Survival of Covid-19 Patients with Hypertension

Background: Coronavirus Disease-2019 (COVID-19) is an infectious disease caused by SARS-CoV-2 virus. Severity of this disease influenced by old age, sex, comorbidities, and other factors. Hypertension and type 2 diabetes mellitus are the most common comorbidities in COVID-19 patients that cause high morbidity and mortality. Objective(s): To analyze the survival of COVID-19 patients with hypertension comorbidity and compare it between diabetes mellitus and non-diabetes mellitus group. Method(s): This retrospective, descriptive study included COVID-19 patients with hypertension comorbidity at Internal Medicine ward Dr. Soetomo Hospital Surabaya from May 2020 to December 2021. Data on age, sex, hypertension, diabetes mellitus type 2, symptoms, vital signs, laboratory finding, length of stay, and outcome were taken from medical records and we carried out kaplan-meier method and log rank test by using SPSS. Result(s): This study obtained 698 sample of confirmed COVID-19 patients and after applying exclusion criteria there were 174 patients with hypertension comorbidity. Most patient were female (60.3%) and age 51-60 years (38.5%). The most common symptoms were shortness of breath (62.1%) and cough (50.6%). There were 50 hypertension and 79 non-hypertension patients died and Survival analysis showed a significant statistical difference between both groups (p=0.042). From 50 deceased hypertensive patients, there are 36 and 14 hypertensive patients with and without diabetes mellitus respectively but survival analysis showed a non-significant statistical difference between both groups (p=0.081) Conclusion(s): There is significant statistical difference in survival analysis in patients with hypertension. We should be aware about COVID-19 patients with hypertension.

Time-to-survival from COVID-19 disease and its associated factors in Osun State, Nigeria.

Introduction This study focused on estimating the probability of survival and the specific time to survival from COVID-19 among patients who had COVID-19 in Osun state, Nigeria. Also, we examined some factors associated with the time to survival among COVID-19 patients in Osun state, Nigeria. Methods The retrospective data of 2596 records of COVID-19 patients in Osun state were analysed in this study. The outcome variable was the "COVID-19 treatment outcome (survived=1, dead=0)". The time date used in the survival analysis was treatment duration (in days). The explanatory variables were demographic characteristics, type of health facility, vaccination status, symptoms, and mode of admission. The descriptive statistics was computed and presented. Kaplan Meier was used to estimate the median time to survival. Bivariate analysis and multivariate analysis were done using the Log-Rank test and Cox regression, respectively. P values were set at P<0.05. Results The mean age was observed to be 40 (SD=17.51) years, ranging from mostly, 2 months to 98 years old. More (56.1%) of the participants were males. Most (99.5%) of them were Nigerians. Only 1.4% were vaccinated. The survival rate from COVID-19 was 98.1% in Osun State. The median time for survival was 14 (IQR= 14- 16) days. COVID-19 reduces as the number of days for being on treatment increases. Unvaccinated (HR=0.93, 95%CI: 0.43-2.03) and those whose vaccination status was unknown (HR=0.52, 95%CI: 0.37-0.74) were less likely to survive COVID-19 diseases. Conclusion The Survival rate was high, the observed median time to survival was 14 days, and the probability of survival reduces as the number of days of being on treatment for COVID-19 increases. Also, gender, vaccination, type of care, and ethnicity were associated with survival time. Similarly, unvaccinated and inpatients were less likely to rapidly survive COVID-19. This study recommends that the COVID-19 vaccine should be encouraged among patients who have the COVID-19 virus. Also, home care may be further explored to assess its effectiveness in caring for COVID-19 patients. In the same vein, COVID-19 data capturing, and databases need strengthening in Nigeria.

Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients (Pts) with Relapsed/ Refractory Large B-Cell Lymphoma (R/R LBCL): 2-Year Follow-up of Zuma-1 Cohort 6

