, 28-day hospitalization incidence was similar between treatments (4.6% hydroxychloroquine versus 2.7% placebo). No differences were seen in symptom duration, severity, or viral acquisition in household contacts between treatment groups. The study did not reach the prespecified enrollment target, which was likely influenced by a steep decline in COVID-19 incidence corresponding to the initial vaccine rollout in the spring of 2021. Oropharyngeal swabs were self-collected, which may introduce variability in these results. Placebo treatments were not identical to hydroxychloroquine treatments (capsules versus tablets) which may have led to inadvertent participant unblinding. In this group of community adults early in the COVID-19 pandemic, hydroxychloroquine did not significantly alter the natural history of early COVID-19 disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT04342169). IMPORTANCE Early in the COVID-19 pandemic, no effective treatment existed to prevent clinical worsening of COVID-19 among recently diagnosed outpatients. Hydroxychloroquine received attention as a possible early treatment; however, quality prospective studies were lacking. We conducted a clinical trial to test the ability of hydroxychloroquine to prevent clinical worsening of COVID-19.
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影响因子：
39.2
作者：
Skipper, Caleb P.;Pastick, Katelyn A.;Boulware, David R.
通讯作者：
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作者：
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DOI：
10.9778/cmajo.20210069
发表时间：
2021-04
期刊：
CMAJ open
影响因子：
--
作者：
Schwartz I;Boesen ME;Cerchiaro G;Doram C;Edwards BD;Ganesh A;Greenfield J;Jamieson S;Karnik V;Kenney C;Lim R;Menon BK;Mponponsuo K;Rathwell S;Ryckborst KJ;Stewart B;Yaskina M;Metz L;Richer L;Hill MD;ALBERTA HOPE COVID-19 Collaborators
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ALBERTA HOPE COVID-19 Collaborators
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影响因子：
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作者：
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