ISRCTN85874083进行中（未招募）未知
Cotrimoxazole in hospitalised patients with severe COVID-19 infection compared to the standard of care – an investigator-initiated, randomised controlled trial
School of Tropical Medicine, Kolkata0 个研究点目标入组 110 人开始时间: 2021年2月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/11/2022:
- •1. Adult male or female individuals, age =18 years and =70 years
- •2. Patients giving written informed consent to participate in the study (i.e. GCS 15/15: conscious, alert, and oriented)
- •3. COVID-19 documented by a positive RT-PCR test/Rapid Antigen Test
- •4. Hospitalised patients with severe COVID-19, requiring supplemental oxygen through a non-re-Breath mask between 10-15 l/min maintaining saturations between 92-96% for up to 30 h and between 94-98% for the first 6 h
- •5. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional)
- •Previous inclusion criteria as of 13/05/2021:
- •1. Adult male or female individuals, age =18 years and =65 years
- •2. Patients giving written informed consent to participate in the study (i.e. GCS 15/15: conscious, alert, and oriented)
- •3. COVID-19 documented by a positive RT-PCR test/Rapid Antigen Test
- •4. Hospitalised patients with severe COVID-19, requiring supplemental oxygen through a non-re-Breath mask between 10-15 l/min maintaining saturations between 92-96% for up to 30 h and between 94-98% for the first 6 h
- •5. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional)
- •Previous inclusion criteria:
- •1. Aged between 18 and 65 years
- •2. COVID-19 infection documented by a positive RT-PCR test
- •3. Hospitalised with severe COVID-19 infection, characterized by fever (at the time of screening or when admitted) and requiring supplemental oxygen through non-rebreather mask between 10 and 15 l/ min
- •4. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional)
- •5. Informed written consent given
排除标准
- •Current exclusion criteria as of 13/05/2021:
- •1. Patients who require invasive or non-invasive (including CPAP and high flow nasal cannula). ventilation at the time of inclusion
- •2. AST/ALT values >5 fold the upper normal limit
- •3. Impairment of renal function( creatinine clearance<30ml/min/m²)
- •4. Absolute neutrophil count below 500 cells/mm³
- •5. Absolute platelet count below 50,000 cells/mm³
- •6. Documented sepsis or high clinical suspicion of superimposed severe bacterial or fungal infection
- •7. Concomitant acute medical emergencies, such as AMI, acute pericarditis, PE, stroke, acute Surgical and orthopaedic emergencies like acute abdomen and fractured neck of femur etc.
- •8. Comobidities or concomitant medications likely to be incompatible for cotrimoxazole use pregnancy or lactation
- •9. History of cotrimoxazole hypersensitivity
- •10. Patients participating in another clinical trial for SARS-CoV-2 infection
- •Previous exclusion criteria:
- •1. Require invasive or non-invasive (including CPAP and high flow nasal cannula) ventilation at the time of inclusion
- •2. Aspartate transaminase (AST)/alanine transaminase (ALT) ratio >5 times the ULN
- •3. Documented impairment of renal function
- •4. Absolute neutrophil count <500 cells/mm³
- •5. Absolute platelet count <50,000 cells/mm³
- •6. Documented sepsis or high suspicion of superimposed severe bacterial or fungal infection
- •7. Comorbidities or concomitant medications likely to be incompatible for cotrimoxazole use
- •8. Pregnancy or lactation
- •9. History of cotrimoxazole hypersensitivity
- •10. Participating in another clinical trial for SARS-CoV-2 infection
研究者
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