Clinical characteristics of liver injury in SARS-CoV-2 Omicron variant- and Omicron subvariant-infected patients

Deng, Huiyan; Mai, Yuzhen; Liu, Huiyuan; Guan, Jialong

doi:10.1016/j.aohep.2022.100763

Cited by 7 publications

(7 citation statements)

References 25 publications

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“…In the present study, the incidence of TRAEs was infrequent; all AEs were grade 1 or 2 in severity, and the majority recovered within 3 days. Considering the HH‐120 nasal spray had undetectable systemic exposure as demonstrated in preclinical studies 26 and in a Phase 1 study in healthy subjects (NCT05753878, manuscript under preparation), the two AEs with ALT increase are probably not related to the HH‐120 nasal spray; it is more likely that they are related to the comorbidities both participants had at baseline and/or to liver injury caused by SARS‐CoV‐2 infection 43,44 …”

Section: Discussionmentioning

confidence: 99%

“…Another ACE2 fusion protein, APN01, was shown to be safe and well-tolerated via infusion or aerosol administration and was clinically investigated as an intervention for treating COVID-19 (NCT04335136, NCT05065645, and NCT04924660). In the present study, the incidence of TRAEs was infrequent; all AEs were grade 1 or 2 in severity, and the majority recovered within 3 days.Considering the HH-120 nasal spray had undetectable systemic exposure as demonstrated in preclinical studies26 and in a Phase 1 study in healthy subjects (NCT05753878, manuscript under preparation), the two AEs with ALT increase are probably not related to the HH-120 nasal spray; it is more likely that they are related to the comorbidities both participants had at baseline and/or to liver injury caused by SARS-CoV-2 infection 43,44. Prophylactic and therapeutic options for managing COVID-19 remain limited, and clinicians are now facing challenges including COVID-19 vaccine hesitancy and vulnerable populations with contraindications to available small-molecule antiviral drugs and vaccines 6.…”

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confidence: 99%

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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

Chen

et al. 2023

Journal of Medical Virology

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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, 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.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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

Chen

et al. 2023

Journal of Medical Virology

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“…Although SARS-CoV-2 primarily affects the respiratory system, several studies highlight the impact of this viral infection on other organs ( Guan et al, 2020 ; Xu L. et al, 2020 ; Zhang C. et al, 2020 ; Skok et al, 2021 ; Jansen et al, 2022 ). Deng et al (2022) reported that patients with SARS-CoV-2 infection might develop liver damage. To understand the effect of SARS-CoV-2 vaccines on long-term health consequences of adult patients infected with Omicron, we collected and analyzed the liver and kidney function-related data from convalescent adult patients.…”

Section: Discussionmentioning

confidence: 99%

Effects of vaccines on clinical characteristics of convalescent adult patients infected with SARS-CoV-2 Omicron variant: A retrospective study

et al. 2023

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IntroductionThe protective effect of SARS-CoV-2 vaccines has become a global focus due to Omicron variant pandemic. The effects of various SARS-CoV-2 vaccines are diverse. However, studies on the effect of domestic vaccines on clinical characteristics in convalescent adult patients infected with the Omicron variant are lacking.MethodsIn this retrospective, single-center cohort study, the effect of three domestic vaccines on clinical characteristics of convalescent adult patients infected with the Omicron variant was investigated in the initial largest outbreak of the Omicron variant infection between January and February 2022 in Tianjin, China. The primary endpoint was COVID-19 severity and the secondary endpoints were re-positive results on nucleic acid tests, liver and kidney function, and inflammation levels during recovery.ResultsA total of 320 adult patients infected with the Omicron variant were enrolled, including 296 post-vaccination and 24 unvaccinated patients. The median age of the unvaccinated patients was higher than that of vaccinated patients, but no significant difference was detected in the sex composition ratio between the different groups. Binary logistic regression results suggested that Sinopharm and Sinovac vaccine was an independent protective factor for relieving the severity of the Omicron variant infection. Regrettably, the vaccines did not showed any protective effect on the liver and kidney function of convalescent adult patients. Three domestic vaccines significantly relieved inflammation and increased the SARS-CoV-2-specific antibody levels. Furthermore, Sinovac and CanSino vaccines had a better immune stimulation effect on increasing T lymphocytes levels in convalescent adult patients. In addition, three domestic vaccines have protective effects on preventing re-detectable positive (RP) result in convalescent adult patients.ConclusionAlthough the three domestic vaccines cannot prevent the infection of the Omicron variant, it has a significant protective effect in adult patients. This study supports the policy of accelerating to vaccination worldwide combat the evolving and mutating SARS-CoV-2.DiscussionOmicron spreads faster and might escape antibodies more readily than previous variants, increasing the cases of reinfection and breakthrough infections in vaccinated people. Although vaccinated people are likely to have a much lower risk of severe disease from Omicron infection, many issues still need to be considered. Concerns about lower vaccine efficacy because of new variants might have changed our understanding of the COVID-19 endgame, disabusing the world of the notion that global vaccination is by itself adequate for controlling SARS-CoV-2 infection. The current data showed that vaccination with three domestic SARS-CoV-2 vaccines alleviates the disease severity of adult patients with COVID-19, reduces the inflammation level and the RP rate of convalescent adult patients, and enhances body’s defense against the virus in convalescent adult patients. Moreover, our study has highlighted that a combination prevention approach of vaccination and public health measures would be an effective strategy.

