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临床试验/NCT05529771
NCT05529771已完成不适用

Clinical Outcomes of paTients pREsenting to HArare COVID-19 CenTer of Excellence With SARS-CoV-2 Infection - (TREAT Study)

Elizabeth Glaser Pediatric AIDS Foundation1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2022年9月22日最近更新:
适应症

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

  1. To describe the clinical course and outcomes of patients admitted to the Harare Teaching Hospital - Parirenyatwa General Hospital with SARS-CoV-2 infection.

  2. Clinical course includes disease severity, use of oxygen, ICU admission, mechanical ventilation, treatments received, and duration of care.

  3. Outcomes include death, discharged or still hospitalized.

  4. Among discharged, outcomes will include readmission, persistent symptoms or recovery at 3 months post diagnosis.

  5. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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