Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-01-25 DOI:10.1016/j.vaccine.2024.126582

Kerry Conlin , Daniel Jenkin , Philip de Whalley , Lily Yin Weckx , Pedro M. Folegatti , Sagida Bibi , Teresa Lambe , Parvinder K. Aley , Andrew J. Pollard , Merryn Voysey , Sue Ann Costa Clemens , COV003 Study Group

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引用次数: 0

Abstract

Objectives

To identify demographic, clinical and immunological factors associated with adverse COVID-19 outcomes.

Methods

A large randomised controlled trial of ChAdOx1 nCoV-19 was undertaken in Brazil. Participants were randomised 1:1 either to receive ChAdOx1 nCov-19 or to a control group. COVID-19 infections were confirmed by nucleic acid amplification test (NAAT) and classified using the WHO clinical progression scale. Anti-spike antibody responses and serum neutralising activity were measured 28 days after second vaccination in some participants. Exploratory analyses were conducted into factors associated with COVID-19 infection severity and hospitalisation, using logistic regression models adjusted for demographic and clinical factors.

Results

10,416 participants were enrolled; 1790 had NAAT-positive COVID-19 infection; 63 cases required hospitalisation. More severe infection was associated with greater body-mass index (BMI) (odds ratio [OR] = 1.06 [95 %CI: 1.01–1.10], p = 0.01) and diabetes (OR = 3.67 [1.59–8.07], p = 0.003). Hospitalisation risk increased with greater age (OR = 1.06 [1.03–1.08], p < 0.001) and BMI (OR = 1.10 [1.05–1.16], p < 0.001). More severe infection and hospitalisation risks increased >180 days after last vaccination. In the fully vaccinated subgroup (n = 841), only greater age predicted hospitalisation (OR = 1.07 [1.03–1.12], p < 0.001). Serological responses to two vaccine doses diminished with age.

Conclusions

Unvaccinated individuals with high BMI and diabetes risked more severe COVID-19 outcomes. Vaccination mitigated this risk.

Clinical Trial Registration Number: NCT04536051

查看原文本刊更多论文

巴西 SARS-CoV-2 感染严重程度的预测因素：随机对照试验的事后分析。

目的：确定与 COVID-19 不良后果相关的人口统计学、临床和免疫学因素：确定与 COVID-19 不良结局相关的人口、临床和免疫学因素：在巴西开展了一项关于 ChAdOx1 nCoV-19 的大型随机对照试验。参与者按 1:1 的比例被随机分配到接受 ChAdOx1 nCov-19 或对照组。COVID-19感染通过核酸扩增试验（NAAT）确认，并采用世界卫生组织临床进展量表进行分类。部分参与者在第二次接种后 28 天测量了抗尖峰抗体反应和血清中和活性。利用调整了人口统计学和临床因素的逻辑回归模型，对与 COVID-19 感染严重程度和住院治疗相关的因素进行了探索性分析：结果：10416 名参与者参与了研究，其中 1790 人感染了 NAAT 阳性的 COVID-19，63 人需要住院治疗。更严重的感染与更高的体重指数（BMI）（比值比 [OR] = 1.06 [95 %CI: 1.01-1.10]，p = 0.01）和糖尿病（OR = 3.67 [1.59-8.07]，p = 0.003）有关。年龄越大，住院风险越高（OR = 1.06 [1.03-1.08]，p 最后一次接种疫苗后 180 天。在完全接种疫苗的亚组（n = 841）中，只有年龄越大，住院风险越高（OR = 1.07 [1.03-1.12]，p 结论：在完全接种疫苗的亚组（n = 841）中，只有年龄越大，住院风险越高：未接种疫苗的高体重指数和糖尿病患者面临更严重的 COVID-19 后果风险。临床试验注册号：NCT04536051：临床试验注册号：NCT04536051。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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