Background: The ZUMA-1 safety management Cohort 6 (N=40), which evaluated whether prophylactic corticosteroids and earlier corticosteroids and/or tocilizumab could improve safety outcomes, demonstrated an improved safety profile (no Grade >=3 cytokine release syndrome [CRS];15% Grade >=3 neurologic events [NEs]) vs pivotal Cohorts 1+2, without compromising response rate or durability (95% ORR, 80% CR rate, and 53% ongoing response rate with >=1 y of follow-up;Oluwole, et al. ASH 2021. 2832). Here, 2-y updated outcomes are reported. Method(s): Eligible pts with R/R LBCL underwent leukapheresis (followed by optional bridging therapy) and conditioning chemotherapy, then a single axi-cel infusion. Pts received corticosteroid prophylaxis (once-daily oral dexamethasone 10 mg on Days 0 [before axi-cel], 1, and 2) and earlier corticosteroids and/or tocilizumab for CRS and NE management vs Cohorts 1+2 (Oluwole, et al. Br J Haematol. 2021). The primary endpoints were incidence and severity of CRS and NEs. Secondary endpoints included ORR (investigator-assessed), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and chimeric antigen receptor (CAR) T-cell levels in blood. Result(s): As of December 16, 2021, the median follow-up time for the 40 treated pts was 26.9 mo. Since the 1-y analysis, no new CRS events were reported (no pts had Grade >=3 CRS to date). The incidence of Grade >=3 NEs increased from 15% to 18%between the 1-y and 2-y analyses. Two new NEs occurred in 2 pts: 1 pt had Grade 2 dementia (onset on Day 685 and ongoing at time of data cutoff;not related to axi-cel) and 1 had Grade 5 axi-cel-related leukoencephalopathy. Since the 1-y analysis, 6 new infections were reported (Grades 1, 2, and 5 COVID-19 [n=1 each], Grade 3 Pneumocystis jirovecii pneumonia [n=1], Grade 3 unknown infectious episode with inflammatory syndrome [n=1], and Grade 2 herpes zoster [n=1]). In total, 8 deaths occurred since the 1-y analysis (progressive disease [n=5], leukoencephalopathy [n=1], and COVID-19 [n=2]). The ORR was 95% (80% CR), which was unchanged from the 1-y analysis. Median DOR and PFS were since reached (25.9 mo [95% CI, 7.8-not estimable] and 26.8 mo [95% CI, 8.7-not estimable], respectively). Median OS was still not reached. Kaplan- Meier estimates of the 2-y DOR, PFS, and OS rates were 53%, 53%, and 62%, respectively. Of 18 pts (45%) in ongoing response at data cutoff, all achieved CR as the best response. By Month 24, 14/20 pts with evaluable samples (70%) had detectable CAR T cells (vs 23/36 pts [64%] in Cohorts 1+2). Conclusion(s): With 2 y of follow-up, the ZUMA-1 Cohort 6 toxicity management strategy continued to demonstrate an improved long-term safety profile of axi-cel in pts with R/R LBCL. Further, responses remained high, durable, and similar to those observed in Cohorts 1+2 (Locke, et al. Lancet Oncol. 2019).Copyright © 2023 American Society for Transplantation and Cellular Therapy

Comparison of the Effectiveness of Different Covid-19 Vaccines among Plwh

Background: Previous studies have demonstrated promising serologic responses in PLWH receiving a third dose of vaccine against SARS-CoV-2. However, real-world clinical effectiveness, especially during the pandemic caused by B.1.1.529 variant, remains less investigated. Method(s): PLWH seeking HIV care at our hospital from 2021/6 to 2022/6 were included and advised to receive the third dose of COVID-19 vaccine. Individuals were excluded from this study if they had been previously diagnosed with COVID-19. Different types of COVID-19 vaccines were available in the vaccination program, including BNT162b2, mRNA-1273 (either 50 or 100 mug), MVC-COV1901 and NVX-CoV2373 vaccines. PLWH were screening for the occurrence of COVID-19 through the reporting system of notifiable diseases of Taiwan CDC, and were tested for anti-nucleocapsid (anti-N) IgG every 1 to 3 months. Participants were followed for 180 days until the fourth dose of COVID-19 vaccination, occurrence of SARS-CoV-2 infection, seroconversion of anti-N IgG, death, or loss to follow-up, whichever occurred first. Result(s): 1,496 PLWH were included: 631 (42.2%) receiving 100 mug mRNA-1273 vaccine, 468 (31.3%) 50 mug mRNA-1273 vaccine, and 328 (21.9%) BNT162b2 vaccine, 65 (4.3%) MVC-COV1901 vaccine, and 4 (0.3%) NVX-CoV2373 vaccine for the third dose of SARS-CoV-2 vaccination. 297 (19.9%) PLWH were diagnosed with COVID-19 during the follow-up period, including 92 (14.6%) who received 100 mug mRNA-1273, 111 (23.7%) 50 mug mRNA-1273, 79 (24.1%) BNT162b2 and 15 (21.7%) either MVC-COV1901 or NVX-CoV2373;in addition, 98 PLWH had seroconversion of anti-N IgG during follow-up, including 23, 50, 19 and 6 PLWH who received 100 mug mRNA-1273, 50 mug mRNA-1273, BNT162b2, and either MVC-COV1901 or NVX-CoV2373, respectively. Similar rates of new infection with SARS-CoV-2 or seroconversion of anti-N IgG were demonstrated regardless the vaccine type of the third dose (log-rank test, p=0.46). Factors associated with a diagnosis of SARS-CoV-2 infection and seroconversion of anti-N IgG included an age >50 years (aOR, 0.67;95% CI, 0.49-0.91) and newly infected with hepatitis C virus (HCV) (aOR, 1.41;95% CI, 1.09-1.83). Conclusion(s): Our study demonstrated that clinical effectiveness of the third dose of different vaccines available to PLWH was similar in preventing SARSCoV- 2 infection or seroconversion of anti-N IgG Taiwan. PLWH aged less than 50 years and those with newly diagnosed HCV infection were at higher risk of acquiring COVID-19. Kaplan-Meier survival curve for acquiring COVID-19 or seroconversion of anti-N IgG in PLWH receiving different COVID-19 vaccination of the third dose (log-rank test, 4 groups, p = 0.46).

