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1.
Circ J ; 2022 Jun 03.
Article in English | MEDLINE | ID: covidwho-1879294

ABSTRACT

BACKGROUND: The potential benefit of therapeutic-dose anticoagulation for critically ill patients with coronavirus disease 2019 (COVID-19) is still controversial.Methods and Results: In the CLOT-COVID study, 225 patients with severe COVID-19 on admission requiring mechanical ventilation or extracorporeal membrane oxygenation were divided into patients with therapeutic-dose anticoagulation (N=110) and those with prophylactic-dose anticoagulation (N=115). There was no significant difference in the incidence of thrombosis between the groups (9.1% vs. 7.8%, P=0.73). CONCLUSIONS: Among a cohort of critically ill patients with COVID-19, approximately half received therapeutic-dose anticoagulation, although it did not show a potential benefit compared with prophylactic-dose anticoagulation.

2.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-335470

ABSTRACT

Background: The coronavirus disease 2019 (COVID-19) causes extensive coagulopathy and a potential benefit of anticoagulation therapy has been documented for prevention of thromboembolic events. Bleeding events has also been reported as a notable complication;whereas, the incidence, risks, and clinical impact of bleeding remain unclear. Method: The CLOT-COVID Study was a nationwide, retrospective, multicenter cohort study on consecutive hospitalized patients with COVID-19 in Japan between April 2021 and September 2021. In this sub-analysis, we compared the characteristics of patients with and without major bleeding;moreover, we examined the risk factors for and clinical impact of bleeding events. Results: : Among 2882 patients with COVID-19, 57 (2.0%) had major bleeding. The incidence of major bleeding increased with COVID-19 severity as follows: 0.5%, 2.3%, and 12.3% in patients with mild, moderate, and severe COVID-19, respectively. COVID-19 severity, history of major bleeding, and anticoagulant type/dose were independently and additively associated with the bleeding incidence. Compared with patients without major bleeding, those with major bleeding exhibited a longer duration of hospitalization (9 [6-14] vs 28 [19-43] days, P<0.001) and higher mortality during hospitalization (4.9% vs. 35.1%, P<0.001). Conclusions: : In the real-world clinical practice, the incidence of major bleeding was not uncommon, especially in patients with severe COVID-19. Independent risk factors for major bleeding included history of major bleeding, COVID-19 severity, and anticoagulant use, which could be associated with poor clinical outcomes including higher mortality. Precise recognition of the risks for bleeding may be helpful for an optimal use of anticoagulants and for better outcomes in patients with COVID-19.

3.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-335438

ABSTRACT

Background: Although immunomodulators (tocilizumab or baricitinib) have been shown to improve outcomes in patients with coronavirus disease (COVID-19), the additive effect of remdesivir is unknown. We retrospectively tested the effect of remdesivir in combination with immunomodulators and standard treatments in COVID-19 patients. Methods: : A retrospective, single-center study was conducted on patients with COVID-19 admitted to the Hokkaido University Hospital between April 2020 and September 2021, who were treated with either tocilizumab or baricitinib. The duration to achievement of oxygen-free in both groups was compared, and the effect of remdesivir use on respiratory status was examined through multivariate analysis. The severity of respiratory status in the two groups on day 14 and day 28 was compared. A sensitivity analysis using propensity score was also performed. Results: : We enrolled 98 patients who received either tocilizumab or baricitinib. Of these, 72 patients used remdesivir (remdesivir group) and 26 did not (control group). Most cases were severe and treated with concomitant steroids. The remdesivir group had faster recovery of respiratory status compared to the control group (11 days vs. 26 days, P=0.033). Multivariate analysis showed that remdesivir use contributed to shorter time to being oxygen-free (hazard ratio [HR] = 2.33, 95 % confidence interval [CI] 1.17 – 4.46, P=0.016). Age, body mass index, diabetes mellitus, and time from onset to oxygen administration were independent prognostic factors. The remdesivir group achieved higher rate of oxygen free than the control group at days 14 and 28 after treatment (P=0.033, P=0.003, respectively). The degree of improvement from baseline severity was also higher in the remdesivir group (day 14;P=0.047, day 28;P=0.018). The survival time between two groups was not significantly different (HR = 0.55, 95 %CI 0.10 – 2.99, P=0.49). Similarly, the propensity score-matched patient groups showed the efficacy of remdesivir. Conclusions: : Among patients with COVID-19 who used immunomodulator containing tocilizumab or baricitiib, remdesivir contributed to shorter respiratory recovery time and better respiratory status at days 14 and 28. Concomitant use of remdesivir may contribute to improved respiratory status in patients on immunomodulator and standard treatment.

