Association between loss of hypercoagulable phenotype, clinical features and complement pathway consumption in COVID-19.

Background: Coronavirus disease 2019 (COVID-19) features a hypercoagulable state, but therapeutic anticoagulation effectiveness varies with disease severity. We aimed to evaluate the dynamics of the coagulation profile and its association with COVID-19 severity, outcomes, and biomarker trajectories. Methods: This multicenter, prospective, observational study included patients with COVID-19 requiring respiratory support. Rotational thromboelastometry findings were evaluated for coagulation and fibrinolysis status. Hypercoagulable status was defined as supranormal range of maximum clot elasticity in an external pathway. Longitudinal laboratory parameters were collected to characterize the coagulation phenotype. Results: Of 166 patients, 90 (54%) were severely ill at inclusion (invasive mechanical ventilation, 84; extracorporeal membrane oxygenation, 6). Higher maximum elasticity (P=0.02) and lower maximum lysis in the external pathway (P=0.03) were observed in severely ill patients compared with the corresponding values in patients on non-invasive oxygen supplementation. Hypercoagulability components correlated with platelet and fibrinogen levels. Hypercoagulable phenotype was associated with favorable outcomes in severely ill patients, while normocoagulable phenotype was not (median time to recovery, 15 days vs. 27 days, P=0.002), but no significant association was observed in moderately ill patients. In patients with severe COVID-19, lower initial C3, minimum C3, CH50, and greater changes in CH50 were associated with the normocoagulable phenotype. Changes in complement components correlated with dynamics of coagulation markers, hematocrit, and alveolar injury markers. Conclusions: While hypercoagulable states become more evident with increasing severity of respiratory disease in patients with COVID-19, normocoagulable phenotype is associated with triggered by alternative pathway activation and poor outcomes.

Mild elevation of pulmonary vascular resistance predicts mortality regardless of mean pulmonary artery pressure in mild interstitial lung disease.

BACKGROUND: Pulmonary hypertension (PH) is defined by elevated mean pulmonary arterial pressure (MPAP), and elevated pulmonary vascular resistance (PVR) reflects pulmonary vascular abnormalities. The clinical significance of non-severe PH in patients with various interstitial lung diseases (ILDs) has not been fully elucidated. We aimed to investigate the clinical significance of MPAP and PVR for mortality in patients with newly diagnosed ILD. METHODS: We retrospectively analysed consecutive patients with ILD at initial evaluations that included right heart catheterisation from 2007 to 2018. These patients were classified by MPAP and PVR using the 2022 the European Society of Cardiology (ESC)/the European Respiratory Society (ERS) guidelines for PH. The clinical significance of MPAP and PVR for mortality was analysed. RESULTS: Among 854 patients, 167 (19.6%) had MPAP>20 mm Hg. The proportion of patients with PVR>2 Wood units (WU) among those with MPAP≤20 mm Hg, 202 WU was associated with a higher mortality rate (HR 1.61, 95% CI 1.28 to 2.02, p<0.0001) even in a group with MPAP≤20 mm Hg. CONCLUSIONS: Mild elevation of PVR was associated with a higher mortality rate in patients with newly diagnosed ILD, even in those with MPAP≤20 mm Hg.

Continuous positive airway pressure versus high-flow nasal cannula oxygen therapy for acute hypoxemic respiratory failure: A randomized controlled trial.

BACKGROUND AND OBJECTIVE: The relative effectiveness of initial non-invasive respiratory strategies for acute respiratory failure using continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) is unclear. METHODS: We conducted a multicenter, open-label, parallel-group randomized controlled trial to compare the efficacy of CPAP and HFNC on reducing the risk of meeting the prespecified criteria for intubation and improving clinical outcomes of acute hypoxemic respiratory failure. The primary endpoint was the time taken to meet the prespecified criteria for intubation within 28 days. RESULTS: Eighty-five patients were randomly assigned to the CPAP or HFNC group. Eleven (28.9%) in the CPAP group and twenty (42.6%) in the HFNC group met the criteria for intubation within 28 days. Compared with HFNC, CPAP reduced the risk of meeting the intubation criteria (hazard ratio [HR], 0.327; 95% CI, 0.148-0.724; p = 0.006). There were no significant between-group differences in the intubation rates, in-hospital and 28-day mortality rates, ventilator-free days, duration of the need for respiratory support, or duration of hospitalization for respiratory illness. Pulmonary oxygenation was significantly better in the CPAP group, with significantly lower pH and higher partial pressure of carbon dioxide, but there were no differences in the respiratory rate between groups. CPAP and HFNC were associated with few possibly causal adverse events. CONCLUSION: CPAP is more effective than HFNC at reducing the risk of meeting the intubation criteria in patients with acute hypoxemic respiratory failure.

