Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 accelerates SARS‐CoV‐2 clearance: A single‐center propensity score‐matched cohort study

{ 'indexed': {'date-parts': [[2023, 12, 6]], 'date-time': '2023-12-06T18:08:50Z', 'timestamp': 1701886130182}, 'reference-count': 44, 'publisher': 'Wiley', 'issue': '5', 'license': [ { 'start': { 'date-parts': [[2023, 5, 25]], 'date-time': '2023-05-25T00:00:00Z', 'timestamp': 1684972800000}, 'content-version': 'vor', 'delay-in-days': 24, 'URL': 'http://onlinelibrary.wiley.com/termsAndConditions#vor'}], 'content-domain': {'domain': ['onlinelibrary.wiley.com'], 'crossmark-restriction': True}, 'published-print': {'date-parts': [[2023, 5]]}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec><jats:label /><jats:p>HH‐120, a recently developed ' 'IgM‐like ACE2 fusion protein with broad‐spectrum neutralizing activity against all ' 'ACE2‐utilizing coronaviruses, has been developed as a nasal spray for use as an early ' 'treatment agent to reduce disease progression and airborne transmission. The objective of ' 'this study was to evaluate the safety and efficacy of the HH‐120 nasal spray in ' 'SARS‐CoV‐2‐infected subjects. Eligible symptomatic or asymptomatic SARS‐CoV‐2‐infected ' 'participants were enrolled in a single‐arm trial to receive the HH‐120 nasal spray for no ' 'longer than 6 days or until viral clearance at a single hospital between August 3 and October ' '7, 2022. An external control was built from real‐world data of SARS‐CoV‐2‐infected subjects ' 'contemporaneously hospitalized in the same hospital using a propensity score matching (PSM) ' 'method. After PSM, 65 participants in the HH‐120 group and 103 subjects with comparable ' 'baseline characteristics in the external control group were identified. The viral clearance ' 'time was significantly shorter in participants receiving the HH‐120 nasal spray than that in ' 'subjects of the control group (median 8 days vs. 10 days, <jats:italic>p</jats:italic>\u2009' '&lt;\u20090.001); the difference was more prominent in those subgroup subjects with higher ' 'baseline viral load (median 7.5 days vs. 10.5 days, <jats:italic>p</jats:italic>\u2009' '&lt;\u20090.001). The incidence of treatment‐emergent adverse events\xa0and treatment‐related ' 'adverse events\xa0of HH‐120 group were 35.1% (27/77) and 3.9% (3/77), respectively. All the ' 'adverse events observed were mild, being of CTCAE grade 1 or 2, and transient. The HH‐120 ' 'nasal spray showed a favorable safety profile and promising antiviral efficacy in ' 'SARS‐CoV‐2‐infected subjects. The results from this study warrant further assessment of the ' 'efficacy and safety of the HH‐120 nasal spray in large‐scale randomized controlled clinical ' 'trials.</jats:p></jats:sec>', 'DOI': '10.1002/jmv.28805', 'type': 'journal-article', 'created': {'date-parts': [[2023, 5, 25]], 'date-time': '2023-05-25T11:54:04Z', 'timestamp': 1685015644000}, 'update-policy': 'http://dx.doi.org/10.1002/crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 2, 'title': 'Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 accelerates SARS‐CoV‐2 clearance: A ' 'single‐center propensity score‐matched cohort study', 'prefix': '10.1002', 'volume': '95', 'author': [ { 'given': 'Rui', 'family': 'Song', 'sequence': 'first', 'affiliation': [{'name': 'Beijing Ditan Hospital Capital Medical University Beijing China'}]}, { 'given': 'Xiaoyou', 'family': 'Chen', 'sequence': 'additional', 'affiliation': [{'name': 'Beijing Ditan Hospital Capital Medical University Beijing China'}]}, { 'given': 'Baoliang', 'family': 'Li', 'sequence': 'additional', 'affiliation': [{'name': 'Beijing Ditan Hospital Capital Medical University Beijing China'}]}, { 'given': 'Hongbin', 'family': 'Zhang', 'sequence': 'additional', 'affiliation': [{'name': 'Huahui Health Ltd. Beijing China'}]}, { 'given': 'Xiaodi', 'family': 'Guo', 'sequence': 'additional', 'affiliation': [{'name': 'Beijing Ditan Hospital Capital Medical University Beijing China'}]}, { 'given': 'Zhe', 'family': 'Liu', 'sequence': 'additional', 'affiliation': [{'name': 'Beijing Ditan Hospital Capital Medical University Beijing China'}]}, { 'given': 'Liangfeng', 'family': 'Zou', 'sequence': 'additional', 'affiliation': [{'name': 'Huahui Health Ltd. Beijing China'}]}, { 'given': 'Xiao', 'family': 'Liang', 'sequence': 'additional', 'affiliation': [{'name': 'Huahui Health Ltd. Beijing China'}]}, { 'given': 'Cong', 'family': 'Lei', 'sequence': 'additional', 'affiliation': [{'name': 'Huahui Health Ltd. Beijing China'}]}, { 'given': 'Fengfeng', 'family': 'Mao', 'sequence': 'additional', 'affiliation': [{'name': 'Huahui Health Ltd. 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