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

Song et al., Journal of Medical Virology, doi:10.1002/jmv.28805

May 2023

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PSM analysis of 65 HH-120 patients and 103 controls contemporaneously hospitalized in the same hospital, showing faster viral clearance with HH-120 treatment, with improved results for patients with higher baseline viral load.

Standard of Care (SOC): SOC for COVID-19 in the study country, China, is average with moderate average efficacy for approved treatments1.

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time to viral-, 20.0% lower, relative time 0.80, p = 0.001, treatment 65, control 103, propensity score matching.

time to viral-, 28.6% lower, relative time 0.71, p = 0.001, higher baseline viral load, propensity score matching.

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1. c19early.org, c19early.org/soc/china.html.c19early.org/soc/china.html.

Song et al., 25 May 2023, retrospective, China, peer-reviewed, 13 authors, study period 3 August, 2022 - 7 October, 2022.

This Paper HH-120 All

DOI record: { "DOI": "10.1002/jmv.28805", "ISSN": [ "0146-6615", "1096-9071" ], "URL": "http://dx.doi.org/10.1002/jmv.28805", "abstract": "AbstractHH‐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, p < 0.001); the difference was more prominent in those subgroup subjects with higher baseline viral load (median 7.5 days vs. 10.5 days, p < 0.001). The incidence of treatment‐emergent adverse events and treatment‐related adverse events of 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.", "alternative-id": [ "10.1002/jmv.28805" ], "assertion": [ { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Received", "name": "received", "order": 0, "value": "2023-02-27" }, { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Accepted", "name": "accepted", "order": 1, "value": "2023-05-08" }, { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Published", "name": "published", "order": 2, "value": "2023-05-25" } ], "author": [ { "affiliation": [ { "name": "Beijing Ditan Hospital Capital Medical University Beijing China" } ], "family": "Song", "given": "Rui", "sequence": "first" }, { "affiliation": [ { "name": "Beijing Ditan Hospital Capital Medical University Beijing China" } ], "family": "Chen", "given": "Xiaoyou", "sequence": "additional" }, { "affiliation": [ { "name": "Beijing Ditan Hospital Capital Medical University Beijing China" } ], "family": "Li", "given": "Baoliang", "sequence": "additional" }, { "affiliation": [ { "name": "Huahui Health Ltd. 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