Anti-S-Rbd Titer and Risk of Clinical Progression in Patients with Covid-19 Pneumonia

Background: Antibodies (Ab) against the receptor-binding-domain of the spike protein (anti-S-RBD) elicited by SARS-CoV-2 infection or vaccination are deemed to be a correlate of protection. We aimed at assessing whether anti-S-RBD titer is associated with the outcome of subjects hospitalized with COVID-related pneumonia. Method(s): Adults hospitalized between Jul 2021 and Jul 2022 for COVID-19 with respiratory failure (SpO2 < 93% on room air) or radiological evidence of pneumonia were included if anti-S-RBD titer was measured within 72h of admission. Time between admission and death/need for intubation was described using Kaplan-Meier curves. Cox Regression analysis, stratified by vaccination status, was used to explore the association between anti-S-RBD titer and survival. Age, gender, days since symptom onset, immunosuppressive conditions and use of monoclonal Ab (mAb) were explored as possible confounders. Result(s): 534 patients were enrolled. Their mean age was 71 years, 63% were male and 61% vaccinated;42% had >=1 immunosuppressive condition among hematological or solid malignancy, HIV, diabetes, end-stage renal failure, liver cirrhosis, organ transplant or immunosuppressive treatment. Antibody titer was significantly higher among vaccinated than among unvaccinated patients (1166 vs 158 BAU/ml;p< 0.001). Among vaccinated subjects, lower titer of anti-S-RBD were measured among those with hematological malignancies (1282 vs 471 BAU/mL;p< 0.001) or who were receiving immunosuppressive therapy (1287 vs 537 BAU/ml;p< 0.001). Older age, shorter time between onset of symptoms and hospitalization and immunosuppressive conditions were associated with higher rates of death or intubation (Fig 1). Using Cox regression stratified for vaccination, a significant association between anti-S-RBD titer and risk of death/intubation was observed (per log2 BAU/ml increase, HR 0.93;95%CI 0.88-0.99;p=0.020), independently of age (per year increase, HR 1.03;95%CI 1.01-1.04), male gender (HR 1.00;95%CI 0.70-1.42) and presence of immunosuppressive conditions (HR 1.46;95%CI 1.01-2.10). Adjustment for mAb treatment did not change the results to a significant Extent. Conclusion(s): Low anti-S-RBD titer was associated with poor outcome among patients hospitalized for COVID19-related pneumonia, regardless of vaccination. In addition, older age and presence of immunosuppressive conditions remain important predictors of mortality. Kaplan-Meier Curves for intubation-free survival according to age, days from symptoms' onset, presence of immunosuppressive conditions and anti-S-RBD titer. (Figure Presented).

Hiv-Related Kaposi Sarcoma in East Africa: Contemporary Update on Stage and Survival

Background: Stage at time of diagnosis and survival after diagnosis are critical parameters regarding the control of any cancer in any geographical setting. Unlike in resource-rich settings where publicly funded cancer surveillance routinely monitors these parameters, these data are non-existent through routine means in resource-limited areas. This is particularly relevant for Kaposi sarcoma (KS) in East Africa, for which recent changes in HIV treatment and chemotherapy guidelines as well as the COVID-19 pandemic dictate an update regarding stage and survival. Method(s): From October 2021 to August 2022, we evaluated HIV-infected adults (age >= 18 years) with a new diagnosis of KS made in 4 different primary care facilities (or their associated inpatient units) in Kenya and Uganda using a process of rapid case ascertainment. KS diagnosis was confirmed by pathology. Participants were examined, at time of biopsy, to document the extent of lesions and subsequently monitored longitudinally for vital status. Result(s): Among 180 HIV-infected adults identified with new onset KS, 31% were women, and the median (IQR) age was 35 (29-42) years. At time of KS diagnosis, 95% of the participants were taking ART, and the median (IQR) CD4+ T cell count was 197 (46-354) cells/mm3;46%, 20%, 11% and 23% had plasma HIV RNA of < 40, 40-1000, 1001-10,000 and >10,000 copies/ml, respectively. The median number of anatomic sites with KS lesions per participant was 7 (4-11);26% of participants had oral KS lesions that interfered with either eating or speaking, 74% had KS-associated edema, and 86% had ACTG stage T1 (advanced KS). Over a median follow-up of 2.6 months (IQR: 0.75 to 5.5), 56 participants died, and only 3 lost to follow-up. Cumulative incidence of death (95% CI), via Kaplan-Meier estimation, at 2 months, 6 months and 8 months following KS diagnosis was 24% (18%-31%), 33% (26%-42%), and 38% (29- 49%), respectively (Figure). Conclusion(s): In a recently assembled community-based sample of adults with newly-diagnosed HIV-related KS in East Africa, the majority have advanced KS at the time of KS diagnosis, and survival is poor. The findings are stark in absolute terms for the Treat-All era and unchanged from parameters obtained in the 5 years prior, indicating no improvement in these aspects of the control of KS in the region. Along with primary prevention of KS (i.e., reducing its incidence), novel approaches are needed for earlier detection, more efficient linkage to oncologic care, and more potent therapy. Survival Among Adults with HIV-Related Kaposi Sarcoma in East Africa.

Molnupavir in Previously Uninfected Nonhospitalized Persons with Covid-19

Background: Clinical benefit of Molnupiravir (MPV) in COVID-19 infected subpopulations is unclear. Method(s): We used a matched cohort design emulating a target trial to analyze the VA COVID-19 Shared Resource database to determine the association of MPV with hospitalization or death within 30 days compared with untreated controls in previously uninfected non-hospitalized persons. Incidence of hospitalization/ death and absolute risk difference (ARD) with 95% confidence intervals were calculated for the treated and untreated groups. Result(s): Among 1,459 matched pairs, the incidence of hospitalization/death was not different among MPV treated vs. untreated controls (48 vs. 44 cases;ARD [95% CI] 0.27 [-0.94,1.49]). No benefit was observed among those >60 or <60 years old (ARD 0.27 [-1.25,1.79] vs. -0.29 [-1.22,1.80]), those with specific comorbidities, or by vaccination status. A significant benefit was observed in asymptomatic but not in symptomatic persons (ARD -2.80 [-4.74,-0.87] vs. 1.12 [-0.31,2.55]). Kaplan-Meier curves did not show a significant reduction in proportion of persons who were hospitalized or died among those treated with MPV compared with untreated controls (logrank P=0.7). Conclusion(s): MPV was not associated with a significant reduction in hospitalization or death within 30 days of COVID-19 diagnosis overall. A subgroup of patients presenting without symptoms experienced a benefit.

