Novel Coronavirus Pneumonia Prevention and Control Team, Taihe Hospital, Hubei University of Medicine, 442000, Shiyan, Hubei, China.
Department of Gastroenterology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 200127, Shanghai, China.
Curr Top Med Chem. 2021;21(10):920-927. doi: 10.2174/1568026621666210429083050.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), known as Coronavirus disease-2019 (COVID-19), has caused the sixth world's public health emergency. Healthcare staff, as the frontline population fighting the pandemic, are exposed to a high risk of infection. Therefore, developing a protective intervention for medical staff is of significant importance.
The aim of the study was to explore the effectiveness and safety of recombinant human interferon alpha (rhIFN-α) nasal drops for the prevention of coronavirus disease 2019 (COVID-19) through administering it to medical staff.
This was a prospective open-label clinical trial with parallel intervention assignment conducted on 2944 medical staff including both doctors and nurses from Taihe Hospital, Shiyan City, Hubei Province, China from January 21, 2020 to July 30, 2020. The participants were bifurcated into two groups of low risk and high risk groups according to the level of direct exposure to COVID-19 patients. The individuals of the low-risk group received rhIFN-α nasal drops for one month in addition to first level protection, and the high-risk group received a combination of rhIFN-α nasal drops coupled with thymosin-α1 with either second or third-level protection protocol. Moreover, the new-outset of COVID-19 pneumonia diagnosed by chest computed tomography (CT), after thirty days, was the primary outcome. The adverse reactions were recorded in all participants.
2415 of 2944 individuals belonged to the low-risk group, while 529 to the high-risk group. There was no COVID-19 pneumonia in either of the group after thirty days. The pulmonary CT scans were negative for COVID-19 pneumonia in both the groups with no new clinical symptoms. No serious adverse event was observed during the course of the intervention.
The rhIFN-α nasal drops along with augmented safeguards based on standard physical isolation could effectively protect medical staff against COVID-19 pneumonia.
严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2），即新型冠状病毒疾病 2019（COVID-19），已引发第六次世界公共卫生紧急事件。医护人员作为抗击疫情的一线人群，面临着较高的感染风险。因此，为医护人员开发防护干预措施至关重要。
本研究旨在通过对医护人员使用重组人干扰素α（rhIFN-α）鼻喷剂，探索其预防 2019 年冠状病毒病（COVID-19）的有效性和安全性。
这是一项在中国湖北省十堰市太和医院于 2020 年 1 月 21 日至 7 月 30 日期间开展的 2944 名医护人员（包括医生和护士）参与的、前瞻性、开放性标签、平行干预分配的临床试验。根据医护人员直接接触 COVID-19 患者的程度，将参与者分为低风险和高风险两组。低风险组在一级防护的基础上，使用 rhIFN-α 鼻喷剂治疗一个月；高风险组则在二级或三级防护方案中，联合使用 rhIFN-α 鼻喷剂和胸腺肽-α1。此外，主要结局为治疗后 30 天通过胸部计算机断层扫描（CT）诊断出的新发 COVID-19 肺炎。记录所有参与者的不良反应。
2944 名参与者中，2415 人属于低风险组，529 人属于高风险组。30 天后，两组均未出现 COVID-19 肺炎。两组的肺部 CT 扫描均未见 COVID-19 肺炎的阳性征象，且无新的临床症状。在干预过程中，未观察到严重不良事件。
rhIFN-α 鼻喷剂联合基于标准物理隔离的增强防护措施可有效保护医护人员免受 COVID-19 肺炎的侵害。