Disease progression and changes in KL-6 in patients with limited cutaneous systemic sclerosis-associated interstitial lung disease.

BACKGROUND: Little is known about the annual change in Krebs von Lungen-6 (KL-6) and its correlation with forced vital capacity (FVC) in limited cutaneous systemic sclerosis-associated interstitial lung disease (lcSSc-ILD). We aimed to clarify the correlation during the clinical course. METHODS: We retrospectively reviewed data from consecutive patients with lcSSc-ILD. We measured FVC and KL-6 annually and calculated their annual changes using the difference in absolute values. Decline in FVC was defined as annual decline in FVC ≥5 %. RESULTS: Thirty-eight patients with SSc-ILD were included. The median age was 62 years and 58 % were female. The median FVC was 87.3 % and the median KL-6 was 1629 U/ml. The median observation period was 55.2 months and the annual changes in FVC and KL-6 were evaluated 151 times simultaneously. The annual change in KL-6 had a significant negative correlation with that in FVC in the first year from the initial evaluation (from the baseline to one-year follow-up) (r = -0.819, p < 0.01), but not after the first year. In the multivariable analysis adjusted by age, sex, and FVC at each year, the annual change of KL-6 (per 100 U/ml) was significantly associated with decline in FVC in the first year (odds ratio: 3.03, 95 % confidence interval: 1.21-7.59, p = 0.02), but not after the first year. CONCLUSIONS: Only in the first year from the initial evaluation, there was negative correlation between the annual change in FVC and that in KL-6 and the annual elevation in KL-6 was associated with decline in FVC in patients with lcSSc-ILD.

Physical activity in idiopathic pulmonary fibrosis: Longitudinal change and minimal clinically important difference.

BACKGROUND AND OBJECTIVE: Reference values of physical activity to interpret longitudinal changes are not available in patients with idiopathic pulmonary fibrosis (IPF). This study aimed to define the minimal clinical important difference (MCID) of longitudinal changes in physical activity in patients with IPF. METHODS: Using accelerometry, physical activity (steps per day) was measured and compared at baseline and 6-months follow-up in patients with IPF. We calculated MCID of daily step count using multiple anchor-based and distribution-based methods. Forced vital capacity and 6-minute walk distance were applied as anchors in anchor-based methods. Effect size and standard error of measurement were used to calculate MCID in distribution-based methods. RESULTS: One-hundred and five patients were enrolled in the study (mean age: 68.5 ± 7.5 years). Step count significantly decreased from baseline to 6-months follow-up (-461 ± 2402, p = .031). MCID calculated by anchor-based and distribution-based methods ranged from 570-1358 steps. CONCLUSION: Daily step count significantly declined over 6-months in patients with IPF. MCID calculated by multiple anchor-based and distribution-based methods was 570 to 1358 steps/day. These findings contribute to interpretation of the longitudinal changes of physical activity that will assist its use as a clinical and research outcome in patients with IPF.

Changes in patient-reported outcomes in patients with non-idiopathic pulmonary fibrosis fibrotic interstitial lung disease and progressive pulmonary fibrosis.