4.
Medicina (Kaunas) ; 58(4)2022 Apr 04.
Article in English | MEDLINE | ID: covidwho-1776285

ABSTRACT

Background and Objectives: Tocilizumab and baricitinib have been observed to improve the outcomes of patients with coronavirus disease 2019 (COVID-19). However, a comparative evaluation of these drugs has not been performed. Materials and Methods: A retrospective, single-center study was conducted using the data of COVID-19 patients admitted to Hokkaido University hospital between April 2020 and September 2021, who were treated with tocilizumab or baricitinib. The clinical characteristics of the patients who received tocilizumab were compared to those of patients who received baricitinib. Univariate and multivariate logistic regression analyses of the outcomes of all-cause mortality and improvement in respiratory status were performed. The development of secondary infection events was analyzed using the Kaplan-Meier method and the log-rank test. Results: Of the 459 patients hospitalized with COVID-19 during the study, 64 received tocilizumab treatment and 34 baricitinib treatment, and those 98 patients were included in the study. Most patients were treated with concomitant steroids and exhibited the same severity level at the initiation of drug treatment. When compared to each other, neither tocilizumab nor baricitinib use were associated with all-cause mortality or improvement in respiratory status within 28 days from drug administration. Conclusions: Age, chronic renal disease and early administration of TCZ or BRT from the onset of COVID-19 were independent prognostic factors for all-cause mortality, whereas anti-viral drug use and the severity of COVID-19 at baseline were associated with an improvement in respiratory status. Secondary infection-free survival rates of patients treated with tocilizumab and those treated with baricitinib did not significantly differ. The results suggest that both tocilizumab and baricitinib could be clinically equivalent agents of choice in treatment of COVID-19.


Subject(s)
COVID-19 , Antibodies, Monoclonal, Humanized , Azetidines , COVID-19/drug therapy , Humans , Purines , Pyrazoles , Retrospective Studies , Sulfonamides , Treatment Outcome
5.
J Cardiol ; 2022 Apr 05.
Article in English | MEDLINE | ID: covidwho-1773510

ABSTRACT

BACKGROUND: Data on thrombosis and current real-world management strategies for anticoagulation therapy are scarce but important for understanding current issues and unmet needs of an optimal management of patients with coronavirus disease 2019 (COVID-19). METHOD: The CLOT-COVID Study (thrombosis and antiCoaguLatiOn Therapy in patients with COVID-19 in Japan Study: UMIN000045800) was a retrospective, multicenter cohort study enrolling consecutive hospitalized patients with COVID-19 among 16 centers in Japan from April 2021 to September 2021, and we tried to capture the status of the patients in the fourth and fifth waves of the COVID-19 infections in Japan. We enrolled consecutive hospitalized patients who were diagnosed with COVID-19 and had a positive polymerase chain reaction test obtained from the hospital databases. RESULTS: Among 2894 patients with COVID-19, 1245 (43%) received pharmacological thromboprophylaxis. The proportion of pharmacological thromboprophylaxis increased according to the severity of the COVID-19 in 9.8% with mild COVID-19, 61% with moderate COVID-19, and 97% with severe COVID-19. The types and doses of anticoagulants varied widely across the participating centers. During the hospitalization, 38 patients (1.3%) and 126 (4.4%) underwent ultrasound examinations for the lower extremities and contrast-enhanced computed tomography examinations, respectively, and 55 (1.9%) developed thrombosis, mostly venous thromboembolism (71%). The incidence of thrombosis increased according to the severity of the COVID-19 in 0.2% with mild COVID-19, 1.4% with moderate COVID-19, and 9.5% with severe COVID-19. Major bleeding occurred in 57 patients (2.0%) and 158 (5.5%) died, and 81% of them were due to respiratory failure from COVID-19 pneumonia. CONCLUSIONS: In the present large-scale observational study, pharmacological thromboprophylaxis for hospitalized patients with COVID-19 was common especially in patients with severe COVID-19, and management strategies varied widely across the participating centers. The overall incidence of thrombosis was substantially low with an increased incidence according to the severity of the COVID-19.

