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.

Relationship between the spread of COVID-19, social frailty, and depressive symptoms in patients with heart failure.

In community-dwelling older people, coronavirus disease 2019 (COVID-19) has been reported to be associated with the development of frailty and depressive symptoms. We aimed to investigate whether the spread of COVID-19 is associated with the development of frailty in patients with heart failure (HF). The presence of the multi-domain of frailty in 257 patients with HF was assessed at hospital discharge. The spread of COVID-19 was significantly associated with the development of social frailty and depressive symptoms. Evaluation of these symptoms during hospitalization would support disease management and understanding of their social and psychological conditions.

Autopsy Case Report of Severe COVID-19 Pneumonia at a General Municipal Hospital.

We present the autopsy procedure and findings of severe coronavirus disease 2019 (COVID-19) pneumonia in an 85-year-old man. The patient required intubation immediately after admission for severe COVID-19 pneumonia. He had severe hypoxia that did not improve despite treatment with remdesivir, corticosteroids, and appropriate mechanical ventilation. On day 13, the patient developed sudden hypercapnia. His renal dysfunction subsequently worsened and became associated with hyperkalemia, and he passed away on day 15. An autopsy was performed to clarify the cause of the hypercapnic hypoxia. None of the medical personnel involved in the autopsy developed symptoms of COVID-19. Histologic examination showed various stages of diffuse alveolar damage throughout the lungs, with intra-alveolar hemorrhage in the upper zones. Microscopic examination of the kidneys revealed acute tubular necrosis. There was no significant systemic thrombosis. The autopsy findings were consistent with those typical of COVID-19.

Very late stent thrombosis lacking findings of the typical causes on optical coherence tomography in a patient with SARS-CoV-2☆

A 50-year-old male was admitted to our hospital with sudden-onset chest pain. He was a current smoker with severe obesity and diabetes. He had a history of drug-eluting stent (DES) implantation in the left anterior descending artery (LAD) and had continuously taken clopidogrel. Eight days prior to admission, polymerase chain reaction testing confirmed that he was positive for severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). Emergent coronary angiography revealed total occlusion of previously implanted DES in LAD. Optical coherence tomography (OCT) images demonstrated the presence of large white thrombus within the well-expanded DES with homogenous neointima. There were no findings of malapposed strut, uncovered strut, intimal disruption, or neoatherosclerosis through the stented segment. Subsequent dilation using a drug-coated balloon successfully restored coronary flow in LAD. We experienced a case of very late stent thrombosis without findings of the typical causes on OCT images nor discontinuation of antiplatelet therapy in a patient with SARS-CoV-2. The present case suggests that SARS-CoV-2 infection may induce stent thrombosis irrespective of the presence of known causes and the status of antiplatelet therapy. Learning objective The underlying causes of very late stent thrombosis (VLST) include strut malapposition, neoatherosclerosis, uncovered struts and stent underexpansion in addition to inadequate discontinuation of antiplatelet therapy and/or systemic hyper coagulable state. The present case of VLST lacking those factors suggests the enhanced hyper thrombogenicity irrespective of the presence of known causes and the status of antiplatelet therapy in patients with severe acute respiratory syndrome coronavirus type 2.

Usefulness of physical function sub-item of SF-36 survey to predict exercise intolerance in patients with heart failure.

BACKGROUND: Exercise intolerance is widely known to be a major cardinal symptom in patients with heart failure (HF), but due to the recent coronavirus disease 2019 epidemic, it is still difficult to directly measure exercise tolerance in many hospitals and facilities. The 36-Item Short-Form Health Survey physical functioning (SF-36PF) pertain to lower extremity functioning and walking. The purpose of this study was to investigate whether SF-36PF is a useful predictor of exercise intolerance and to provide its optimal cut-off value for patients with HF. METHODS AND RESULTS: SF-36PF and 6-min walking distance (6MWD) were evaluated in 372 consecutive patients with HF. Exercise intolerance was defined at 6MWD cut-offs of 200, 300, and 400 m. The addition of SF-36PF to the pre-existing determinants of exercise tolerance significantly improved the area under the curve scores (0.85 vs. 0.89, P = 0.011 for 6MWD <200 m; 0.90 vs. 0.93, P = 0.001 for 6MWD <300 m; 0.88 vs. 0.90, P = 0.021 for 6MWD <400 m) for the predictive effect on exercise intolerance. The cut-off values of SF-36PF for predicting exercise intolerance defined by 6MWD <200, 300, and 400 m were 45, 50, and 70, respectively. CONCLUSIONS: SF-36PF is a useful tool as an alternative index to predict exercise intolerance in patients with HF.