Randomised Controlled Trial to compare efficacy of hydroxychloroquine alone and in combination with azithromycin in treatment of COVID-19 - HAZES

Director General Armed Forces Medical Services0 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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•Age > 18 years
•Case definitions for inclusion in the study will include mild, moderately severe and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020.
•Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI)
•Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%).
•Severe: Severe Pneumonia (with respiratory rate >=30/minute and/or SpO2 < 90% in room air) or ARDS or septic shock
•Laboratory confirmed SARS CoV-2 infection within last 10d or SARS CoV-2 test result pending with a high clinical suspicion as defined by:
•Cough of <10d duration
•Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air
•No alternative explanation for respiratory symptoms
•Scheduled for admission or enrolled within 48h of hospital admission

•Children < 18 years
•Pregnant or lactating women
•Symptoms of acute respiratory tract infection for > 10d before randomisation
•More than 48h have elapsed between meeting inclusion criteria and randomisation
•Seizure disorder
•Known case of G6PD deficiency
•Diagnosed long QT syndrome
•QTc >500ms on ECG within 72h prior to enrolment
•Chronic haemodialysis or GFR <20 ml/min
•Psoriasis or porphyria cutanea tarda
•Severe liver disease
•Any subject who has received the following drugs in the 12h period before enrolment or who is likely to receive the following during the period of therapy with HCQ / HCQ + AZT / AZT: amiodarone, cimetidine, phenobarbitone, phenytoin, digoxin
•Receipt of >1 dose of HCQ / AZT in 10 days prior to enrolment
•Known allergic reactions to HCQ or azithromycin
•Inability to take/receive enteral medication
•Inability to be contacted on D14 for clinical outcome assessment (unless died in hospital)

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