Efficacy and safety of single-dose ivermectin in mild-to-moderate COVID-19: the double-blind, randomized, placebo-controlled CORVETTE-01 trial.

Background: To investigate whether ivermectin inhibits SARS-CoV-2 proliferation in patients with mild-to-moderate COVID-19 using time to a negative COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) test. Methods: CORVETTE-01 was a double-blind, randomized, placebo-controlled study (August 2020-October 2021) conducted in Japan. Overall, 248 patients diagnosed with COVID-19 using RT-PCR were assessed for eligibility. A single oral dose of ivermectin (200 µg/kg) or placebo was administered under fasting. The primary outcome was time to a negative COVID-19 RT-PCR test result for SARS-CoV-2 nucleic acid, assessed using stratified log-rank test and Cox regression models. Results: Overall, 112 and 109 patients were randomized to ivermectin and placebo, respectively; 106 patients from each group were included in the full analysis set (male [%], mean age: 68.9%, 47.9 years [ivermectin]; 62.3%, 47.5 years [placebo]). No significant difference was observed in the occurrence of negative RT-PCR tests between the groups (hazard ratio, 0.96; 95% confidence interval [CI] 0.70-1.32; p = 0.785). Median (95% CI) time to a negative RT-PCR test was 14.0 (13.0-16.0) and 14.0 (12.0-16.0) days for ivermectin and placebo, respectively; 82.1% and 84% of patients achieved negative RT-PCR tests, respectively. Conclusion: In patients with COVID-19, single-dose ivermectin was ineffective in decreasing the time to a negative RT-PCR test. Clinical Trial Registration: ClinicalTrials.gov, NCT04703205.

Pre-Vaccination Anti-Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Seroprevalence in Workers at Three Japanese Hospitals.

BACKGROUND: Antibody testing is essential for accurately estimating the number of people infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to investigate the influence of background factors on seroprevalence by testing for anti-SARS-CoV-2 antibodies in blood samples obtained from the staff of three hospitals. METHODS: This cross-sectional observational study was conducted from June 8 to July 4, 2020, as part of a mandatory health examination. Leftover blood samples collected during the health examinations at each hospital were used to test for the presence of anti-SARS-CoV-2 antibodies. The Elecsys Anti-SARS-CoV-2 RUO assay was used for antibody detection. The relationship between staff age, gender, body mass index, blood pressure, work environments with different exposure risks, place of residence, and campus location and seroprevalence was investigated. The data were anonymized prior to analysis. RESULTS: A total of 3,677 individuals were included in the study, comprising 2,554 females (69.5%) and 1,123 males (30.5%). Anti-SARS-CoV-2 antibody (immunoglobulin G) was detected in 13 participants (0.35%). Seroprevalence was slightly higher in males than females (0.62% vs. 0.23%, P=0.08). By occupation, anti-SARS-CoV-2 antibodies were found in 6 (0.75%) physicians, 6 (0.31%) nurses, and one individual (0.11%) in the medical personnel group, with slightly higher levels in physicians. No significant difference was noted in the seroprevalence in terms of all background factors. CONCLUSIONS: Our study shows that the background factors do not impact seropositivity rates. Thorough daily infection control and adherence to recommended health guidelines were found to reduce infection risk.

Cross-sectional area of erector spinae muscles is associated with activities of daily living at discharge in middle- to older-aged patients with coronavirus disease 2019.

