A Randomized, Placebo controlled, double blinded, parallel group clinical study to evaluate the efficacy and safety of AEV01 (Kutki) for Mild COVID19 in Elderly patients at risk of complications.

PM Medical Centre0 个研究点目标入组 70 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Willing and able to provide written informed consent prior to performing study procedures.
•2. Adult patients aged more than 50 years with SARS-CoV-2 infection and mild disease.
•Patients with Mild (uncomplicated) Illness is defined as â??
•a.Diagnosed with COVID-19 by a standardized RT-PCR assay AND
•b.Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
•c.No signs of a more serious lower airway disease AND
•d.RR <20, HR <90, oxygen saturation (pulse oximetry) > 94% on room air

•1. Participants with moderate and severe illness of COVID19.
•2. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
•3.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
•4.Immuno-compromised patients on medications.
•5.Participation in any other clinical trial of an experimental treatment for COVID-19
•6. Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment

发起方

PM Medical Centre