Randomized clinical trial, phase 3, to evaluate the efficacy of CVO + versus placebo for the treatment of COVID-19.

PHARAMALAGASY0 个研究点目标入组 338 人开始时间: 2021年3月19日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Study participant (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
•Understands and agrees to comply with planned study procedures.
•Agrees to the collection of OP swabs and venous blood per protocol.
•Male or non-pregnant female adult =18 years of age at time of enrolment.
•Laboratory-confirmed SARS-CoV-2 infection as determined by PCR nasopharyngeal swab.
•Illness of any duration, and at least one of the follow ing:
•Clinical assessment (evidence of rales/crackles on exam) or
•Requiring mechanical ventilation and/or supplemental oxygen.
•Creatinine = 110 umol/L, creatinine clearance rate (EGFR) = 60 ml / min / 1.73m2, AST and ALT = 5 × ULN, TBIL = 2 × ULN;
•A Normal ECG Baseline result, which is maintained throughout the study.

•ALT/AST > 5 times the upper limit of normal.
•Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
•Pregnancy or breast feeding.
•Anticipated transfer to another hospital w hich is not a study site w ithin 72 hours.
•Allergy to any study medication
•Shortness of breath in resting position
•Known prolonged QT syndrome
•Use of concomitant medications that prolong the QT/QTc interval
•Participant with other viral pneumonia
•Participants with allergies to artemisinin containing products
•History of allergic reactions to any investigational medical product ingredient

发起方

PHARAMALAGASY