CTRI/2020/10/028297尚未招募2 期
Cotrimoxazole in hospitalised patients with moderate to early-severe COVID-19 infection compared to the standard of care â?? an investigator-initiated, randomised controlled trial (CoTroxCov Study)
Dept of Health and Family Welfare Government of West Bengal0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a. Adult individuals, age >18 and <65 years
- •b. COVID-19 infection documented by a positive RT-PCR test
- •c. Hospitalised patients with moderate to early-severe COVID-19 infection, characterized by
- •fever (at the time of screening or when admitted), oxygen saturation <= 94% on air at rest and requiring supplemental oxygen through mask or nasal cannula/catheter
- •d. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional)
- •e. Informed verbal consent under urgent conditions, documented in the electronically
排除标准
- •a. Patients who require invasive or non-invasive (including CPAP and high flow nasal cannula) ventilation at the time of inclusion.
- •b. AST/ALT values >5 fold the ULN.
- •c. Documented impairment of renal function
- •d. Absolute neutrophil count below 500 cells/mm3
- •e. Absolute platelet count below 50,000 cells/mm3
- •f. Documented sepsis or high suspicion of superimposed severe bacterial or fungal infection
- •g. Comorbidities or concomitant medications likely to be incompatible for cotrimoxazole use
- •h. Pregnancy or lactation.
- •i. History of cotrimoxazole hypersensitivity
- •j. Patients participating in another clinical trial for SARS-CoV-2 infection
研究者
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