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1.
Int Forum Allergy Rhinol ; 2022 Jan 18.
Article in English | MEDLINE | ID: covidwho-1625163

ABSTRACT

BACKGROUND: The nose is the portal for SARS-CoV-2 infection, suggesting the nose as a target for topical antiviral therapies. The purpose of this study was to assess both the in vivo and in vitro efficacy of a detergent-based virucidal agent, Johnson and Johnson's Baby Shampoo (J&J), in SARS-CoV-2 infected subjects. METHODS: Subjects were randomized into 3 treatment groups: 1)Twice daily nasal irrigation with J&J in hypertonic saline, 2)Hypertonic saline alone, and 3)No intervention. Complementary in vitro experiments were performed in cultured human nasal epithelia. The primary outcome measure in the clinical trial was change in SARS-CoV-2 viral load over 21 days. Secondary outcomes included symptom scores and change in daily temperature. Outcome measures for in vitro studies included change in viral titers. RESULTS: 72 subjects completed the clinical study (n = 24 per group). Despite demonstrated safety and robust efficacy in in vitro virucidal assays, J&J irrigations had no impact on viral titers or symptom scores in treated subjects relative to controls. Similar findings were observed administering J&J to infected cultured human airway epithelia using protocols mimicking the clinical trial regimen. Additional studies of cultured human nasal epithelia demonstrated that lack of efficacy reflected pharmacokinetic failure, with the most virucidal J&J detergent components rapidly absorbed from nasal surfaces. CONCLUSIONS: In this randomized clinical trial of subjects with SARS-CoV-2 infection, a topical detergent-based virucidal agent had no effect on viral load or symptom scores. Complementary in vitro studies confirmed a lack of efficacy, reflective of pharmacokinetic failure and rapid absorption from nasal surfaces. This article is protected by copyright. All rights reserved.

2.
J Emerg Crit Care Med ; 52021 Jan.
Article in English | MEDLINE | ID: covidwho-1285625

ABSTRACT

Background: The COVID-19 pandemic has overwhelmed hospital systems in multiple countries and necessitated caring for patients in atypical healthcare settings. The goal of this study was to ascertain if the conventional critical care severity scores qSOFA, SOFA, APACHE-II, and SAPS-II could predict which patients admitted to the hospital from an emergency department would eventually require intensive care. Methods: This single-center, retrospective cohort study enrolled patients admitted to Vanderbilt University Hospital from the emergency room with symptomatic, confirmed COVID-19 infection between March 8, 2020 through May 15, 2020. Clinical phenotyping was performed by chart abstraction, and the correlation of the qSOFA, SOFA, APACHE-II, and SAPS-II scores for the primary endpoint of ICU admission and secondary endpoint of in-hospital mortality was evaluated. Results: During the study period, 128 patients were admitted to Vanderbilt University Hospital from the emergency room with COVID-19. Of these, 39 patients eventually required intensive care; the remaining 89 were discharged from the medical ward. All severity of illness scores demonstrated at least moderate ability to identify patients who would die or require ICU admission. Of the three severity of illness scores assessed, the APACHE-II score performed best with an AUC of 0.851 (95% CI: 0.786 to 0.917) for identifying patient that would require ICU admission. No patient with an APACHE-II score at the time of presentation less than 8 or qSOFA of 0 required intensive care unit (ICU) admission. All patients with an APACHE-II score less than 10 or qSOFA score of 0 survived to hospital discharge. Conclusions: The APACHE-II score accurately predicts the eventual need for ICU admission. This may allow for risk-stratification of patients safe to treat in alternative health care settings and prognostic enrichment to accelerate clinical trials of COVID-19 therapies.

3.
Res Sq ; 2021 May 14.
Article in English | MEDLINE | ID: covidwho-1237042

ABSTRACT

The nose is the portal for SARS-CoV-2 infection, suggesting the nose as a target for topical antiviral therapies. Because detergents are virucidal, Johnson and Johnson's Baby Shampoo (J&J) was tested as a topical virucidal agent in SARS-CoV-2 infected subjects. Twice daily irrigation of J&J in hypertonic saline, hypertonic saline alone, or no intervention were compared (n = 24/group). Despite demonstrated safety and robust efficacy in in vitro virucidal assays, J&J irrigations had no impact on viral titers or symptom scores in treated subjects relative to controls. Similar findings were observed administering J&J to infected cultured human airway epithelia using protocols mimicking the clinical trial regimen. Additional studies of cultured human nasal epithelia demonstrated that lack of efficacy reflected pharmacokinetic failure, with the most virucidal J&J detergent components rapidly absorbed from nasal surfaces. This study emphasizes the need to assess the pharmacokinetic characteristics of virucidal agents on airway surfaces to guide clinical trials.