OBJECTIVES: Measurement of skeletal muscle wasting using computed tomography (CT) is widely known to be useful in predicting prognosis. Although some reports have been found in patients with coronavirus disease 2019 (COVID-19), few reports have focused on the ability to perform activities of daily living (ADLs). This study retrospectively investigated the relationship between the erector spinae muscle area measured from CT images and ADL at the time of hospital discharge in patients with COVID-19. METHODS: Among patients aged 40 years or older, 271 patients (median age, 65 years; 180/271 male patients) who had CT cross-sectional images of the 12th thoracic vertebral level on admission were included. The Katz index was used to assess ADLs, and patients who were not completely independent were defined as dependent. Multivariable logistic and Poisson regression analyses were applied to examine the relationship between the cross-sectional area of the erector spinae muscles and the onset of ADL dependence at discharge. RESULTS: A total of 75 (27.7%) patients became dependent on ADL at the time of hospital discharge. Decreased erector spinae muscle area was significantly related to dependent ADL at discharge (adjusted odds ratio: 0.886, 95% confidence interval: 0.805-0.975). In addition, the erector spinae muscle area was significantly related to the number of ADL items for which independence was not achieved (adjusted incidence rate ratio: 0.959, P < 0.001). CONCLUSIONS: The cross-sectional area of the erector spinae muscles from the thoracic CT image was associated with the ability to perform basic ADL at hospital discharge.

Clinical feasibility of remote intermittently scanned continuous glucose monitoring in coronavirus disease 2019 patients with and without diabetes during dexamethasone therapy.

The clinical utility of intermittently scanned continuous glucose monitoring (isCGM) in patients with coronavirus disease 2019 (COVID-19) is unclear. Hence, we investigated the accuracy of isCGM in COVID-19 patients during dexamethasone therapy. We evaluated the accuracy of the FreeStyle Libre via smartphone isCGM device compared to point-of-care (POC) fingerstick glucose level monitoring in 16 patients with COVID-19 (10 with and 6 without diabetes, 13 men; HbA1c 6.9 ± 1.0%). Overall, isCGM correlated well with POC measurements (46.2% and 53.8% within areas A and B of the Parkes error grid, respectively). The overall mean absolute relative difference (MARD) for isCGM compared to POC measurements was 19.4%. The MARDs were 19.8% and 19.7% for POC blood glucose measurements ranging from 70 to 180 mg/dL and >180 mg/dL, respectively. When divided according to the presence and absence of diabetes, both groups of paired glucose measurements showed a good correlation (56.3% and 43.7%, and 27.1% and 72.9% within the A and B areas in patients with and without diabetes, respectively), but the MARD was not significant but higher in patients without diabetes (16.5% and 24.2% in patients with and without diabetes). In conclusion, although isCGM may not be as accurate as traditional blood glucose monitoring, it has good reliability in COVID-19 patients with and without diabetes during dexamethasone therapy.

Tracheal Tube Obstruction Due to Hemoptysis Associated With Pulmonary Infarction in a Patient With Severe COVID-19 Pneumonia.

The incidence of thrombotic complications is extremely high among severe coronavirus disease 2019 (COVID-19) patients in the intensive care unit. Various factors such as a cytokine storm due to an excessive immune response to inflammation, hypoxemia, and disseminated intravascular coagulation are considered predisposing factors for thrombotic complications. A 55-year-old Japanese man intubated eight days previously was referred to our hospital because of a severe COVID-19 pneumonia diagnosis after his pharyngeal swab tested positive for severe acute respiratory syndrome coronavirus 2 using reverse transcription-polymerase chain reaction. The patient continued to remain hypoxic (PaO2/FiO2 ratio <100 mmHg) at the referring hospital. On admission, we initiated veno-venous extracorporeal membrane oxygenation (VV-ECMO). Unfractionated heparin and nafamostat mesylate were used as anticoagulants during VV-ECMO. Despite adequate anticoagulant therapy, he developed pulmonary infarction due to pulmonary embolism followed by hemoptysis. On day 10 following admission, his oxygen saturation dropped from 95% to 88%, with a marked decrease in his ventilator tidal volume, accompanied by an inability to ventilate the patient. Thereafter, we increased the VV-ECMO flow and exchanged his endotracheal tube. The lumen of the removed tracheal tube was found to be occluded by a large-sized blood coagulum. There was no further episode of tube occlusion. The patient was discharged in a walkable state on day 39 following admission. Endotracheal tube obstruction secondary to hemoptysis should be suggested in patients with COVID-19 requiring ventilator support, as they are unable to perform frequent endotracheal tube suctions owing to the risk of infection.

Clinical and Microbiological Features of Asymptomatic SARS-CoV-2 Infection and Mild COVID-19 in Seven Crewmembers of a Cruise Ship.