Hiv Viral Load and Time-to-Covid-19 Vaccination among People Who Inject Drugs

Background: Structural barriers to care among people who inject drugs (PWID) raise concerns about disproportionate access to essential services like COVID-19 vaccination. Given the heightened risk of serious complications resulting from SARS-CoV-2 infection, particularly among people living with HIV (PWH) with unsuppressed viral load, its critical to understand the role of HIV care among other factors associated with timely vaccination. We aimed to assess the role of HIV care on COVID-19 vaccination uptake among PWID. Method(s): We included 960 adult PWUD participating in the ALIVE (AIDS Linked to the Intravenous Experience) longitudinal study in Baltimore, Maryland, who were alive and in follow up as of April 2020. We ed COVID-19 vaccination data from electronic medical records linked to participants via the regional health information exchange. We conducted survival analysis to estimate time from broad vaccine eligibility (April 6, 2021) to completion of the COVID-19 vaccination primary series by HIV status (uninfected, virally suppressed PWH [HIV-RNA< 400 copies/mL], unsuppressed PWH [HIV-RNA >400 copies/mL]) and Cox Proportional Hazards regression to adjust for potential confounding by health status and substance use variables. Result(s): Our sample (N=960) was primarily black (77%) and male (65%) with 31% reporting recent injection drug use. Among 265 people living with HIV (PWH) in our sample (27%), 84% were virally suppressed. As of February 22, 2022, 539 (56%) completed the primary series, 131 (14%) received a single dose of mRNA vaccine and 290 (30%) remained unvaccinated. Compared to PWID without HIV, virally suppressed PWH were significantly more likely to complete the primary series (Adjusted Hazard Ratio [AHR]:1.23,95% Confidence Interval [95%CI]:1.07,1.50), while PWH with higher viral loads were less likely (AHR:0.72,95%CI:0.45,1.16). Sensitivity analyses with a subsample restricted to PWH confirmed significant differences in time to vaccination by viral load status (log-rank p-value: 0.016) and modeling with an origin of Dec. 12, 2020, yielded similar adjusted results. Conclusion(s): Among PWID with HIV, viral suppression is associated with quicker vaccination uptake, likely due to HIV care engagement. Alongside interventions targeting social determinants (e.g. low income, homelessness) and substance use behaviors (e.g. active injecting, stimulant use), targeted improvements along the HIV care continuum and other efforts to engage PWID may bolster vaccine uptake. Figure 1. Kaplan-Meier survival curve demonstrating time-to-vaccination (completion of COVID-19 primary series) in weeks by HIV status accounting for viral load (HIV-, HIV+ [VL <= 400 cells/muL], HIV+ [VL > 400 cells/muL]), including results for Log-rank tests for homogeneity among strata (p-value).

Impact of Absolute Lymphocyte Count (Alc) Frequency on Detection of Dimethyl Fumarate- Associated Lymphopenia

Introduction Lymphopenia is a known adverse event of dimethyl fumarate (DMF) with treatment dis-continuation recommended for patients with severe prolonged (>=6 months) lymphopenia. Because of the COVID-19 pandemic burden on healthcare systems, we retrospectively examined the impact of absolute lymphocyte count (ALC) monitoring frequency (every-3-months vs every-6-months) on lym-phopenia detection. Methods Samples from patients enrolled in phase 3 trials (DEFINE/CONFIRM) and the extension study (ENDORSE) were retrospectively analysed using 3-month or 6-month intervals. Lymphopenia was defined as ALC <0.91x109/L and severe lymphopenia as ALC <0.5x109/L. Times to the first lymphopenia event and first severe lymphopenia event were estimated using Kaplan-Meier methods. Results The analysis included 741 patients. There were 355 lymphopenia cases (76 severe) with 3-month monitoring, and 314 cases (70 severe) with 6-month monitoring. Over 120 months, incidence of first lympho-penia event was significantly different for 3-month vs 6-month monitoring (difference range: 2.64%-6.54%;P=0.0088). Incidence of first severe lymphopenia event was not significantly different for the two intervals (P=0.5866). Proportions of patients with severe prolonged lymphopenia with 3-month and 6-month moni-toring were similar (4.0% vs 4.2%). Conclusions The results of this study may be informative to clinicians managing pandemic-related health-care resource burdens.

