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Trials ; 23(1): 927, 2022 Nov 08.
Article in English | MEDLINE | ID: covidwho-2108880


The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and implement new strategies and solutions to mitigate its negative impact on the progress of clinical trials. In this paper, we describe the challenges, strategies, and lessons learned regarding the continuation of a supportive oncology clinical trial during the pandemic. We hope to provide insight into the implementation of clinical trials during a public health emergency to be better prepared for future instances.Trial registration:, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

COVID-19 , Neoplasms , Humans , Pandemics , SARS-CoV-2 , Medical Oncology , Neoplasms/therapy
Int J Med Sci ; 18(5): 1277-1284, 2021.
Article in English | MEDLINE | ID: covidwho-1060234


Rationale: To assess the longitudinal changes and relationships of clinical measures and extent of CT lung abnormalities in COVID-19. Methods: 81 patients with COVID-19 were prospectively enrolled and followed until discharge. CT scores were quantified on a basis of a CT scoring system where each lung was divided into 3 zones: upper (above the carina), middle, and lower (below the inferior pulmonary vein) zones; each zone was evaluated for percentage of lung involvement on a scale of 0-4 (0, 0%; 1, 0-24%; 2, 25% - 49%; 3, 50% -74%; 4, >74%).Temporal trends of CT scores and the laboratory parameters characteristic of COVID-19 were analyzed. Correlations between the two were determined at three milestones (initial presentation, worst CT manifestation, and recovery finding before discharge). Their correlations with duration to worst CT manifestation and discharge from symptom onset were evaluated. Results: CT scores peaked during illness days 6-11 (median: 5), and stayed steady. C-reactive protein and lactate dehydrogenase increased, peaked on illness days 6-8 and 8-11 (mean: 23.5 mg/L, 259.9 U/L), and gradually declined. Continual decrease and increase were observed in hemoglobin and lymphocyte count, respectively. Albumin reduced and remained at low levels with a nadir on illness days 12-15 (36.6 g/L). Both initial (r = 0.58, 0.64, p < 0.05) and worst CT scores (r = 0.47, 0.65, p < 0.05) were correlated with C-reactive protein and lactate dehydrogenase; and CT scores before discharge, only with albumin (r = -0.41, p < 0.05). Duration to worst CT manifestation was associated with initial and worst CT scores (r = 0.33, 0.29, p < 0.05). No parameters were related to timespan to discharge. Conclusion: Our results illustrated the temporal changes of characteristic clinical measures and extent of CT lung abnormalities in COVID-19. CT scores correlated with some important laboratory parameters, and might serve as prognostic factors.

COVID-19/diagnostic imaging , Lung/diagnostic imaging , Adult , C-Reactive Protein/metabolism , COVID-19/blood , Female , Humans , L-Lactate Dehydrogenase/blood , Longitudinal Studies , Male , Middle Aged , Prospective Studies , Radiography, Thoracic , Tomography, X-Ray Computed
Head Neck ; 42(7): 1507-1515, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-614117


INTRODUCTION: The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has altered the health care environment for the management of head and neck cancers. The purpose of these guidelines is to provide direction during the pandemic for rational Head and Neck Cancer management in order to achieve a medically and ethically appropriate balance of risks and benefits. METHODS: Creation of consensus document. RESULTS: The process yielded a consensus statement among a wide range of practitioners involved in the management of patients with head and neck cancer in a multihospital tertiary care health system. CONCLUSIONS: These guidelines support an ethical approach for the management of head and neck cancers during the COVID-19 epidemic consistent with both the local standard of care as well as the head and neck oncological literature.

Betacoronavirus , Coronavirus Infections/prevention & control , Head and Neck Neoplasms/therapy , Infection Control/standards , Medical Oncology/standards , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Ambulatory Care/standards , COVID-19 , Combined Modality Therapy , Continuity of Patient Care/standards , Coronavirus Infections/diagnosis , Head and Neck Neoplasms/diagnosis , Humans , Multi-Institutional Systems , Otorhinolaryngologic Surgical Procedures/standards , Palliative Care/standards , Patient Safety , Pennsylvania , Personal Protective Equipment , Pneumonia, Viral/diagnosis , SARS-CoV-2 , Terminal Care/standards , Tertiary Care Centers