A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non-critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline.

niversity College Dublin0 个研究点目标入组 267 人开始时间: 2020年4月7日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•Documented Covid-19 positive
•Evidence of progressive clinical decline:
•oRising inflammatory markers over a 24 hour period (increases in CRP, d-dimer, LDH and/or ferritin above the upper limit of normal)
•oPresence of or progression of pulmonary infiltrates on CXR (as decided by the treating physician)
•oNew hypoxia requiring >2l/min/28% FiO2 to maintain oxygen saturations =94% (or 88-92% in patients with chronic hypercapnic respiratory failure)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 161
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 106

•Pregnant or breastfeeding woman
•Known hypersensitivity to chloroquine or hydroxy chloroquine or any excipients
•Known hypersensitivity to azithromycin, erythromycin or any of the macrolide or ketolide antibiotics or any of the excipients
•Known deficit in G6PD
•Known retinopathy
•Patient with history of cardiac arrythmia related to QT prolongation
•Suspected acute cardiogenic pulmonary oedema at the time of enrolment
•QTc >500ms on two consecutive ECG measurements at screening
•Hypokalaemia (<3.0mmol/L) or hyperkalaemia (>6.1mmol/L) at screening
•Hypocalcaemia (<2.1mmol/L) or hypercalcaemia (>2.6mmol/L) (corrected for albumin) at screening
•Subjects receiving medications with a significant QT prolongation potential (if these treatments cannot be discontinued)

发起方

niversity College Dublin