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1.
Annals of the Rheumatic Diseases ; 80(SUPPL 1):897-898, 2021.
Article in English | EMBASE | ID: covidwho-1358809

ABSTRACT

Background: COVID-19 pandemic is a global emergency which may overlap on the clinical and radiological scenario of ILD in SSc. In clinical practice, the striking similarities observed at computed tomography (CT) between the diseases make it difficult to distinguish a COVID-19 superinfection from a progression of SSc-ILD. Objectives: The aim of our study was to identify the main CT features that may help distinguishing SSc-ILD from COVID-19 pneumonia. Methods: 22 international readers were included and divided in the radiologist group (RAD) and non-radiologist group (nRAD). The RAD group included nonchest RAD and chest-RAD. A total of 99 patients, 52 with COVID-19 and 47 with SSc-ILD, were included in the study. Results: Fibrosis inside focal ground glass opacities (GGO) in the upper lobes;fibrosis in the lower lobe GGO;reticulations in lower lobes (especially if bilateral and symmetrical or associated with signs of fibrosis) were the CT parameters most frequently associated with SSc-ILD. The CT parameters most frequently associated with COVID-19 pneumonia were: consolidation (CONS) in the lower lobes, CONS with peripheral (both central/peripheral or patchy distributions), anterior and posterior CONS and rounded-shaped GGOs in the lower lobes. After multivariate analysis, the presence of CONS in the lower lobes (p <0.0001) and signs of fibrosis in GGO in the lower lobes (p <0.0001) remained independently associated with COVID-19 pneumonia or SSc-ILD, respectively. These two variables were combined in a predictive score which resulted positively associated with the COVID-19 diagnosis, with 96.1% sensitivity and 83.3% specificity: 3 different risk class for COVID-19 pneumonia may be identified: high risk for COVID-19 pneumonia (5-9 points);probable overlap COVID-19 pneumonia in SSc-ILD (4 points);low risk for COVID-19 pneumonia (0-3 points). Conclusion: The CT differential diagnosis between COVID-19 Pneumonia and SSc-ILD is possible and may be fostered in practice by the use of a radiological score. In the case where an overlap of both diseases is suspected, the presence of consolidation in the lower lobes may suggest a COVID-19 pneumonia while the presence of fibrosis inside GGO may indicate a SSc-ILD.

2.
American Journal of Respiratory and Critical Care Medicine ; 203(9), 2021.
Article in English | EMBASE | ID: covidwho-1277031

ABSTRACT

RATIONALE: Scleroderma Lung Study (SLS) II established mycophenolate mofetil (MMF) as an active therapy for scleroderma-related interstitial lung disease (SSc-ILD) and the need to consider background MMF in future study designs. SLS III envisioned combination therapy in which the rapid onset and anti-fibrotic effects of pirfenidone (PFD) would complement the delayed immunosuppressive/anti-inflammatory actions of MMF. However, the study design failed to adequately predict the impact from widespread use of MMF by community physicians or FDA approval of nintedanib (9/19) to slow pulmonary function decline in SSc-ILD. SLS III recruitment challenges and adaptive clinical trial modifications are presented. METHODS: SLS III is an investigator-initiated, multi-center, double-blind placebo-controlled Phase II clinical trial of PFD in SSc-ILD. 150 treatment-naive patients were to be randomized to PFD or placebo, along with initiating MMF, to determine the relative efficacy/safety of combination therapy to MMF alone. The primary endpoint is change from baseline in FVC-% predicted during the 18-month treatment. Three adaptations were implemented: relaxation of screening/entry criteria;expansion of participating clinical sites and enrollment period;and a shift in the target population to include those already receiving MMF. RESULTS: At study initiation (01/18), recruiting eligible treatment-naive patients was already identified as a challenge. The maximum allowed FVC-% at screening (80%) and minimum allowed DLCO-% at baseline (25%) were relaxed 5% to reduce screen failures. The definition of “treatmentnaive” was broadened to include <3 months of prior MMF without need for a washout. With the release of SENSCIS results (05/20), we increased the number of clinical sites and the recruitment period. However, the rapid adoption of MMF therapy as a community standard forced us to consider patients already on longer treatment with MMF. The time-dependent impact of prior MMF duration on treatment effect was explored using clinical trial simulations to assess study power (Fig 1) and prior MMF exposure stratified into groups (naïve;<3, >3-6 and >6-9 months). The data identified an acceptable power (0.80) if <50% of enrolled participants had prior MMF use and prior MMF exposure was capped at 6 months (i.e., 3 groups). Unfortunately, the impact from COVID-19 ultimately curtailed site expansion and led to a truncated recruiting period (10/1/2020). 51 participants were randomized (76% naive;14% <3 months MMF;10% >3-6 months MMF). CONCLUSIONS: The SLS III experience highlights challenges in designing treatment protocols for SSc-ILD and the application of background study data and clinical trial simulations to execute adaptive study changes. (Table Presented).

3.
Proc. - Int. Conf. Educ. Technol., ICET ; : 32-35, 2020.
Article in English | Scopus | ID: covidwho-1029043

ABSTRACT

The Covid-19 pandemic brought extraordinary disruption to the education landscape with the campuses closing everywhere almost overnight. Schools and colleges in India have a different pattern of education where one cannot physically attend classes but has to attend classes virtually, a new problem occurs. here we will analyze some issues like internet connectivity problems and basic understanding of technology and other such problems, to understand the problem more closely we make Google form and conduct survey and interact with 160 approx. The results of the study stated that most people faced internet problems and did not have the knowledge to use and solve problems related to technology. © 2020 IEEE.

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