PACTR202007720062393尚未招募2 期
Combination Therapies to Reduce the Nasopharyngeal Carriage of SARS-CoV-2 and Improve the Outcome of COVID-19 Infection in Ivory Coast (INTENSE-COV): a Phase IIb Randomized Clinical Trial
Inserm ANRS0 个研究点目标入组 294 人开始时间: 2020年7月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 294
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
- •Patients over 18 years of age.
- •- With SARS-CoV-2 infection confirmed by specific PCR.
- •- With clinical manifestations of the infection, such as fever or cough, or otolaryngologic (ORL) signs or respiratory difficulties, that started less than 7 days ago.
- •- COVID-19 specific treatment-naive.
- •- Women of childbearing age should accept the use of mechanical contraception during the study period.
- •- Informed consent signed by the patient.
排除标准
- •- Severe form of infection requiring oxygen therapy > 4l/min to achieve oxygen saturation > 94%.
- •- Patient whose weight is < 35kg.
- •- Pharmacological investigation contraindicating the introduction of a CYP450 inhibitor, in particular the CYP3A4 isoform.
- •- Known hypersensitivity to lopinavir, ritonavir, telmisartan, atorvastatin or their excipients.
- •- Renal impairment (eGFR <30 mL/min, CKD-EPI formulation).
- •- Known cirrhosis.
- •- Transaminases > 3N.
- •- Bilirubin > 2.6N.
- •- Electrocardiogram showing QTc> 500 ms.
- •- HIV-infected patient without treatment or treated with protease inhibitors (lopinavir, darunavir, atazanavir).
- •- Ongoing exposure to statins.
- •- Contraindications to the use of statin (CPK > 5N, history of rhabdomyolysis or myopathies, increased risk when atorvastatin is administered with strong CYP3A4 inhibitors or transport proteins (cyclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir, erythromycin, diltiazem, verapamil, fluconazole)).
- •- Ongoing exposure to sartans.
- •- Contraindications to the use of telmisartan (patient on angiotensin-converting enzyme (ACE) inhibitors, aliskiren or other angiotensin receptor blockers (ARB)).
- •- Curatorship or guardianship.
- •- Pregnancy or breastfeeding.
- •- Dementia or any other condition that prevents informed consent.
- •- Any reason that, at the discretion of the investigator, would compromise patient safety and cooperation in the trial.
研究者
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