PACTR202010519682638尚未招募3 期
Hydroxychloroquine/Azithromycin/Zinc Combination and Hydroxychloroquine/Lopinavir/Ritonavir/Azithromycin/Zinc combination versus the standard of care in The Treatment of Hospitalized COVID-19 Patients
ational Institute for Pharmaceutical Research and Development NIPRD0 个研究点目标入组 210 人开始时间: 2020年6月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •. Hospitalized patients with PCR- documented SARS-CoV-2 RNA from throat /nasopharyngeal swab, samples
- •2. Aged between 18-80 years old
- •3. the weight is more than 30kg, and there is no limit for men and women
- •4. Patients who meet the following conditions: creatinine = 110 umol / L, creatinine clearance rate (EGFR) = 60 ml / min / 1.73m2,
- •5. AST and ALT = 5 × ULN
- •6. TBIL = 2 × ULN;
- •7. Patients who are able to fully understand the purpose, nature, method of the study and the possible reactions to the study drugs, voluntarily participate in the study and sign the informed consent
- •8. Not having severe acute respiratory syndrome (SARS)
- •9. Patients not using mechanical ventilation or supplemental oxygen, with peripheral oxygen saturation >94% in room air, and having a respiratory rate below 24 incursions per minute.
- •6. A Normal ECG Baseline result which remains same throughout the study.
排除标准
- •1.Hypersensitivity reaction to chloroquine, 4-aminoquinolines or azithromycin and ivermectin
- •2.Shortness of breath in resting position
- •3. Known prolonged QT syndrome
- •4. Active or clinically significant cardiac disease including congestive heart failure.
- •5. History or current evidence of clinically significant cardiac arrhythmia, atrial fibrillation or paroxysmal supraventricular tachycardia
- •6. Use of concomitant medications that prolong the QT/QTc interval
- •7. Elevated levels of troponin I, Creatinine kinase MB, and Myoglobin
- •8. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •9. Already receiving chloroquine or azithromycin
- •10. Patients with other viral pneumonia
- •11. Patients who have received organ transplantation or surgery planning in the past 6 months
- •12. Patients who can't take food or drugs due to coma or intestinal obstruction
- •13. Patients who have severe underlying diseases that affect survival including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding and severe malnutrition
- •14. Patients that are pregnant or lactating
- •15. Patients (including male Patients) having a pregnancy plan (including plans for sperm donation or egg donation)
- •16. Patients that may fail to take effective contraceptive measures within the next 6 months
- •17. Patients with allergies to macrolides and chloroquine tablets
- •18. Patients with contraindications to the test drugs.
- •19. Patients who are using drugs that interact with the test drugs.
- •20. Patients using drugs associated with severe and/or life-threatening events [with a narrow therapeutic index]
- •21. Patients with cirrhosis or pancreatitis
- •22. Patients with Creatinine QUOTE >110 umol/l
- •23. Patients with decreased liver function
- •24. Patients who in the opinion of the investigators after assessing all relevant parameters are unsuitable for the study.
研究者
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