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MeSH Disease

Human Phenotype

Transmission

Seroprevalence
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    Hydroxychloroquine alone or in combination with azithromycin to prevent major clinical events in hospitalised patients with coronavirus infection MESHD (COVID-19): rationale and design of a randomised, controlled clinical trial

    Authors: Alexandre B Cavalcanti; Fernando G Zampieri; Luciani CP Azevedo; Regis G Rosa; Alvaro Avezum; Viviane C Veiga; Renato D Lopes; Leticia Kawano-Dourado; Lucas P Damiani; Adriano J Pereira; Ary Serpa Neto; Remo Furtado; Bruno Tomazini; Fernando A Bozza; Israel S Maia; Maicon Falavigna; Thiago C Lisboa; Henrique Fonseca; Flavia R Machado; Otavio Berwanger; COALITION COVID-19 Brazil I Investigators

    doi:10.1101/2020.05.19.20106997 Date: 2020-05-26 Source: medRxiv

    Introduction: Hydroxychloroquine and its combination with azithromycin have been suggested to improve viral clearance in patients with COVID-19, but its effect on clinical outcomes remains uncertain. Methods and analysis: We describe the rationale and design of an open-label pragmatic multicentre randomised (concealed) clinical trial of 7 days of hydroxychloroquine (400 mg BID) plus azithromycin (500 mg once daily), hydroxychloroquine 400 mg BID, or standard of care for moderately severe hospitalised patients with suspected or confirmed COVID-19 (in-patients with up to 4L/minute oxygen supply through nasal catheter). Patients are randomised in around 50 recruiting sites and we plan to enrol 630 patients with COVID-19. The primary endpoint is a 7-level ordinal scale measured at 15-days: 1)not hospitalised, without limitations on activities; 2)not hospitalised, with limitations on activities; 3)hospitalised, not using supplementary oxygen; 4)hospitalised, using supplementary oxygen; 5)hospitalised, using high-flow nasal cannula or non-invasive ventilation; 6)hospitalised, on mechanical ventilation; 7)death. Secondary endpoints are the ordinal scale at 7 days, need for mechanical ventilation and rescue therapies during 15 days, need of high-flow nasal cannula or non-invasive ventilation during 15 days, length of hospital stay, in-hospital mortality, thromboembolic MESHD events, occurrence of acute kidney injury HP acute kidney injury MESHD, and number of days free of respiratory support at 15 days. Secondary safety outcomes include prolongation of QT interval MESHD on electrocardiogram, ventricular arrhythmias HP ventricular arrhythmias MESHD, and liver toxicity MESHD. The main analysis will consider all patients with confirmed COVID-19 in the groups they were randomly assigned. Ethics and dissemination: This study has been approved by Brazil's National Ethic Committee (CONEP) and National Health Surveillance Agency (ANVISA). An independent data monitoring committee will perform interim analyses and evaluate adverse events throughout the trial. Results will be submitted for publication after enrolment and follow-up are complete, as well as presented and reported to local health agencies. ClinicalTrials.gov identifier: NCT04322123

    Clinical features of critically ill MESHD patients with COVID-19 infection MESHD in China

    Authors: Bo Hu; Dawei Wang; Chang Hu; Ming Hu; Fangfang Zhu; Hui Xiang; Beilei Zhao; Xiaoyi Zhang; Kianoush B. Kashani; Zhiyong Peng

    doi:10.21203/rs.3.rs-16250/v1 Date: 2020-03-02 Source: ResearchSquare

    Importance: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections MESHD outbreak in China is now a global issue. There is only a limited understanding of the clinical characteristics of patients with SARS-CoV-2 infections MESHD is available.Objective:To describe the characteristics, management strategies, and outcomes of critically ill MESHD patients with SARS-CoV-2 infection MESHD.Design, Setting, and Patients: This is aretrospective, multi-center case series of 50 critically ill MESHD patients with confirmed SARS-CoV-2 infection MESHD who were admitted at Zhongnan Hospital of Wuhan University and Wuhan Pulmonary Hospital in Wuhan, China, from January 8 to February 9, 2020.Exposures:Documented Corona Virus Disease MESHD, 2019 (COVID-19).Main Outcome Measures: Demographic, clinical, laboratory, imaging data were collected along with management strategies, complications and outcomes of enrolled individuals. Results Fifty critically ill MESHD patients with SARS-CoV-2 infections MESHD were enrolled. Their median age TRANS was 62 (range, 29-92) [IQR,49.5-69.0] years, 68% were male TRANS, and 28 (56%) patients had comorbidities, the most common being hypertension HP hypertension MESHD. In this cohort, 20(40%) patients survived ,16(32%) patients died, and the rest remained hospitalized. The invasive mechanical ventilator was used in 36(72%) patients with 15(30%) of them requiring prone positioning, and 17(34%) switched to ECMO. The compliance scores of lungs (Cstat)on the day of ICU admission among survivors were higher than those in non-survivors [42.0(18.0-47.0), vs. 19.5(14.0-24.2), p=0.038].The blood SERO IL-6 levels and neutrophils counts at the first day of ICU admission were significantly higher in non-survivors compared to survivors [123.7(85.3-228.8), vs. 20.2(6.8-67.2) ng/ml, p=0.025 for IL-6, and 20.2(6.8-67.2) vs. 4.01(1.99-7.05) × 10⁹/L, p=0.02 for neutrophils counts].The heart rates, PaCO2, lung injury MESHD scale (LIS), and positive end-expiratory pressure levels were constantly higher for 10 days in non-survivors than those who survived (p<0.05). The frequency of vasopressor uses and neuromuscular blockers was higher in non-survivors from day 1 to day 10 compared to survivors (p<0.05). In the whole cohort, the most common complications were ARDS (97%), shock HP shock MESHD (44%), arrhythmia HP arrhythmia MESHD (38%), acute cardiac injury MESHD (26%), and acute kidney injury HP acute kidney injury MESHD (22%). A secondary bacterial infection MESHD was noted in 17(34%) patients. Univariate analysis indicated that lower lung complianceand higher neutrophil counts at the day of ICU admission were related to higher mortality (p-0.03, and 0.04, respectively)ConclusionWe demonstrated that SARS-CoV-2 infection MESHD-related critical illness predominantly affected old individuals with comorbidities and characterized by severe hypoxemic respiratory failure MESHD respiratory failure HP, often requiring prolonged mechanical ventilation and rescue therapies. Low lung compliance and persistently elevated PaCO2 indicated poor outcomes.

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MeSH Disease
Human Phenotype
Transmission
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