Clinical Outcomes of Stage III Non-small Cell Lung Cancer Patients Treated With Radical Radiotherapy in a Institution in Brazil

Introduction: Lung cancer is the leading cause of cancer death. Most cases are diagnosed at advanced stages. Stage III cancers are treated in a curative manner, despite the low success rate. Our objective was to define the clinical and epidemiological profile of stage III non-small cell lung cancer (NSCLC) patients (pts) treated with radiotherapy (RT) and their response to therapy. Method(s): It is a retrospective and observational study of all non-surgical stage III NSCLC pts treated with RT with curative intent at a public cancer center in the south of Brazil between January/2016 and June/2022. Data collected: dates of biopsy, treatment initiation, image progression or relapse, death and last registration;ECOG-PS;sex;smoking status;histology;stage (TNM 7th Ed) and chemotherapy (CT) use. Survival analysis were performed using the Kaplan-Meier method and factors associated with the events were analyzed using Cox regression. Groups were compared with chi-square and Kruskal-Wallis tests. Result(s): Eighty-seven pts were identified;median age 63 years-old;46 (52%) male, 78 (90%) former or present smokers;51 (62%) ECOG-PS 0/1;49 (58%) squamous (sq) histology;48 (60%) stage IIIb;60 (68%) had abdomen, bone and brain scans;64 (73%) had concurrent CT, 11(13%) sequential and 12 (14%) exclusive RT;64 (74%) concluded RT;53 (60%) had disease progression or relapse and 47 (54%) died. It took a median of 77 days (d) from biopsy to treatment initiation, without difference between pre or during COVID-19 pandemic. The follow-up was of 305d, progression free survival 192d and overall survival 253d (median for all), using the treatment initiation as baseline date. Younger pts and ECOG-PS 0/1 pts were more commonly treated with concurrent CT (X2:8,87;p 0,0054 and X2:10,82;p 0,004 respectively). No factor influenced progression free survival on uni or multivariable analyses. Factors correlated with overall survival on univariable analysis were: ECOG-PS (hazard ratio (HR) 2,02;p 0,010);bone scan (HR 0,5;p 0,028);treatment conclusion (HR 3,53;p<0,0001). Multivariable analysis: ECOG-PS (HR 2,95;p 0,017), non-sq histology (HR 2,26;p 0,044);RT conclusion (HR 4,69;p<0,0001). Conclusion(s): Our study shows shorter overall and progression free survival than literature, with a large portion of patients being treated with ECOG-PS of 2 or greater and without adequate systemic staging. About one-quarter of patients did not conclude the treatment, and this was the most negative factor impacting survival next to ECOG-PS.Copyright © 2023

Severe COVID-19 infection predisposes patients to greater burden of hair loss

There is a growing body of evidence suggesting a link between COVID-19 infection and certain forms of hair loss, such as telogen effluvium. The present study aims to determine the prevalence of hair loss following COVID-19 infection and ascertain the role of COVID-19 severity as a risk factor for its development. A retrospective study was conducted using patient data from the Northwestern Medicine Enterprise Data Warehouse with institutional review board approval from Northwestern University. Patients aged >= 18 years with COVID-19 diagnoses between January 2020-June 2022 and >= 1 encounter with dermatology providers within 180 days post-infection were included in the study. History of COVID-19 and documented hair loss diagnoses were recorded along with demographic data. COVID-19 severity was classified based on whether the patient was given outpatient or inpatient/emergency care for COVID-19. Time-to-alopecia onset was calculated relative to the nearest preceding COVID-19 diagnosis. Pearson's chi-squared and Kaplan-Meier analysis were performed to evaluate differences in incidence and time-to-alopecia onset by severity of COVID-19 infection. Analyses were conducted using R 4.2.1. In total, 10,861 patients met the inclusion criteria for the study. Patients were more commonly female (N = 6,974, 64.2%) and White (N = 8,301, 76.4%) with a mean age of 48 years at COVID-19 diagnosis. Overall, 6.5% of COVID-19 patients treated in inpatient/emergency settings developed hair loss compared to 4.7% in outpatient settings (P = 0.009). Patients with outpatient care had a median time to alopecia diagnosis of 73 days, compared to 99 days for patients with inpatient/emergency care (P = 0.019). Our findings demonstrate hair loss following COVID-19 infection as a notable sequela of infection. Clinicians should closely monitor patients following hospitalization for COVID-19, as they may be predisposed to hair loss following infection due to psychological or physiological stress. Future studies should aim to validate our findings and explore this relationship on a larger scale.Copyright © 2023

Sars-Cov-2 Infection Does Not Worsen the Course of Inflammatory Bowel Disease in the Long Term

Background and aim: The long-term outcome of inflammatory bowel disease (IBD) patients after SARS-CoV-2 infection is under investigation. In a prospective, single-center study, we aimed to assess whether a recent SARS-CoV-2 infection increases the risk of IBD relapse within 12 months. Material(s) and Method(s): From March to April 2021, all IBD patients with recent (<2 months) SARS-CoV-2 infection (Cases) were enrolled. For each enrolled Case, 4 IBD Controls with no history of infection were considered. Clinical course of IBD was recorded for 12 months. Inclusion criteria: a) well-defined diagnosis of IBD;b) age >=18 and <=85 years;c) 12-months follow-up;d) consent. Exclusion criteria: a) incomplete data;b) SARS-CoV-2 infection after enrollment. Additional inclusion criteria: a) recent SARS-CoV-2 infection for Cases;b) no history of SARS-CoV-2 infection for Controls. Data were expressed as median [range]. Normal distribution of continuous variables was assessed through the Kolmogonov-Smirnov test. Statistical analysis included Student-t Test, Mann-Whitney u-test, 2 test, multivariate logistic regression model (OR [95% CI]), Kaplan- Meier curves, as appropriate. Result(s): During the study period, 143 IBD patients were enrolled. The analysis included 118 patients (22 met the exclusion criteria, 3 lost at follow-up): 29 (24.6%) Cases, 89 (75.4%) Controls. Demographic and clinical characteristics were comparable between groups. During the 12-months study, the frequency of IBD relapse was comparable between Cases and Controls (8 [27%] vs 19 [21%];p=0.65). At univariate analysis, SARS-CoV-2 infection was not a risk factor for IBD relapse within 12-months (1.5 [0.6-3.9];p=0.34). At multivariate analysis, IBD activity at baseline was the only risk factor for relapse (3.2 [1.1-9.1];p=0.03). Kaplan-Meier curves showed that survival from IBD relapse was comparable between Cases and Controls (p=0.33). Conclusion(s): In a prospective 12-months study, a recent SARSCoV- 2 infection did not increase the risk of clinical relapse of IBD in the long term.Copyright © 2023. Editrice Gastroenterologica Italiana S.r.l.