6.
Circ Rep ; 4(5): 215-221, 2022 May 10.
Article in English | MEDLINE | ID: covidwho-1770601

ABSTRACT

Background: To date, there are no large-scale data on the association between D-dimer levels at admission and the occurrence of venous thromboembolism (VTE) in Japanese patients with coronavirus disease 2019 (COVID-19). Methods and Results: The CLOT-COVID study was a retrospective, multicenter cohort study enrolling consecutive hospitalized patients with COVID-19 across 16 centers in Japan from April 2021 to September 2021. Among 2,894 enrolled patients, 2,771 (96%) had D-dimer levels measured at admission. Patients were divided into 3 groups based on tertiles of D-dimer levels at admission (1st tertile, D-dimer ≤0.5 µg/mL, n=949; 2nd tertile, D-dimer 0.51-1.09 µg/mL, n=894; 3rd tertile, D-dimer ≥1.1 µg/mL, n=928). The higher the tertile group, the more severe the COVID-19 status at admission. The incidence of VTE during hospitalization was highest in the 3rd tertile group (1st tertile, 0.3%; 2nd tertile, 0.3%; 3rd tertile, 3.6%; P<0.001). Even after adjusting for confounders in the multivariable logistic regression model, the higher D-dimer levels in the 3rd tertile (≥1.1 µg/mL) were independently associated with a higher risk of VTE during hospitalization (adjusted odds ratio 4.83 [95% confidence interval 1.93-12.11; P<0.001]; reference=1st tertile). Conclusions: Higher D-dimer levels at admission were associated with a higher risk of VTE events during hospitalization in Japanese patients with COVID-19. This could be helpful in determining patient-specific anticoagulation management strategies for COVID-19 in Japan.

7.
Thromb Res ; 213: 173-178, 2022 05.
Article in English | MEDLINE | ID: covidwho-1768565

ABSTRACT

INTRODUCTION: There has been limited data on the influence of sex on development of thrombosis in patients with coronavirus disease 2019 (COVID-19). MATERIALS AND METHODS: The CLOT-COVID Study was a retrospective, multicenter cohort study enrolling 2894 consecutive hospitalized patients with COVID-19 among 16 centers in Japan from April 2021 to September 2021. We divided the entire cohort into the men (N = 1885) and women (N = 1009) groups. RESULTS: There were no significant differences in D-dimer levels at admission between men and women. Men had more severe status of the COVID-19 at admission compared with women (Mild: 57% versus 66%, Moderate: 34% versus 29%, and Severe: 9.1% versus 5.7%, P < 0.001). Men more often received pharmacological thromboprophylaxis than women (47% versus 35%, P < 0.001). During the hospitalization, men more often developed thrombosis than women (2.5% [95%CI, 1.9-3.3%] versus 0.8% [95%CI, 0.4-1.6%], P = 0.001). Men had numerically higher incidences of thrombosis than women in all subgroups of the worst severity of COVID-19 during the hospitalization (Mild: 0.3% versus 0.0%, Moderate: 1.6% versus 1.0%, and Severe: 11.1% versus 4.3%). Even after adjusting confounders in the multivariable logistic regression model, the excess risk of men relative to women remained significant for thrombosis (adjusted OR, 2.51; 95%CI, 1.16-5.43, P = 0.02). CONCLUSIONS: In the current large observational study of patients with COVID-19, men had more severe status of the COVID-19 than women, and the risk of development of thrombosis was higher in men compared with women, which could be helpful in determining the patient-specific optimal management strategies for COVID-19.


Subject(s)
COVID-19 , Thrombosis , Venous Thromboembolism , Anticoagulants/therapeutic use , COVID-19/complications , Cohort Studies , Female , Hospitalization , Humans , Male , Retrospective Studies , SARS-CoV-2 , Thrombosis/drug therapy , Venous Thromboembolism/drug therapy
8.
Intern Med ; 61(9): 1403-1410, 2022 May 01.
Article in English | MEDLINE | ID: covidwho-1725168

ABSTRACT

We present three cases with an atypical clinical course of organizing pneumonia (OP) secondary to coronavirus disease 2019 (COVID-19). Three patients were discharged with satisfactory improvement after standard steroid therapy for COVID-19. Shortly after the completion of treatment, the patients experienced a flare-up of symptoms. Imaging results showed new lesions in the lungs. Transbronchial lung cryobiopsy showed histological findings consistent with OP in all cases. Steroids were administered, and a good therapeutic response was observed. This report is the first to describe pathologically confirmed OP that developed after recovery from COVID-19. Careful follow-up is advisable for patients who have recovered from COVID-19.