Background: Health-related quality of life (HRQoL) captures different aspects of the fibrotic interstitial lung disease (FILD) evaluation from the patient's perspective. However, little is known about how HRQoL changes in patients with non-idiopathic pulmonary fibrosis (IPF) FILD, especially in those with progressive pulmonary fibrosis (PPF). The aim of this study is to clarify whether HRQoL deteriorates in patients with non-IPF FILD and to evaluate the differences in the changes in HRQoL between those with and without PPF. Methods: We collected data from consecutive patients with non-IPF FILD and compared annual changes in HRQoL over 2 years between patients with PPF and those without. The St George's respiratory questionnaire (SGRQ) and COPD assessment test (CAT) were used to assess HRQoL. Changes in the SGRQ and CAT scores for 24 months from baseline were evaluated with a mixed-effect model for repeated measures. Results: A total of 396 patients with non-IPF FILD were reviewed. The median age was 65 years and 202 were male (51.0%). The median SGRQ and CAT scores were 29.6 and 11, respectively. Eighty-six (21.7%) showed PPF. Both SGRQ and CAT scores were significantly deteriorated in patients with PPF compared to those without PPF (p < 0.01 for both). Clinically important deterioration in the SGRQ and CAT scores were observed in 40.0 and 35.7% of patients with PPF and 11.7 and 16.7% of those without, respectively. PPF was significantly associated with clinically important deterioration in the SGRQ score (odds ratio 5.04; 95%CI, 2.61-9.76, p < 0.01) and CAT score (odds ratio 2.78; 95%CI, 1.27-6.06, p = 0.02). Conclusion: The SGRQ and CAT scores were significantly deteriorated in patients with non-IPF FILD and PPF. Considering an evaluation of HRQoL would be needed when assessing PPF.

Interstitial pneumonia with autoimmune features and histologic usual interstitial pneumonia treated with anti-fibrotic versus immunosuppressive therapy.

BACKGROUND: Therapeutic strategies in patients with interstitial pneumonia with autoimmune features (IPAF) and histological usual interstitial pneumonia (UIP) pattern (IPAF-UIP) have not been thoroughly evaluated. We compared the therapeutic efficacy of anti-fibrotic therapy with that of immunosuppressive treatment for patients with IPAF-UIP. METHODS: In this retrospective case series, we identified consecutive IPAF-UIP patients treated with anti-fibrotic therapy or immunosuppressive therapy. Clinical characteristics, one-year treatment response, acute exacerbation, and survival were studied. We performed a stratified analysis by the pathological presence or absence of inflammatory cell infiltration. RESULTS: Twenty-seven patients with anti-fibrotic therapy and 29 with immunosuppressive treatment were included. There was a significant difference in one-year forced vital capacity (FVC) change between patients with anti-fibrotic treatment (4 in 27 improved, 12 stable, and 11 worsened) and those with immunosuppressive treatment (16 in 29 improved, eight stable, and five worsened) (p = 0.006). There was also a significant difference in one-year St George's Respiratory Questionnaire (SGRQ) change between patients with anti-fibrotic therapy (2 in 27 improved, ten stable, and 15 worsened) and those with immunosuppressive treatment (14 in 29 improved, 12 stable, and worsened) (p < 0.001). There was no significant difference in survival between the groups (p = 0.32). However, in the subgroup with histological inflammatory cell infiltration, survival was significantly better with immunosuppressive therapy (p = 0.02). CONCLUSION: In IPAF-UIP, immunosuppressive therapy seemed to be superior to anti-fibrotic treatment in terms of therapeutic response, and provided better outcomes in the histological inflammatory subgroup. Further prospective studies are needed to clarify the therapeutic strategy in IPAF-UIP.

Real-World Experience of the Comparative Effectiveness and Safety of Molnupiravir and Nirmatrelvir/Ritonavir in High-Risk Patients with COVID-19 in a Community Setting.

Molnupiravir (MOV) and nirmatrelvir/ritonavir (NMV/r) are efficacious oral antiviral agents for patients with the 2019 coronavirus (COVID-19). However, little is known about their effectiveness in older adults and those at high risk of disease progression. This retrospective single-center observational study assessed and compared the outcomes of COVID-19 treated with MOV and NMV/r in a real-world community setting. We included patients with confirmed COVID-19 combined with one or more risk factors for disease progression from June to October 2022. Of 283 patients, 79.9% received MOV and 20.1% NMV/r. The mean patient age was 71.7 years, 56.5% were men, and 71.7% had received ≥3 doses of vaccine. COVID-19-related hospitalization (2.8% and 3.5%, respectively; p = 0.978) or death (0.4% and 3.5%, respectively; p = 0.104) did not differ significantly between the MOV and NMV/r groups. The incidence of adverse events was 2.7% and 5.3%, and the incidence of treatment discontinuation was 2.7% and 5.3% in the MOV and NMV/r groups, respectively. The real-world effectiveness of MOV and NMV/r was similar among older adults and those at high risk of disease progression. The incidence of hospitalization or death was low.

Burnout and Turnover Intention in Critical Care Professionals During the COVID-19 Pandemic in Japan: A Cross-sectional Survey.