6.
Lancet Oncol ; 21(7): 914-922, 2020 07.
Article in English | MEDLINE | ID: covidwho-597772

ABSTRACT

BACKGROUND: Early reports on patients with cancer and COVID-19 have suggested a high mortality rate compared with the general population. Patients with thoracic malignancies are thought to be particularly susceptible to COVID-19 given their older age, smoking habits, and pre-existing cardiopulmonary comorbidities, in addition to cancer treatments. We aimed to study the effect of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on patients with thoracic malignancies. METHODS: The Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry is a multicentre observational study composed of a cross-sectional component and a longitudinal cohort component. Eligibility criteria were the presence of any thoracic cancer (non-small-cell lung cancer [NSCLC], small-cell lung cancer, mesothelioma, thymic epithelial tumours, and other pulmonary neuroendocrine neoplasms) and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms. Patients of any age, sex, histology, or stage were considered eligible, including those in active treatment and clinical follow-up. Clinical data were extracted from medical records of consecutive patients from Jan 1, 2020, and will be collected until the end of pandemic declared by WHO. Data on demographics, oncological history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes were collected. Associations between demographic or clinical characteristics and outcomes were measured with odds ratios (ORs) with 95% CIs using univariable and multivariable logistic regression, with sex, age, smoking status, hypertension, and chronic obstructive pulmonary disease included in multivariable analysis. This is a preliminary analysis of the first 200 patients. The registry continues to accept new sites and patient data. FINDINGS: Between March 26 and April 12, 2020, 200 patients with COVID-19 and thoracic cancers from eight countries were identified and included in the TERAVOLT registry; median age was 68·0 years (61·8-75·0) and the majority had an Eastern Cooperative Oncology Group performance status of 0-1 (142 [72%] of 196 patients), were current or former smokers (159 [81%] of 196), had non-small-cell lung cancer (151 [76%] of 200), and were on therapy at the time of COVID-19 diagnosis (147 [74%] of 199), with 112 (57%) of 197 on first-line treatment. 152 (76%) patients were hospitalised and 66 (33%) died. 13 (10%) of 134 patients who met criteria for ICU admission were admitted to ICU; the remaining 121 were hospitalised, but were not admitted to ICU. Univariable analyses revealed that being older than 65 years (OR 1·88, 95% 1·00-3·62), being a current or former smoker (4·24, 1·70-12·95), receiving treatment with chemotherapy alone (2·54, 1·09-6·11), and the presence of any comorbidities (2·65, 1·09-7·46) were associated with increased risk of death. However, in multivariable analysis, only smoking history (OR 3·18, 95% CI 1·11-9·06) was associated with increased risk of death. INTERPRETATION: With an ongoing global pandemic of COVID-19, our data suggest high mortality and low admission to intensive care in patients with thoracic cancer. Whether mortality could be reduced with treatment in intensive care remains to be determined. With improved cancer therapeutic options, access to intensive care should be discussed in a multidisciplinary setting based on cancer specific mortality and patients' preference. FUNDING: None.


Subject(s)
Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Registries/statistics & numerical data , Thoracic Neoplasms/epidemiology , Aged , Betacoronavirus , COVID-19 , Cause of Death , Coronavirus Infections/mortality , Coronavirus Infections/pathology , Cross-Sectional Studies , Female , Hospitalization/statistics & numerical data , Humans , Longitudinal Studies , Male , Middle Aged , Pandemics , Pneumonia, Viral/mortality , Pneumonia, Viral/pathology , Risk Factors , SARS-CoV-2 , Thoracic Neoplasms/mortality , Thoracic Neoplasms/pathology , Thoracic Neoplasms/therapy
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