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“…Other medical indicators included D-D grade (>400 µg/L), activated partial thromboplastin time (APTT) classification (>40 s), thrombin time (TT) classification (>18 s), prothrombin activity (PTa) classification (>120%), PT classification (>13.8 s), and fibrinogen classification (>4 g/L). Liver injury was defined as follows: among these liver function test parameters, ALT, AST, TBA, alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), or total bilirubin (TBIL) exceeded the upper limit of normal value or albumin was lower than the lower limit of normal value [13]. The patients were classified according to this definition as ALT, AST, ALP, GGT, or TBIL.…”

Section: Data Collectionmentioning

confidence: 99%

“…The most frequent abnormalities included hypoalbuminemia, followed by elevated GGT, ALT, bilirubin, and ALP levels [23]. According to a retrospective study of the Omicron variant by Deng et al, liver function abnormalities were predominantly characterized by mild elevations in markers of choanocytes or biliary duct injury (TBIL, ALP, or GGT) in Omicron-infected patients [13]. Another retrospective study by Feng et al revealed a greater risk of liver injury in Omicron-infected patients, with liver injury observed in up to 23.7% of COVID-19 patients.…”

Section: Impact Of the Omicron Variant On Liver Function In Patients ...mentioning

confidence: 99%

Impact of Omicron variant infection on the liver, kidney, and coagulation system in patients undergoing elective surgery: a retrospective case-control study

Xiong,

Li,

Pei

et al. 2024

Int. J. Med. Sci.

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Purpose: We aimed to investigate the impact of Omicron variant infection on the perioperative organ function in patients undergoing elective surgery. Methods: A total of 5029 patients who underwent elective surgery between October 2022 and January 2023 at our hospital were enrolled. Among them, the patients who underwent elective surgery between October 2022 and November 2022 composed Group 1 (not infected with the Omicron variant) the control group; those who underwent elective surgery between December 2022 and January 2023 composed Group 2 (one month after Omicron variant infection) the experimental group. We further divided the patients into two subgroups for analysis: the tumor subgroup and the nontumor subgroup. Data on organ system function indicators, including coagulation parameters, liver function, complete blood count (CBC), and kidney function, were collected before and after surgery. Differences between the two groups were subsequently analyzed via binary logistic regression analysis. Results: Compared with those in the uninfected patient group, the following changes were observed in patients with Omicron variant infection who underwent elective surgery one month after infection: prothrombin activity (PTa), prothrombin time (PT), fibrinogen, albumin/globulin, alanine aminotransferase (ALT), mean corpuscular hemoglobin concentration (MCHC), platelet (PLT), and anemia were increased AST/ALT, indirect bilirubin (IBILI), eosinophils, and uric acid were decreased before surgery; and lung infection/pneumonia and fibrinogen were increased, while AST/ALT, globulin, total bilirubin (TBIL), white blood cell count (WBC), and uric acid were decreased after surgery. There was no significant difference in the mortality rate or length of hospital stay (LOS) between the two groups. Subgroup analysis revealed elevated monocyte, PLT, and fibrinogen classification, levels and decreased globulin, prealbumin (PBA), eosinophil, and uric acid levels in the tumor subgroup of patients who underwent elective surgery one month after Omicron infection compared with those in the uninfected patients. Compared with the nontumor subgroup, fibrinogen levels, lung infection/pneumonia, TBIL, and PLT count were increased in the uninfected patients, while the globulin and eosinophil levels were decreased. Conclusion: Compared with uninfected patients, patients who underwent elective surgery one month after Omicron variant infection exhibited minimal changes in perioperative coagulation parameters, liver function, CBC counts, and kidney function. Additionally, no significant differences in postoperative mortality or LOS were observed between the two groups.

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Clinical characteristics of liver injury in SARS-CoV-2 Omicron variant- and Omicron subvariant-infected patients

Cited by 7 publications

References 25 publications

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

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

Effects of vaccines on clinical characteristics of convalescent adult patients infected with SARS-CoV-2 Omicron variant: A retrospective study

Impact of Omicron variant infection on the liver, kidney, and coagulation system in patients undergoing elective surgery: a retrospective case-control study

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