CTRI/2020/06/025957已完成3 期
A Randomized Open-Label Study To Evaluate The Efficacy And Safety Of Favipiravir And Umifenovir As Compared To Favipiravir Alone In Moderate Hospitalized Adult Indian COVID-19 Patients.
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 158 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
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
- •Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures
- •2. Age > 18 years at the time of signing ICF
- •3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization)
- •4. Radiographic evidence of pneumonia
- •5. Respiratory rate > 24 breaths per minute
- •6. Any two of the following signs or symptoms suggestive of COVID-19: cough/shortness of breath or difficulty in breathing/fever/chills/muscle pain/sore throat/new loss of taste or smell
- •7. Oxygen saturation (SpO2) <= 93 % on room air
- •8. Time interval between symptoms onset and randomization less than 10 days
- •9. Currently hospitalized and requiring medical care for COVID 19
- •10. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum pregnancy test
- •11. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment;
- •12. Not participating in any other interventional drug clinical studies before completion of the present study.
排除标准
- •Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
- •Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.
- •Severe respiratory distress and PaO2/FiO2 <= 300 mmHg
- •Inability to intake or tolerate oral medications.
- •Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN
- •Gout/history of gout or hyperuricemia (above the ULN)
- •Prolonged QT, defined as QTcF >=450 milliseconds for men and as QTcF >=470 for women
- •Known severely reduced LV function (ejection fraction <30%)
- •Heart rate >= 125 beats per minute
- •Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure).
- •Known allergy or hypersensitivity to favipiravir or umifenovir
- •Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers
- •Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
- •Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
- •Asthma or chronic obstructive lung disease
- •Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year).
- •Pregnant or lactating women;
- •Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.
- •Clinical prognostic non-survival or requirement of palliative care.
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