Subject(s)
COVID-19 , Cryptogenic Organizing Pneumonia , Pneumonia , Cryptogenic Organizing Pneumonia/diagnosis , Humans , Lung/diagnostic imaging , Lung/pathology , Pneumonia/drug therapy
9.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-317708

ABSTRACT

Background: No clinical scoring system has yet been established to estimate the likelihood of COVID-19 and to determine the suitability of diagnostic testing in suspected COVID-19 patients. Methods: This was a single-center, retrospective, observational study of patients with suspected COVID-19 and confirmed COVID-19. Patient background, clinical course, laboratory and CT findings, and the presence of alternative diagnoses were evaluated. Clinical risk scores were developed based on clinical differences between patients with and those without COVID-19. Results: Among 110 patients suspected of COVID-19, 60.9% underwent PCR testing based on the judgment of physicians. Two patients were found to have COVID-19. The clinical characteristics of 108 non-COVID-19 patients were compared with those of 23 confirmed COVID-19 patients. Patients with COVID-19 were more likely to have a history of high-risk exposures and abnormal sense of taste and smell. Significantly higher rates of subnormal white blood cell count, lower eosinophil count, and lower procalcitonin level were observed in the COVID-19 group than in the non-COVID-19 group. When blood tests, CT findings, and the presence of alternative diagnoses were scored on an 11-point scale, i.e., “COVID-19 Clinical Risk Score”, the COVID-19 group scored significantly higher than the non-COVID-19 group, with more than four points in the COVID-19 group. All non-COVID cases that did not undergo PCR had a score of 4 or less. Conclusions: The COVID-19 Clinical Risk Score enables risk classification of patients suspected of having COVID-19 and can help in decision-making in clinical practice, including appropriateness of diagnostic testing.

10.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-296763

ABSTRACT

Summary Background Although biological agents, tocilizumab and baricitinib, have been shown to improve the outcomes of patients with COVID-19, a comparative evaluation has not been performed. Methods A retrospective, single-center study was conducted using the data of patients with COVID-19 admitted to the Hokkaido University hospital between April 2020 and September 2021, who were treated with tocilizumab or baricitinib. The clinical characteristics of patients who received each drug were compared. Univariate and multivariate logistic regression models were performed against the outcomes of all-cause mortality and the improvement in respiratory status. The development of secondary infection events was analyzed using the Kaplan–Meier analysis and the log-rank test. Results The use of tocilizumab or baricitinib was not associated with all-cause mortality and the improvement in respiratory status within 28 days of drug administration. Age, chronic renal disease, and comorbid respiratory disease were independent prognostic factors for all-cause mortality, while anti-viral drug use and severity of COVID-19 at baseline were associated with the improvement in respiratory status. There was no significant difference in the infection-free survival between patients treated with tocilizumab and those with baricitinib. Conclusion There were no differences in efficacy and safety between tocilizumab and baricitinib for the treatment of COVID-19.

13.
Endocr J ; 68(4): 477-484, 2021 Apr 28.
Article in English | MEDLINE | ID: covidwho-1204140

ABSTRACT

We provide the details of the successful management of a patient with active Cushing's disease complicated with coronavirus disease 2019 (COVID-19) pneumonia. The patient was a 27-year-old Japanese female healthcare worker who was scheduled to undergo pituitary surgery for Cushing's disease. She had been in close contact with an undiagnosed patient infected with COVID-19 and then developed COVID-19 pneumonia. Despite a lack of known risk factors associated with severe COVID-19 infection, the patient's dyspnea worsened and her respiratory condition deteriorated, as indicated by the need for 7 L/min oxygen supply by mask to maintain her oxygen saturation at >90%. Medical treatment was initiated to control hypercortisolism by the 'block and replace' regimen using steroidogenesis inhibitors and hydrocortisone. The COVID-19 pneumonia improved with multi-modal treatment including antiviral therapy. One month later, after a negative severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) test result and with appropriate protection against virus transmission to medical staff in the operating room and daily medical care nurses, trans-sphenoidal surgery was performed by our highly experienced pituitary surgeon. One month after the surgery, the patient's basal ACTH and cortisol levels and urinary free cortisol were all under the detection limit. Surgical remission was expected. Since hypercortisolism due to active Cushing's disease may worsen a COVID-19 infection, multi-disciplinary management that includes appropriate and prompt treatment strategies is mandatory in such cases.