Rationale: The prevalence of burnout among critical care professionals during the coronavirus disease (COVID-19) pandemic varies in different countries. Objectives: To investigate the prevalence of burnout and turnover intention in Japanese critical care professionals in March 2021. Methods: This cross-sectional study used a web-based survey of Japanese critical care professionals working in 15 intensive care units in 15 prefectures. Burnout was measured using the Mini Z 2.0 Survey. Intention to leave (turnover intention) was assessed by survey. Resilience was measured using the Brief Resilience Scale (Japanese version). Demographics and personal and workplace characteristics were also collected. Results: Of 1,205 critical care professionals approached, 936 (77.6%) completed the survey. Among these, 24.3%, 20.6%, and 14.2% reported symptoms of burnout, depression, and anxiety, respectively. A total of 157 respondents (16.8%) reported turnover intention. On multivariate analysis, higher resilience scores (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.84-0.95; and OR, 0.94; 95% CI, 0.91-0.96) and perceived support from the hospital (OR, 0.64; 95% CI, 0.44-0.93; and OR, 0.54; 95% CI, 0.40-0.73) were associated with a lower odds of burnout and turnover intention, respectively. Conclusions: Approximately 24% and 17% of the Japanese critical care professionals surveyed had symptoms of burnout and turnover intention from critical care, respectively, during the COVID-19 pandemic. Such professionals require organizational support to cultivate both individual and organizational resilience to reduce burnout and turnover intention.

Impact of the no-touch harvesting technique on the vessel diameter of saphenous vein grafts for coronary artery bypass grafting.

Objectives: To explore the impact of the no-touch harvesting technique on the vessel diameter of saphenous vein grafts. Methods: This retrospective, single-center study enrolled 166 patients who underwent isolated coronary artery bypass grafting using saphenous vein grafts. Saphenous vein grafts were harvested conventionally in 83 patients (conventional group) and using the no-touch technique in 83 patients (no-touch group). We analyzed graft patency and the vessel diameters of saphenous vein grafts in the pre- and postoperative states. The diameter mismatch between the saphenous vein grafts and the coronary artery at the anastomotic site was also measured; preoperative diameter was measured using ultrasound imaging, and the postoperative diameter was measured using electrocardiogram-gated enhanced computed tomography. Results: A total of 135 saphenous vein grafts (66 and 69 grafts in the conventional and no-touch groups, respectively) were evaluated for postoperative patency. Graft patency was equivalent in the 2 groups (conventional, 96.9% vs no-touch, 100%; P = .24). A detailed evaluation was performed in 109 saphenous vein grafts (52 and 57 grafts in the conventional and no-touch groups, respectively). Saphenous vein graft diameter was significantly distended in the conventional group (preoperative, 2.6 ± 0.7 mm vs postoperative, 3.4 ± 0.5 mm; P < .0001). However, saphenous vein graft diameter did not change in the no-touch group (preoperative, 2.9 ± 0.4 mm vs postoperative 2.8 ± 0.4 mm, P = .33). The diameter mismatch was significantly smaller in the no-touch group (conventional 1.4 ± 0.6 mm vs no-touch 1.0 ± 0.4 mm, P < .0001). Conclusions: The no-touch technique avoids the expansion of graft diameter and diameter mismatch between the saphenous vein grafts and coronary artery.

Two cases of acute respiratory failure following SARS-CoV-2 vaccination in post-COVID-19 pneumonia.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination is a very effective method of preventing infection and is recommended for people having recovered from coronavirus disease 2019 (COVID-19). In this novel case report, we describe two patients with post-COVID-19 pneumonia who experienced acute respiratory failure and new bilateral ground-glass opacities several days after receiving SARS-CoV-2 vaccination. Both patients were treated with methylprednisolone pulse therapy and recovered from the disease successfully. Indeed, post-COVID-19 patients can gain benefits from the vaccine, but vaccination at the early stage of recovery from COVID-19 might be a risk for certain populations. These cases highlight a potential association between vaccination, interstitial lung disease and worsening of post-COVID-19 pneumonia. Further investigation and research examining the relationship between the timing of SARS-CoV-2 vaccination and potential risks in post-COVID-19 patients is recommended.

Fate of dissected arch vessels by adventitial inversion technique for acute type A aortic dissection repair.

