Annals of the American Thoracic Society
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Rationale: Many clinical studies have focused on the epidemiological and clinical characteristics of inpatients with coronavirus disease (COVID-19). However, there are few reports about the clinical follow-up of discharged patients. Objectives: To describe the follow-up of patients with COVID-19 in Wenzhou City, Zhejiang, China. ⋯ The lung damage was fully absorbed in 55.6% of discharged patients with recurrence of positive test results for SARS-CoV-2 ribonucleic acid. Conclusions: The lung damage due to COVID-19 could be reversible for patients with common COVID-19. A few cases showed recurring positive results of nucleic-acid tests after discharge.
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Randomized Controlled Trial Multicenter Study
Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.
The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including 1) widespread, off-label use of the study drug before the availability of safety and efficacy data; 2) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic; 3) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment; 4) obtaining indistinguishable drug and placebo without delaying enrollment; and 5) rapidly obtaining administrative and regulatory approvals. ⋯ We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults. Clinical trial registered with www.clinicaltrials.gov (NCT04332991).
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During the ongoing coronavirus disease (COVID-19) pandemic, reports in social media and the lay press indicate that a subset of patients are presenting with severe hypoxemia in the absence of dyspnea, a problem unofficially referred to as "silent hypoxemia." To decrease the risk of complications in such patients, one proposed solution has been to have those diagnosed with COVID-19 but not sick enough to warrant admission monitor their arterial oxygenation by pulse oximetry at home and present for care when they show evidence of hypoxemia. Though the ease of use and low cost of pulse oximetry makes this an attractive option for identifying problems at an early stage, there are important considerations with pulse oximetry about which patients and providers may not be aware that can interfere with successful implementation of such monitoring programs. ⋯ There are also multiple sources of error in pulse oximetry that must be accounted for, including rapid fluctuations in measurements when the arterial oxygen pressure/tension falls on the steep portion of the dissociation curve, data acquisition problems when pulsatile blood flow is diminished, accuracy in the setting of severe hypoxemia, dyshemoglobinemias, and other problems. Recognition of these issues and careful counseling of patients about the proper means for measuring their oxygen saturation and when to seek assistance can help ensure successful implementation of needed monitoring programs.
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Multicenter Study Comparative Study Observational Study
Comparison of Multiple Breath Washout and Spirometry in Children with Primary Ciliary Dyskinesia and Cystic Fibrosis and Healthy Controls.
Rationale: In cystic fibrosis (CF), the lung clearance index (LCI), derived from multiple breath washout (MBW), is more sensitive in detecting early lung disease than FEV1; MBW has been less thoroughly evaluated in young patients with primary ciliary dyskinesia (PCD). Objectives: Our objectives were 1) to evaluate the sensitivity of MBW and spirometry for the detection of mild lung disease in young children with PCD and CF compared with healthy control (HC) subjects and 2) to compare patterns of airway obstruction between disease populations. Methods: We used a multicenter, single-visit, observational study in children with PCD and CF with a forced expiratory volume in 1 second (FEV1) greater than 60% predicted and HC subjects, ages 3-12 years. ⋯ LCI did not correlate with FEV1. Conclusions: The LCI is more sensitive than FEV1 in detecting lung disease in young patients with PCD, similar to CF. LCI holds promise as a sensitive endpoint for the assessment of early PCD lung disease.