Phase 3, Randomized, Double-blind, Placebo control trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients.

Director CSIR Central Drug Research Institute0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Asymptomatic persons WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens.
•2. Case categories as uncomplicated illness, Mild pneumonia, Moderate pneumonia according to severity WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens as per Ministry of health & Family welfare, Govt of India guidelines. Patients with uncomplicated upper respiratory tract viral infection may have non-specific symptoms such as fever, cough, expectoration, shortness of breath, myalgia, fatigue, sore throat, nasal congestion, diarrhea, loss of taste WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens.
•Mild pneumonia WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. Moderate pneumonia is defined as Adults with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute.
•3. 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.
•4. Not participating in any other interventional drug clinical studies before completion of the present study.

•Severe COVID-19, as defined in Ministry of Health, Govt of India guidelines. Adolescent or adult: fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air, Cases of Acute respiratory distress syndrome (ARDS).
•Sepsis, Septic shock as defined in MOH&FW guidelines. The cases as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. Inability to intake or tolerate oral medications.
•oKnown allergy or hypersensitivity to Umifenovir
•oPossibility of the subject being transferred to a non-study hospital within 72h
•oPregnant or lactating women
•oSevere liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN;
•oKnown severe renal impairment [creatinine clearance (CcCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
•O Known disease or comorbid condition like asthma, diabetes with second-and third-line medicines, insulin as defined in WHO guidance document.18
•OThe disease or condition which may affect the study as decided by physician.

发起方

Director CSIR Central Drug Research Institute