Administration of HeberFERON in Patients with Persistent Oropharyngeal SARS-CoV-2 Wuhan/D614G Strain Viral Shedding

I. Campa-Legrá, J. Lence, Marel Alonso-Valdés, Marisol Diaz-Galvez, Adriana Sin-Mayor, M. García-Sánchez, Sara Martinez-Martin, J. Perez-Escribano, Idelsis Esquivel-Moynelo, Y. Duncan-Roberts, Claudia Martu00ednez-Suarez, Abraham Beato-Canfuk, I. Bello-Rivero
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Abstract

Study background: HeberFERON accelerates SARS-CoV-2 clearance in COVID-19 cases. Considering this we evaluated the employment of HeberFERON in patients with more than 14 days of viral shedding. Methods: This is a case series study of mild or moderate ill patients with laboratory-confirmed SARS-CoV-2 from one hospital in Havana, Cuba. We evaluated the effect and safety of HeberFERON in patients previously treated with Heberon Apha R that resulted with prolonged viral shedding. All patients received lopinavir-ritonavir 200/50 mg every 12 h and chloroquine 250 mg every 12 h. The primary endpoint was the time to negativization of viral RNA in patients with persistent viral shedding. The protocol was approved by the Ethics Committee of the Luis Diaz Soto Hospital. Results: The characteristics of the individuals included the age ranged from 19-87 years with a mean of 40 years, (Study and Control I groups), while in the Control group II the mean age was 43.8 years. Leukocytes, platelets, neutrophils, and eosinophils, show a significantly lower counts in the groups with viral persistence. Under IFN treatment the median viral shedding duration from diagnosis were 21 days and 19 days in Study group and Control group II, respectively. The Control group I showed a median viral shedding of 11 days (log-rank p = 0.000). Significant longer median viral negativization time (19 days) of symptomatic than asymptomatic patients (11 days, Long-rank p = 0.004), was observed. In patients under Heberon Alpha R treatment that resulted persistent for viral presence, the median time to viral negativization was 7 days for the period of administration of HeberFERON. Being symptomatic at diagnosis was significantly associated with viral persistence. The HeberFERON showed an adequate safety profile. Conclusion: HeberFERON showed a safe and rapid negativization of patients with viral persistence, achieving negativization in more than 50% of patients in 7 days.
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HeberFERON在持续口咽SARS-CoV-2武汉/D614G株病毒脱落患者中的应用
研究背景:HeberFERON可加速COVID-19患者对SARS-CoV-2的清除。考虑到这一点,我们评估了HeberFERON在病毒脱落超过14天的患者中的应用。方法:对来自古巴哈瓦那一家医院的实验室确诊的SARS-CoV-2轻、中度患者进行病例系列研究。我们评估了HeberFERON在先前接受Heberon Apha R治疗导致病毒脱落时间延长的患者中的效果和安全性。所有患者均接受洛匹那韦-利托那韦200/50 mg / 12 h和氯喹250 mg / 12 h的治疗。主要终点是持续病毒脱落患者的病毒RNA阴性时间。该议定书得到了路易斯·迪亚兹·索托医院伦理委员会的批准。结果:患者年龄19 ~ 87岁,平均40岁(研究组和对照组),对照组平均年龄43.8岁。白细胞、血小板、中性粒细胞和嗜酸性粒细胞在病毒持续存在的组中计数明显降低。在IFN治疗下,研究组和对照组II的病毒从诊断开始的中位病毒脱落时间分别为21天和19天。对照组I显示病毒脱落的中位数为11天(log-rank p = 0.000)。有症状患者的中位病毒阴性时间(19 d)明显高于无症状患者(11 d, Long-rank p = 0.004)。在接受Heberon Alpha R治疗导致病毒持续存在的患者中,HeberFERON给药期间病毒阴性的中位时间为7天。诊断时出现症状与病毒持续性显著相关。HeberFERON显示出足够的安全性。结论:HeberFERON对病毒持续存在的患者表现出安全、快速的阴性反应,在7天内超过50%的患者实现了阴性反应。
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