OBJECTIVES: The adventitial inversion technique is used widely for aortic reconstruction for acute type A aortic dissection, as it easily controls the bleeding at anastomotic sites and closes the patent false lumen. However, this technique for arch vessel reconstruction has not been previously reported. Therefore, we applied the adventitial inversion technique for dissected arch vessel reconstruction to close the patent false lumen. METHODS: Among 57 consecutive patients who underwent emergency surgical treatment for acute type A aortic dissection from July 2006 to July 2012, the adventitial inversion technique for the dissected arch vessels was performed in 26 patients (42 arch vessel stumps). The patency and morphologic change of the false lumen of the arch vessels were evaluated using contrast-enhanced computed tomography. RESULTS: Overall, 2 hospital deaths were recorded, and the hospital mortality rate was 4%. No postoperative cerebral strokes and reoperations due to bleeding occurred. Follow-up by contrast-enhanced computed tomography was completed in 24 patients (37 stumps) with a mean duration of 99 ± 35 months. The postoperative closure rate of the false lumen after adventitial inversion was 86%, which was higher than when adventitial inversion was not used. No adverse events including stroke occurred during follow-up period. CONCLUSIONS: This technique facilitates the closure of the false lumen of dissected arch vessels and might improve clinical outcomes.

Intimal-protected adventitial inversion technique accelerates the obliteration of a patent false lumen.

BACKGROUND AND AIMS: The optimal procedure for reconstructing the dissected aortic stump for acute type A dissection remains controversial. We routinely used the intimal-protected adventitial inversion technique (iPAIT), a modified adventitial inversion technique, to protect the fragile intima by inserting a graft and assessed the safety and efficacy of this technique. METHODS: Between August 2008 and April 2020, 146 consecutive patients with acute type A dissections underwent thoracic aortic surgery in our hospital. Extended total aortic arch replacement was performed in 119 patients (81.5%). Sixty-nine patients underwent treatment for distal aortic anastomosis with the iPAIT. To compare the iPAIT to a historical control, we assessed 69 iPAIT patients and 25 patients who underwent total arch replacement using gelatin-resorcinol-formaldehyde (GRF) glue. RESULTS: Hospital mortality was 2.9% in the iPAIT group and 8.0% in the GRF group. Perioperative characteristics were similar between the two groups. However, postoperative computed tomography revealed that the obliteration rate was significantly higher in the iPAIT group (60/66, 90.9%) than in the GRF group (15/23, 65.2%) (p = .01), not including the patients who had died or developed severe renal dysfunction. The 8-year aortic event-free survival rate in the iPAIT group (81.3%) was significantly higher than that in the GRF group (47.4%). CONCLUSIONS: The use of this technique for acute type A dissections resulted in a low mortality rate and demonstrated promising midterm survival and may accelerate the obliteration of a patent false lumen and prevent late aortic events.

Feasibility of open chest management with modified negative pressure wound therapy immediately after cardiac surgery.

OBJECTIVES: To evaluate the feasibility of open chest management with our modified negative pressure wound therapy immediately after cardiac surgery as a therapy for atypical tamponade. METHODS: Open chest with modified negative pressure wound therapy was performed immediately after cardiac surgery. The surface of the heart and the vessels were covered with non-adherent siliconized gauze. The sternal halves were stented using edge-cut disposable syringes to maintain a larger mediastinal cavity. Approximately 45 mm of distance was kept between the sternal edges. A trimmed sterile polyvinyl foam sponge was inserted into the mediastinum, the entire wound was sealed and negative pressure (-50 to -75 mmHg) was applied using a suction generator. Delayed chest closure was performed in a standard manner once the haemodynamic status was stabilizsed. RESULTS: The mortality rate was 3/15 (20%) patients. Deep sternal wound infection occurred in 1/15 (6.7%) patients. Five patients were extubated during the open chest management. Sternal closure was delayed for median of 3 days after the initial surgery. There was no incidence of bleeding complications or need for additional haemostatic procedures. CONCLUSIONS: Negative pressure wound therapy performed immediately after cardiac surgery was feasible in our small number of patients. CLINICAL REGISTRATION NUMBER: Study ID: 2020-149.

Prevalence and prognosis of chronic fibrosing interstitial lung diseases with a progressive phenotype.