COVID-19 and the Psychosocial Impact of Breast Health Delays

INTRODUCTION: Reallocation of resources during the COVID-19 pandemic resulted in delays for breast health care. Data are sparse regarding the impact of these delays on psychosocial outcomes. METHOD(S): Women seeking breast health care across a multi-site breast program in a large metropolitan area were assessed for psychosocial outcomes including depression, stress, and anxiety as it related to delays in care. Psychosocial outcomes were evaluated utilizing validated instruments (PROMIS, PHQ-9). Outcomes were stratified by treatment group (healthy, breast cancer, survivor) and Kaplan-Meier curves created for breast cancer patients to evaluate the relationship of time to treatment stratified by dichotomous psychosocial outcomes. Demographic and clinical data was ed from the electronic medical record. RESULT(S): 85 women enrolled in the study including 30 (35%) breast cancer patients, 24 (28%) healthy women, and 31 (36%) breast cancer survivors. Overall, 58% reported a delay in breast health care including surgery, radiation, chemotherapy, medical oncology treatments, clinical appointments, breast imaging and/or biopsies, survivorship follow-up, support groups, and/or screening. Compared to women in the no delay group, a greater proportion of women reporting a delay had high anxiety (78% vs. 58%;p = 0.06), high perceived stress (45% vs. 28%;p = 0.17), high loneliness (67% vs. 32%;p = 0.003), moderate or higher depression (16% vs. 8.3%;p = 0.34), and no or low emotional support (58% vs. 28%;p = 0.008). Among breast cancer patients, the first treatment modality was surgery in 73% and the median time to treatment was 33 days. The median time to treatment was 40 days for breast cancer patients reporting a delay compared to 28 days for patients reporting no delay. Longer time to treatment was observed among breast cancer patients with high versus low anxiety, perceived stress, loneliness, and depression and for patients with low versus high emotional support. CONCLUSION(S): Women with and without breast cancer reporting a delay had worse measures for anxiety, depression, perceived stress, loneliness, and emotional support. Longer time to treatment was experienced by breast cancer patients with worse psychosocial measures. Risk stratification of women seeking breast health care during the COVID-19 pandemic is needed to identify and support those at risk for adverse psychosocial outcomes. (Table Presented).

A Study of Long-Term Outcome of Mycophenolate Dose Modulation in Renal Allograft Recipients With SARS-CoV2 Infection During COVID-19 Pandemic

Introduction: A significant reduction of acute rejection rates was observed after using Mycophenolate mofetil (MMF) in renal transplant recipients (RTR). However, side-effects like hematological and gastrointestinal intolerance often occur when MMF is used in routine doses.MMF dose reduction is required during its side-effects or co-existing infection in RTR.The outcome of MMF dose modulation in RTR is not well established. COVID-19 pandemic has given an opportunity to study the effect of MMF dose modulation on graft function as large number of RTR who had Covid19 received MMF dose reduction or discontinuation. This study's objective was to determine whether MMF dose reduction or discontinuation was associated with the effect on allograft function after renal transplantation. We included all RTR who had an infection with SARS-CoV2 and received MMF dose reduction or discontinuation Methods: We prospectively collected data of Renal transplant recipients developing covid 19 infection during the first and second covid waves. Management including decision on admission, immunosuppression modulation, antibiotics were done based on clinician's discretion subject to logistics and the prevailing guidelines by the ISOT. All patients were followed up for minimum 15 months for graft dysfunction, biopsy rate, biopsy proven acute rejection ( BPAR). The effect of immunosuppression modulation - MMF cessation (Group A) Vs MMF reduction/no manipulation (Group B) and its bearing on the incidence of rejection and was compared. Additional factors such as follow - up sub therapeutic CNI levels, development of DSA ( when done ), steroid increment were studied regression model. Kaplan - meier survival curves for 24 months drawn. Result(s): Among 251 renal transplant patients with SARS-CoV2 infection, 38 patients died during Index admission. 45 patients has not completed for 15 months.168 patients completed 15 month follow - up. Among them, anti-metabolite were reduced in 115 ( 68.5%), stopped in 42 (25%), not manipulated in 5 ( 3%) and 6 patients were not on anti-metabolites and hence excluded from present analysis. Of the 162 patients, MMF had been stopped for 2 weeks or until presumed clinical recovery in 42 patients ( Group A) and the rest in 120 patients ( Group B). Mean age was 41.18 ( +/- 12.8) and 75.6 % had mild COVID. Median duration of follow-up was 18 months ( 14q1-22q3 months). Total Readmission rate was 66 ( 40.7%) (Group A 21( 50%) Vs Group B 45 ( 37.5 %). Graft Biopsy was done in 16% of patients. 9.3 % patients had acute rejection ( 11.9% Vs 8.3%, p 0.05). Among those who had rejection, ABMR was seen in 2, ACR in 3, CABMR in 5 and combined rejection in 1. Conclusion(s): MMF dose modulation to tackle an infectious episode may be associated with graft dysfunction and rejection on follow-up and close follow up is needed in any patient in whom MMF dose in manipulated No conflict of interestCopyright © 2023