Objective To describe the clinical features and clinical course of individuals diagnosed with asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or mild coronavirus disease (COVID)-19. Patients The study participants consisted of 7 crewmembers of the passenger cruise-liner, Diamond Princess, who were admitted to our hospital after becoming infected with SARS-CoV-2 aboard the ship. Methods The data on patient background and biochemical test results were obtained from the patients' medical records. All patients had a chest X-ray, and a throat swab and sputum samples were sent for culture on admission. Results The median age of the 7 patients, of whom 4 were male and 3 were female, was 39 years (range: 23-47 years). On admission, none of them had fever, but 4 (57%) had a cough. None of them showed any signs of organ damage on laboratory testing. Chest X-ray showed pneumonia in one individual, which resolved spontaneously, while the other 6 had normal chest X-ray findings. Culture of throat swabs and sputum samples revealed that 4 patients (57%) had bacterial upper respiratory infections (Haemophilus influenzae, Klebsiella pneumoniae, and Staphylococcus aureus). The period from a positive polymerase chain reaction (PCR) test to negative conversion ranged from 5 to 13 days, with a median of 8 days. Conclusion Healthy young adults without risk factors who acquire SARS-CoV-2 infection may have an asymptomatic infection or may experience mild COVID-19. In addition to obesity, an older age, underlying illness, and being overweight can lead to a risk of exacerbation; thus, hospital management for such individuals may be desirable. Culturing respiratory samples may be useful for diagnosing secondary bacterial pneumonia.

First report in Japan of a delivery of a woman with the 2019 novel coronavirus disease.

On April 2, 2020, we received a maternal transport from a local city hospital of a pregnant woman (38 weeks and 0 days of gestation) in her 20s, who had the 2019 novel coronavirus disease (COVID-19). We performed an emergency cesarean section with spinal anesthesia because of an abnormal fetal heart rate pattern. A healthy 3106-g male baby was delivered. All the severe acute respiratory syndrome coronavirus 2 polymerase chain reaction tests of nasal and oral discharges, anal swabs and blood samples of the neonate at 9 h, 30 h and 4 days after birth were negative. Because the mother was diagnosed as having COVID-19 pneumonia, the neonate was given formula milk. The mother's nasal discharge samples at 20 and 21 days were negative. The mother first held her baby in her arms on the 22nd day after birth, and they were discharged on the following day. To the best of our knowledge, this is the first report in Japan of a delivery of a baby from a woman infected with COVID-19.

Pancreatitis in a Patient with Severe Coronavirus Disease Pneumonia Treated with Veno-venous Extracorporeal Membrane Oxygenation.

Severe coronavirus disease (COVID-19) can induce serious complications, including acute respiratory distress syndrome, septic shock, and acute kidney injury. However, few reports have associated COVID-19 with pancreatitis. We herein report the case of a 55-year-old patient who developed acute pancreatitis associated with severe COVID-19 pneumonia and was successfully treated with veno-venous extracorporeal membrane oxygenation (ECMO). Elevated pancreatic enzymes levels and computed tomography findings led to the diagnosis of acute pancreatitis due to COVID-19. Although we found that severe COVID-19 pneumonia can lead to pancreatitis, the underlying pathophysiology remains unknown.

Three Novel COVID-19 Pneumonia Cases Successfully Treated With Lopinavir/Ritonavir.

Following the first case of Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-Cov-2), in Wuhan, China, in December 2019, it has spread worldwide. An outbreak in Japan occurred on a cruise ship, and this was followed by community-acquired COVID-19. Herein, we report three cases of COVID-19 that presented pneumonia following admission to Kitasato University Hospital. Patients were admitted based on the positive result of real-time reverse transcriptase-polymerase chain reaction (RT-PCR) tests for COVID-19 nucleic acid. All patients were diagnosed as suffering from non-severe COVID-19 pneumonia and were successfully treated with Lopinavir/Ritonavir (LPV/r). LPV/r could be an option for treating non-severe COVID-19 pneumonia in general and even in elderly patients.