Abstract：
HH-120, an IgM-like angiotensin converting enzyme 2 (ACE2) fusion protein, has been developed as a nasal spray against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is currently undergoing human trials. HH-120 nasal spray was assessed for postexposure prophylaxis (PEP) in two investigator-initiated (NS01 and NS02) trials with different risk levels of SARS-CoV-2 exposure. NS01 enrolled family caregiver participants who had continuous contacts with laboratory-confirmed index cases; NS02 enrolled participants who had general contacts (Part 1) or close contacts (Part 2) with index cases. The primary endpoints were safety and laboratory-confirmed and/or symptomatic SARS-CoV-2 infection. In NS01 trial (14 participants), the SARS-CoV-2 infection rates were 25% in the HH-120 group and 83.3% in the external control group (relative risk reduction [RRR]: 70.0%). In NS02-Part 1 (193 participants), the infection rates were 4% (HH-120) versus 11.3% (placebo), symptomatic infection rates were 0.8% versus 3.5%, hence with a RRR of 64.6% and 77.1%, respectively. In Part 2 (76 participants), the infection rates were 17.1% (HH-120) versus 30.4% (placebo), symptomatic infection rates were 7.5% versus 27.3%, with a RRR of 43.8% and 72.5%, respectively. No HH-120-related serious adverse effects were observed. The HH-120 nasal spray used as PEP was safe and effective in preventing laboratory-confirmed and symptomatic SARS-CoV-2 infection.
摘要：
HH-120，一种IgM样血管紧张素转换酶2（ACE2）融合蛋白，已被开发为针对严重急性呼吸道综合症冠状病毒2（SARS-CoV-2）的鼻喷雾剂，目前正在进行人体试验。在两项研究人员发起的（NS01和NS02）试验中，评估了HH-120鼻喷雾剂的暴露后预防（PEP），这些试验具有不同的SARS-CoV-2暴露风险水平。NS01招募了与实验室确认的指标病例有持续接触的家庭照顾者参与者；NS02招募了与指标病例有一般接触（第1部分）或密切接触（第2部分）的参与者。主要终点是安全性和实验室确认和/或有症状的SARS-CoV-2感染。在NS01试验中(14名参与者)，HH-120组SARS-CoV-2感染率为25％，外部对照组为83.3％（相对风险降低[RRR]：70.0％）。在NS02-第1部分(193名参与者)中，感染率分别为4%(HH-120)和11.3%(安慰剂)，症状感染率分别为0.8%和3.5%,因此，存款准备金率为64.6%和77.1%，分别。在第二部分(76名参与者)中，感染率分别为17.1%（HH-120）和30.4%（安慰剂），症状感染率分别为7.5%和27.3%,RRR分别为43.8%和72.5%，分别。没有观察到HH-120相关的严重不良反应。用作PEP的HH-120鼻喷雾剂可安全有效地预防实验室确认和有症状的SARS-CoV-2感染。