BACKGROUND AND OBJECTIVE: The development of clinically progressive fibrosis complicates a wide array of interstitial lung diseases (ILDs). However, there are limited data regarding its prevalence and prognosis. METHODS: We analysed consecutive patients seen for initial evaluation of a fibrosing form of ILD (FILD). Patients were evaluated for evidence of progressive fibrosis over the first 24 months of follow-up. We defined a progressive phenotype as the presence of at least one of the following: a relative decline in forced vital capacity (FVC) of ≥10%; a relative decline in FVC of ≥5%-<10% with a relative decline in diffusing capacity of the lung for carbon monoxide of ≥15%, increased fibrosis on HRCT or progressive symptoms. RESULTS: Eight hundred and forty-four patients (397 with idiopathic pulmonary fibrosis [IPF] and 447 non-IPF FILD) made up the final analysis cohort. Three hundred and fifty-five patients (42.1%) met the progressive phenotype criteria (59.4% of IPF patients and 26.6% of non-IPF FILD patients, p <0.01). In both IPF and non-IPF FILD, transplantation-free survival differed between patients with a progressive phenotype and those without (p <0.01). Multivariable analysis showed that a progressive phenotype was an independent predictor of transplantation-free survival (hazard ratio [HR]: 3.36, 95% CI: 2.68-4.23, p <0.01). Transplantation-free survival did not differ between non-IPF FILD with a progressive phenotype and IPF (HR: 1.12, 95% CI: 0.85-1.48, p = 0.42). CONCLUSION: Over one-fourth of non-IPF FILD patients develop a progressive phenotype compared to approximately 60% of IPF patients. The survival of non-IPF FILD patients with a progressive phenotype is similar to IPF.

Weekly nanoparticle albumin-bound paclitaxel and paclitaxel for relapsed small cell lung cancer: A retrospective observational study.

ABSTRACT: In addition to advanced non-small cell lung cancer, nanoparticle albumin-bound paclitaxel (nab-PTX) may also harbor potential benefit for patients with relapsed small cell lung cancer (SCLC), since weekly paclitaxel (PTX) shows modest activity for relapsed SCLC. We evaluated the efficacy and safety of both weekly nab-PTX and PTX for relapsed SCLC.We retrospectively reviewed 52 consecutive relapsed SCLC patients who were treated with weekly nab-PTX or PTX at our hospital.The response rate, median progression-free survival and overall survival with nab-PTX and PTX were 5.6 vs 8.8%, 3.2 vs 1.7 months, and 5.4 vs 4.5 months, respectively. No statistically significant differences were observed. There was no statistical difference between the 2 groups for ≥Grade 3 adverse events.Weekly nab-PTX and PTX showed similar activity for relapsed SCLC. The toxicity profile of nab-PTX was equally tolerable to that of PTX.

Effectiveness of monoclonal antibody therapy for COVID-19 patients using a risk scoring system.

INTRODUCTION: Monoclonal antibody therapy has been reported to be highly effective for preventing hospitalisation and severe cases in patients with Coronavirus Disease 2019 (COVID-19). However, since the drug is not readily available, it is important to rapidly and appropriately identify high-risk patients who can benefit most from therapy. Therefore, we designed a risk scoring system to identify at-risk COVID-19 patients in our region during the largest surge of COVID-19, from July to September 2021. METHODS: According to the risk scores, confirmed COVID-19 patients were introduced to receive REGN-CoV-2 to our hospital by regional health centre from 18th August (Term 3). The primary outcome was the comparison of the number of hospitalisation and severe condition with other periods, the 4th wave (Term 1) and the early part of the 5th wave (Term 2) in Japan. RESULTS: During Term 3, 115 patients were stratified with the scoring system and administered REGN-COV-2. The number of hospitalisation vs severe cases were 60 (5.2%) vs 14 (1.2%), 8 (1.5%) vs 3 (0.6%) and 21 (1.2%) vs 2 (0.1%), in term 1, 2 and 3, respectively. Among those aged <60 years, compared with term 1, the relative risk of hospitalisation and severe condition were 0.25 (95% CI: 0.12-0.53) and 0.10 (95% CI: 0.01-0.80), respectively, in term 3. Drug adverse events were fever (3: 2.6%), headache (1: 0.9%) and neck rash (1: 0.9%), all events were resolved within 24 h wth no serious adverse event. CONCLUSIONS: The administration of monoclonal antibody therapy using a risk scoring system significantly reduced the number of hospitalisation and disease severity of COVID-19 without any serious adverse events and avoided regional medical collapse.