Impact of major medication discontinuation during the first wave of COVID-19 pandemic on the risk of early relapse in patients with inflammatory bowel disease: A French observational retrospective study

Background: The prevalence of nonadherence to major treatments and the subsequent adverse outcomes in IBD patients during the first wave of COVID-19 pandemic remain scarce Aim: To investigate the risk of early disease relapse in a cohort of IBD patients under immunosuppressants and/or biologics who decided themselves to discontinue their IBD-related major treatments without previous medical advice during the first wave of COVID-19 pandemic Methods: All consecutive patients with inactive IBD under immunosuppressants and/or biologics who acknowledged having withdrawn their major therapy for IBD without previous medical advice during the first wave of COVID-19 (from March 2020 to December 2020) were enrolled. The primary endpoint was the survival rate without disease relapse. Kaplan-Meier curves were plotted for time from inclusion to IBD relapse and a logistic regression model with uni- and multivariate analyses was performed to identify predictors of relapse after drug discontinuation Results: During the study period, among the 862 IBD patients followed as outpatients either treated with infliximab or vedolizumab (outpatient clinics n= 368) or treated with oral azathioprine, adalimumab golimumab or ustekinumab alone or in combination (n= 494), 54 patients (6.2 %) (42 CD, 12 UC, 28 F, median age 36 years) who had discontinued themselves their IBD-related major therapy without previous medical advice were included. The median duration of drug withdrawal was 7.0 weeks (range 2-24) and the median time to relapse was 9.0 weeks (range 4-20). The most treatments withdrawn were adalimumab (n=19), ustekinumab (n=19), azathioprine (n= 12), golimumab (n=1) and a lesser degree infliximab (n=7) eand vedolizumab (n=6). During the median follow-up period of 24 weeks (range 5-42), 22 out of 54 patients (40.7 %) who discontinued their IBD treatment experienced a relapse in whom 6 requiring administration of oral steroids, 4 hospitalization and 2 IBD-related surgery By univariate analysis, past IBD related surgery was identified as the only predictor of disease relapse after drug withdrawal (OR=3.3 CI 95 % [1.08-10.38] Conclusion(s): In IBD patients, major treatment discontinuation by the patients themselves without medical advices during the first wave of pandemic Covid-19 including the lockdown was associated with a substantial risk of disease relapse occurring in around 4 out of 10 patients and subsequent further risk of need for steroids, hospitalization and surgery. Strategies targeting the adherence to therapy and patient's informations about the real risks leading to drug discontinuation are of paramount interest, especially during health crisis to minimize such issues.

Prognostic value of initial KL-6 (Krebs von den Lungen 6) plasma level during COVID-19 pneumonia

Introduction: Krebs von den Lungen-6(KL-6) is useful in the diagnosis and severity assessment of diffuse interstitial lung disease. The objective of our study was to determine the prognostic value of the initial KL-6 plasma level in COVID-19 pneumonia Methods: All patients hospitalized between March 2020 and May 2020 for a suspected COVID-19 pneumonia in our Chest department of university hospital (Paris, France) were included. Initial referred as within 72 h of diagnostic suspicion, KL-6 plasma concentration in U/mL was measured by a ChemiLuminescent Enzyme Immunoassay (LUMIPULSE, Japan). Survival analyses were performed using a Cox regression and modeled by a Kaplan-Meier curve Results: 66 COVID-19 patients with initial KL-6 plasma measurement were analyzed, among whom 47 were men and average age was 64+/-14 yrs. Median KL-6 plasma concentration was 409+/-312 U/mL. KL-6 was significantly higher in men (p=0.003), elders (p=0.0001) and for higher Charlson's score (p=0.002). Higher KL-6 concentration was significantly associated with in-hospital mortality (HR: 8.66;95% CI:1.1-69.2), radiological extension of lesions on chest CT-scan (p=0.0040), higher WHO severity score (p=0.042), but not with admission in intensive care unit. In the 9 (14%) non surviving COVID-19 patients, KL-6 plasma concentration increased while it remained stable or decreased in survivors. At 3 months (n=48), DLCO was negatively correlated with the initial KL-6 value (r = -0.47, p=0.001) Conclusion(s): Initial KL-6 plasma concentration is associated with in-hospital mortality, unfavorable outcome, and persistent impairment of DLCO at 3 months. Initial KL-6 plasma determination appears as a prognostic biomarker in COVID-19 pneumonia.

