Abstract. The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical ventilation ( P = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.
【초록키워드】 Randomized controlled trial, Treatment, Efficacy, therapy, Hydroxychloroquine, mechanical ventilation, COVID-19 pandemic, Ventilation, Randomized, Patient, Controlled trial, death, Laboratory parameters, Informed consent, HCQ, mortality rate, multicenter, mortality rates, COVID-19 patients, primary endpoint, exponential growth, Logistic regression analysis, control group, two groups, no significant difference, baseline characteristics, control arm, decreased mortality, overall mortality, primary endpoints, standard care, Univariate logistic regression analysis, growth, university hospital, Administered, effective, benefit, decrease, not differ, develop, evaluate, died, significantly, conducted, added, two group, did not reduce, age and gender, diagnosis of COVID-19, patients with COVID-19, 【제목키워드】 Hydroxychloroquine, Controlled,