Clinical Outcomes of paTients pREsenting to HArare COVID-19 CenTer of Excellence With SARS-CoV-2 Infection - (TREAT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Discharged patients
研究概览
简要总结
In order to influence COVID-19 treatment guidelines, evidence on disease progression and clinical outcomes of hospitalized COVID-19 patients, particularly those receiving innovative COVID-19 medications in an African setting is critical. This study will be conducted by EGPAF to describe patient characteristics, COVID-19 illness progression, and clinical outcomes among hospitalized COVID-19 patients at Parirenyatwa General and Harare Teaching Hospitals, COVID Centers of Excellence at in Zimbabwe.
详细描述
Rationale:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus first identified in December of 2019 in Wuhan, China. Since the first case of COVID-19 was diagnosed in 2019, the number of cases has exponentially increased globally. As of December 16th 2021, there have been over 270 million confirmed cases of COVID-19 and over 5.3 million deaths from COVID-19 across the world. Zimbabwe is one of the countries in Southern Africa affected by the COVID-19 pandemic. World Health Organization (WHO) recommended treatment with IL-6 receptor blockers for patients with severe or critical COVID-19 disease in addition to the previous recommendation of systemic corticosteroids.
Primary objectives
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To describe the clinical course and outcomes of patients admitted to the Harare Teaching Hospital - Parirenyatwa General Hospital with SARS-CoV-2 infection.
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Clinical course includes disease severity, use of oxygen, ICU admission, mechanical ventilation, treatments received, and duration of care.
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Outcomes include death, discharged or still hospitalized.
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Among discharged, outcomes will include readmission, persistent symptoms or recovery at 3 months post diagnosis.
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To determine individual-level factors associated with clinical course and disease outcome including but not limited to demographics, population (healthy adults, children, pregnant women), comorbidities (i.e. HIV, TB, diabetes, cardiovascular disease [CVD], obesity), SARS-CoV-2 vaccine status, lab/medical history, COVID-19 treatment, and disease severity at presentation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Discharged patients
时间窗: 3 months
Number of patients readmitted, experiencing persistent symptoms, recovered, as a proportion of patients admitted with COVID-19 disease
Disease severity
时间窗: 3 months
Number of patients died, discharged, or still hospitalized, as a proportion of patients admitted with COVID-19 disease
次要结局
- COVID-19 Treatment Pharmacovigilance(3 months)