High severity and mortality of non-COVID-19 critically ill patients during the COVID-19 pandemic

Background: The transmission and the fatality rates of coronavirus disease 2019 (COVID-19) are high enough to cause the strain of intensive care resources, and even influence the treatment and prognosis of non-COVID-19 patients. Therefore, the collateral damages to non-COVID-19 critically ill patients before and during the COVID-19 pandemic were evaluated. Method(s): Demographic data, severity, clinical course, and prognosis of non-COVID-19 patients admitted to the intensive care unit (ICU) via the emergency room (ER) before and during the COVID-19 pandemic were acquired from electronic medical records from three university-affiliated tertiary hospitals. Result(s): A total of 619 patients before and 542 patients during the pandemic were enrolled. During the COVID-19 pandemic, simplified acute physiology score (SAPS) 3 and the sequential organ failure assessment score (SOFA) on ER admission (SAPS3 72.7 +/- 20.3 versus 65.9 +/- 18.6, p <0.001, respectively;SOFA score 8.1 +/- 4.2, versus 7.2 +/-4.2, p <0.001, respectively) were significantly higher than those before the pandemic. The length of stay in the ER, ICU, and hospital was longer (p<0.05 in all). Finally, the hospital mortality rate was significantly higher during the pandemic than those before (39.7% versus 28.4%, p<0.001). The overall survival in the Kaplan-Meier curve analysis with log-rank test was significantly higher during the pandemic (p=0.04). Conclusion(s): These result of increased severity, hospital day and mortality in non-COVID-19 patients indicate the collateral damage to non-COVID-19 patients due to shortages in medical resources for them. Strategic management of medical resources is required to halt these consequences.

In bed hybrid tracheostomy procedure in COVID-19 patients. Technique and results

Background: COVID-19 pandemic, results in a great number of critically ill patients requiring long-lasting periods of invasive mechanical ventilatory support;tracheostomy is considered during their hospital stay, to free patients from ventilatory support and optimize the resources, we developed a safe in bed hybrid tracheostomy procedure to avoid the operating room and minimize SARS-CoV2 transmission due to aerosols exposure. Method(s): We developed this protocol using PDCA (Plan, Do, Check, Act) in order to perform a safe in bed hybrid tracheostomy: percutaneous tracheostomy + flexible bronchoscopy. We used the Ciaglia Blue Rhino technique and flexible bronchoscopy. We analyzed: Gender, age, body mass index, intubation days, ventilatory parameters, procedure time, apnea time, oxygen saturation, complications and patient clinical evolution. Statistical evaluation: Fisher test, U Mann-Whitney, T test, logistic regression and Kaplan-Meier curves. Result(s): From march 2020 to February 2021, 292 patients underwent hybrid tracheostomy;Tracheostomy was successfully completed in all patients: 211 men (72.2%);81 women (27.8%), age 58.5 years old, intubation days before tracheostomy 23 days (19 to 28 days), 133 patients (45.5%) deaths due to COVID19 complications. Procedure time 6 to 14 minutes (mean 9 minutes), apnea time 147 to 360 seconds (mean 240 seconds), O2 saturation 66%-96% (mean 87%), PaO2/fiO2 106-194 (mean 142), SOFA 4-6 (mean 5). No complications due to the trachesotomy. Conclusion(s): In bed hybrid tracheostomy procedure implementation with the PDCA cycles is safe, with good results, zero procedure complications and a good and rapid learning curve.

Therapeutic Effects of Corticosteroids for Critical and Severe COVID-19 Patients

The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has led to an unprecedented public health, economic, and social crisis worldwide. Since no therapeutic treatment is yet available to effectively clear the virus and terminate transmission, supportive therapy is the primary clinical approach for coronavirus disease (COVID-19). The role of corticosteroids as one of the main means of anti-inflammatory adjuvants in the treatment of COVID-19 is controversial. Here, we retrospectively evaluated the therapeutic effects of corticosteroids by comparing clinical data of patients treated with or without a corticosteroids therapy at different severity levels. Kaplan-Meier curves shows that therapy with methylprednisolone and cortico-steroids increases the risk of death in patients with critical COVID-19 pneumonia. For patients in the critical group, the risk of death was slightly higher in males receiving corticosteroids therapy, while hypertension and trauma history reduced the hazard ratio. © 2022, The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

Risk of in-Hospital Mortality Due to Covid19 in Patients with Bronchial Asthma: Application of 4c Mortality Scale

Role of asthma as a risk factor in severity and mortality in COVID-19 varies in literature. In 2020, 4CMortality score was published, which through 8 parameters in the initial evaluation (age, sex, comorbidity index Charlson, respiratory rate, peripheral oxygen saturation, renal function, Glasgow scale and C-reactive protein) stratified risk of in-hospital mortality from COVID-19 into low(0-3 points), intermediate(4-8), high(9-14) and very high(from 15). Our objective is to assess usefulness of 4CMortality in asthmatic patients admitted for COVID-19 and to verify the degree of correlation between the score and the mortality data and hospital stay. Observational retrospective study of asthmatic patients admitted for COVID-19 between March 2020 and March 2021. Statistical analysis is performed using Fisher's exact test(risk scale-death), ANOVA(risk scale-days hospitalization), and Kaplan Meier curve, considering statistically significant those results with a p<0.05. Sample of 99 patients, 18 in low risk group, 35 intermediate risk, 44 high risk and 2 very high risk. In terms of mortality, 7 deaths(high risk, 15.9%) and 2(very high risk, 100%), statistically significant (Fisher 17.07, p<0.0001). In terms of hospitalization days, median 7 days(low risk), 10(intermediate risk), 17 (high risk) and 5 (very high risk);statistically significant(F 6.37, p 0.001). In the survival analysis, median survival of 7 days(low-risk), 10(intermediate risk) and 19(high risk)(Log Rank 32.887, p<0.0001)(Fig 1). In conclusion, 4CMortality score is a good tool to establish the probability of poor evolution in asthmatic patients admitted for COVID-19 due to increased mortality and hospital stay.