Tissue Engineering and Regenerative Medicine Unit, Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra, Mexico City, Mexico
Division of Traumatology, Emergencies and Bone Infections, Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.
BMJ Open. 2021 Aug 3;11(8):e045190. doi: 10.1136/bmjopen-2020-045190.
SARS-CoV-2 infection in Mexico has caused ~2.7 million confirmed cases; around 20%-25% of health workers will be infected by the virus at their workplace, with approximately 4.4% of mortality. High infectivity of SARS-CoV-2 is related with cell entry mechanism, through the ACE receptor. SARS-CoV-2 requires transmembrane protease serine 2 to cleave its spike glycoprotein and ensure fusion of host cell and virus membrane. We propose studying prophylactic treatment with hydroxychloroquine (HCQ) and bromhexine (BHH), which have been shown to be effective in preventing SARS-CoV-2 infection progression when administered in early stages. The aim of this study is to assess the efficacy of HCQ and BHH as prophylactic treatments for SARS-CoV-2 infection in healthy health workers exposed to the virus.
Double-blind randomised clinical trial, with parallel allocation at a 1:1 ratio with placebo, of low doses of HCQ plus BHH, for 60 days. Study groups will be defined as follows: (1) HCQ 200 mg/day+BHH 8 mg/8 hours versus (2) HCQ placebo plus BHH placebo. Primary endpoint will be efficacy of both interventions for the prevention of SARS-CoV-2 infection, determined by the risk ratio of infected personnel and the absolute risk. At least a 16% reduction in absolute risk is expected between the intervention and placebo groups; a minimum of 20% infection is expected in the placebo group. The sample size calculation estimated a total of 214 patients assigned: two groups of 107 participants each.
This protocol has been approved by the local Medical Ethics Committee (National Institute of Rehabilitation 'Luis Guillermo Ibarra Ibarra', approval number INRLGII/25/20) and by the Federal Commission for Protection against Sanitary Risks (COFEPRIS, approval number 203 300 410A0058/2020). The results of the study will be submitted for publication in peer-reviewed journals and disseminated through conferences.
NCT04340349.
墨西哥的 SARS-CoV-2 感染已导致约 270 万例确诊病例；约 20%-25%的卫生工作者将在工作场所感染该病毒，死亡率约为 4.4%。SARS-CoV-2 的高传染性与其细胞进入机制有关，通过 ACE 受体。SARS-CoV-2 需要跨膜蛋白酶丝氨酸 2 来切割其刺突糖蛋白，并确保宿主细胞与病毒膜融合。我们建议研究使用羟氯喹（HCQ）和溴己新（BHH）的预防性治疗，当在早期给药时，这两种药物已被证明可有效预防 SARS-CoV-2 感染的进展。本研究的目的是评估 HCQ 和 BHH 作为预防健康卫生工作者暴露于病毒时 SARS-CoV-2 感染的治疗效果。
这是一项双盲随机临床试验，采用低剂量 HCQ 加 BHH 的平行分配，为期 60 天。研究组将分为以下两组：（1）HCQ 200mg/天+BHH 8mg/8 小时，（2）HCQ 安慰剂+ BHH 安慰剂。主要终点是两种干预措施预防 SARS-CoV-2 感染的效果，通过感染人员的风险比和绝对风险来确定。干预组与安慰剂组的绝对风险预计降低 16%以上；预计安慰剂组的感染率至少为 20%。根据预计安慰剂组有 20%的感染率，计算出需要 214 名患者入组：两组各 107 名患者。
该方案已获得当地医学伦理委员会（国家康复研究所“Luis Guillermo Ibarra Ibarra”，批准号 INRLGII/25/20）和联邦保护卫生风险委员会（COFEPRIS，批准号 203 300 410A0058/2020）的批准。研究结果将提交给同行评议期刊发表，并通过会议传播。
NCT04340349。
