NCT05038449Unknown不适用
An IIT, Randomized, Single-Center, Open-Lable, Standard Therapy Controlled Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recovery rate of clinical symptoms (fever, cough, expectoration, chest tightness, shortness of breath, dyspnea) and virus negative conversion rate (RT-PCR) at day 7
研究概览
简要总结
This study is designed for single-center, randomized, open label, standard therapy controlled. 60 COVID-19 subjects with a treatment period of 10 days and follow-up until 28 days after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of signing ICF, the subjects were 18 to 65 years old (including 18 and 65 years old), both men and women;
- •Within 72 hours before screening, any samples confirmed by the laboratory were positive for SARS-CoV-2;
- •Clinical classification was ordinary type according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)；
- •Symptoms appeared ≤ 5 days before randomization; Such as fever, cough, shortness of breath, sore throat and diarrhea;
- •Subjects were able to communicate well with the investigator, and understand and comply with the requirements of this study, understand and sign the ICF.
排除标准
- •Severe type patients who comply with any of the following：
- •Shortness of breath, RR ≥ 30 times/min;
- •In the resting state, the oxygen saturation is less than or equal to 93%;
- •Arterial oxygen partial pressure (PaO2)/oxygen inhalation concentration (FiO2) ≤ 300 mmHg (1mmHg=0.133kPa). Note: At high altitudes (above 1000 m), PaO2/FiO2 shall be corrected according to the following formula: PaO2/FiO2 × [760/atmospheric pressure (mmHg)];
- •Pulmonary imaging shows that patients with obvious lesion progression > 50% within 24-48 hours.
- •Critical type patients who comply with any of the following：
- •Respiratory failure occurs and mechanical ventilation is required;
- •ICU monitoring and treatment are required for other organ failure.
- •People who are known to be allergic to the test drug and its components;
- •People with inflammatory bowel disease, chronic diarrhea, malabsorption;
- •People with previous neuromuscular disease;
- •People with severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2);
- •People with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum GOT or GPT 3 times higher than the normal upper limit;
- •Patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial Mediterranean fever or gout);
- •People who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening;
- •People who test positive for anti-SARS-CoV-2 immunoglobulin G (IgG);
- •People who have been vaccinated against COVID-19;
- •Any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening;
- •Suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected);
- •Suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study;
- •Pregnant or lactating women who have a positive human chorionic gonadotropin (hCG) test;
- •People who have a fertility plan or do not consent to effective non-drug contraception during the signing of the ICF to 6 months after the end of the trial;
- •Participated in other clinical studies within 30 days before screening;
- •People who have other factors that the researcher believes are not suitable for inclusion.
研究组 & 干预措施
Colchicine group
Experimental
The colchicine treatment includes an initial dose of 1 mg (1 mg and 0.5 mg two hours after), followed by 0.5 mg every 12 hours during the next 6 days and 0.5 mg every 24 hours until the completion of 10 days of total treatment.
- standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition).
干预措施: Colchicine Tablets (Drug)
Colchicine group
Experimental
The colchicine treatment includes an initial dose of 1 mg (1 mg and 0.5 mg two hours after), followed by 0.5 mg every 12 hours during the next 6 days and 0.5 mg every 24 hours until the completion of 10 days of total treatment.
- standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition).
干预措施: Standard therapy (Drug)
Standard therapy group
Placebo Comparator
Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition).
干预措施: Standard therapy (Drug)
结局指标
主要结局
Recovery rate of clinical symptoms (fever, cough, expectoration, chest tightness, shortness of breath, dyspnea) and virus negative conversion rate (RT-PCR) at day 7
时间窗: Day 7
次要结局
- Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 7(Day 7)
- Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 10(Day 10)
- Time for observation in hospital(Up to day 28)
- Changes in inflammatory markers at day 10: IL-6(Day 10)
- Changes in myocardial damage at day 7: hs-cTn(Day 7)
- Recovery rate and virus negative conversion rate (RT-PCR) of 10-day clinical symptoms (fever, cough, sputum expectoration, chest tightness, shortness of breath, dyspnea)(Day 10)
- Number of days in the intensive care unit(Up to day 28)
- Changes in inflammatory markers at day 7: IL-1β(Day 7)
- Changes in severity markers at day 10: D-dimer(Day 10)
- Changes in inflammatory markers at day 10: C-reactive protein(Day 10)
- Changes in inflammatory markers at day 7: TNF-alfa(Day 7)
- Changes in inflammatory markers at day 7: IL-6(Day 7)
- Changes in inflammatory markers at day 10: IL-1β(Day 10)
- Changes in severity markers at day 7: D-dimer(Day 7)
- Ventilator usage rate, usage time at day 10(Day 10)
- Time for the virus negative conversion (RT-PCR)(Up to day 28)
- Changes in inflammatory markers at day 7: C-reactive protein(Day 7)
- Changes in inflammatory markers at day 10: TNF-alfa(Day 10)
- Changes in myocardial damage at day 10: hs-cTn(Day 10)
- Ventilator usage rate, usage time at day 7(Day 7)
- Length of hospital stay(Up to day 28)
- Changes in myocardial damage at day 7: NT-proBNP(Day 7)
- Changes in myocardial damage at day 10: NT-proBNP(Day 10)
研究者
Hongzhou Lu
Co-Director of Shanghai Public Health Clinical Center affiliated to Fudan University
Shanghai Public Health Clinical Center
研究点 (1)
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