Subject(s)
Amides/administration & dosage , Benzamidines/administration & dosage , COVID-19/therapy , Guanidines/administration & dosage , Metyrapone/administration & dosage , Pituitary ACTH Hypersecretion/therapy , Pregnenediones/administration & dosage , Pyrazines/administration & dosage , ACTH-Secreting Pituitary Adenoma/complications , ACTH-Secreting Pituitary Adenoma/drug therapy , Adenoma/complications , Adenoma/drug therapy , Adult , COVID-19/complications , COVID-19/pathology , Combined Modality Therapy , Dihydrotestosterone/administration & dosage , Dihydrotestosterone/analogs & derivatives , Disease Progression , Female , Health Personnel , Heparin/administration & dosage , Humans , Japan , Neurosurgical Procedures , Pituitary ACTH Hypersecretion/blood , Pituitary ACTH Hypersecretion/complications , Pituitary ACTH Hypersecretion/pathology , SARS-CoV-2/physiology , Treatment Outcome , Trimethoprim, Sulfamethoxazole Drug Combination/administration & dosage
14.
BMC Infect Dis ; 20(1): 858, 2020 Nov 18.
Article in English | MEDLINE | ID: covidwho-934259

ABSTRACT

BACKGROUND: No clinical scoring system has yet been established to estimate the likelihood of coronavirus disease (COVID-19) and determine the suitability of diagnostic testing in suspected COVID-19 patients. METHODS: This was a single-center, retrospective, observational study of patients with suspected COVID-19 and confirmed COVID-19. Patient background, clinical course, laboratory and computed tomography (CT) findings, and the presence of alternative diagnoses were evaluated. Clinical risk scores were developed based on clinical differences between patients with and without COVID-19. RESULTS: Among 110 patients suspected of having COVID-19, 60.9% underwent polymerase chain reaction (PCR) testing based on the judgment of physicians. Two patients were found to have COVID-19. The clinical characteristics of 108 non-COVID-19 patients were compared with those of 23 confirmed COVID-19 patients. Patients with COVID-19 were more likely to have a history of high-risk exposures and an abnormal sense of taste and smell. The COVID-19 group had significantly higher rates of subnormal white blood cell counts, lower eosinophil counts, and lower procalcitonin levels than the non-COVID-19 group. When blood test results, CT findings, and the presence of alternative diagnoses were scored on an 11-point scale (i.e., "COVID-19 Clinical Risk Score"), the COVID-19 group scored significantly higher than the non-COVID-19 group, more than four points in the COVID-19 group. All non-COVID patients who did not undergo PCR had a score of 4 or less. CONCLUSIONS: The COVID-19 Clinical Risk Score may enable the risk classification of patients suspected of having COVID-19 and can help in decision-making in clinical practice, including appropriateness of diagnostic testing. Further studies and prospective validation with an increased sample size are required.


Subject(s)
COVID-19 Testing , COVID-19/diagnosis , Research Design , SARS-CoV-2/genetics , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/virology , Case-Control Studies , Female , Humans , Japan/epidemiology , Leukocyte Count , Male , Middle Aged , Polymerase Chain Reaction/methods , Procalcitonin/blood , Retrospective Studies , Risk Assessment/methods , Tomography, X-Ray Computed/methods , Young Adult
15.
Respir Med Case Rep ; 31: 101295, 2020.
Article in English | MEDLINE | ID: covidwho-933463

ABSTRACT

We report a case of clinically diagnosed secondary organizing pneumonia (SOP) associated with coronavirus disease 2019 (COVID-19). A 70-year-old woman who had been diagnosed with COVID-19 was admitted to Hokkaido University Hospital. Although her fever, cough, dyspnea, and serum C-reactive protein levels improved, she developed rapidly progressive respiratory failure and computed tomography revealed the development of bilateral lung consolidation. Her dyspnea was relieved, and her oxygenation levels and radiological findings improved after commencing corticosteroid treatment. Blood biomarkers for interstitial lung disease, Krebs von den Lungen-6 (KL-6) and surfactant protein D (SP-D), showed different responses during the clinical course of her disease. Evaluation of serial changes in levels of KL-6 and SP-D may help diagnose and monitor COVID-19-associated organizing pneumonia (OP). Clinicians should be aware that SOP can develop in response to COVID-19 and that these patients may benefit from the use of steroids.

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