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1.
Radiotherapy and Oncology ; 170:S1107-S1108, 2022.
Article in English | EMBASE | ID: covidwho-1967475

ABSTRACT

Purpose or Objective To illustrate a clinical application of Covid-Death Mean-Imputation (CoDMI) algorithm in survival analysis. CoDMI algorithm is a new statistical tool that allows to adjust, through mean imputation based on the Kaplan-Meier model, Covid-19 death events in oncologic clinical trials, providing a complete sample of observations to which any statistical method in survival analysis can be applied. Materials and Methods We analyzed a group of patients who received trimodal treatment – neoadjuvant chemoradiotherapy, followed by surgery and adjuvant chemotherapy – for primary locally advanced rectal cancer. Overall survival was calculated in months from the date of diagnosis to the first event, including date of the last follow-up or death. Because Covid-19 death events potentially bias survival estimation, to eliminate skewed data due to Covid-19 death events the observed lifetime of Covid-19 cases was replaced by its corresponding expected lifetime in absence of the Covid-19 event using CoDMI algorithm. In a traditional Kaplan-Meier approach, patient died of Covid-19 (DoC) can be: i) excluded to the cohort (but this would represent a loss of data), or ii) counted as censored (Cen) (but actually, due to its informative nature, Covid-19 death in a cancer patient cannot be censored as death from other causes), or iii) considered as died of disease (DoD) (but this provides an inappropriate exit cause). CoDMI algorithm offers an additional, more satisfactory option: iv) DoC events are mean-imputed as no-DoC cases at later follow-up times. With this approach, the observed lifetime of each DoC patient is considered as an “incomplete data” and is extended by an additional expected lifetime computed using the classical Kaplan-Meyer model. Results A total of 94 patient records were collected. At the time of the analysis, 16 patients died of disease (DoD), 1 patient died of Covid-19 (DoC) and 77 cases were censored (Cen). The DoC patient died due to Covid-19 52 months after diagnosis. CoDMI algorithm computed the expected future lifetime (beyond the DoC time of occurrence) provided by the Kaplan-Meier estimator applied to the no-DoC observations as well as to the DoC data itself. Given the DoC event at 52 months (red triangle in Figure 1), CoDMI algorithm (applied in its standard form) estimated that this patient would be died after 79.5 months of follow-up. The blue line in Figure 1 represents the newly estimated survival curve, where the additional DoD event is denoted by a circle. (Figure Presented) Conclusion CoDMI algorithm leads to the “unbiased” (appropriately adjusted) probability of overall survival in locally advanced rectal cancer patients with Covid-19 infection, compared with that provided by a naïve application of the Kaplan-Meier approach. This allows a proper interpretation/use of Covid-19 events in survival analysis. A user-friendly version of CoDMI is freely available at https://github.com/alef-innovation/codmi.

2.
Gynecologic Oncology ; 165:S4, 2022.
Article in English | EMBASE | ID: covidwho-1967455

ABSTRACT

Objectives: To investigate the utility of symptom review, serum CA125, and physical exam in the detection of ovarian cancer recurrence to determine the role of virtual surveillance care in the post- COVID-19 era. Methods: Patients diagnosed with ovarian cancer between 2013 and 2020 were identified and included if they completed standard of care treatment with surgical resection and platinum doublet chemotherapy, had no evidence of disease after completion of treatment, and had recurrence of disease detected by symptoms, CA125, physical exam, or imaging. Patients were excluded if they did not have pretreatment elevated serum CA125 (>35 U/ml) or a complete medical record. All recurrences were confirmed with imaging or biopsy. Modalities of recurrence detection were defined as the following: symptoms, physical exam, elevated CA125, or other. “Other” was denoted if imaging studies were obtained for reasons other than suspected recurrence and recurrence was incidentally identified. Descriptive statistics were used to summarize the cohort. Kaplan Meier analyses were used to estimate overall survival. Results: 109 patients met criteria at our institution. At initial diagnosis, the median age was 61 years (range 33-84) and most patients had advanced-stage disease, with 73 (67%) patients with Stage III disease and 26 (23.9%) with Stage IV disease. The median time to recurrence was 12 months (range 3-65) and median overall survival was 56 months (95% CI 46-79). In 46 (42.2%) patients, recurrence was suspected based on multiple modalities. At time of recurrence, elevated CA125 was present in 97 (89.0%) patients, symptoms in 41 (37.6%) patients, and abnormal physical exam findings in 27 (24.8%) patients. Of patients with abnormal physical exam, 26 (96.3%) also had elevated CA125 or symptoms present. Recurrence was suspected based on abnormal physical exam findings alone in 1 (0.9%) patient. Detection modalities other than abnormal physical exam (e.g., CA125, symptoms) were present in 102 (93.6%) patients. Recurrence was incidentally found with imaging obtained for reasons other than suspicion of recurrence in 6 (5.5%) patients.(Table Presented) Conclusions: Most ovarian cancer recurrences can be detected by rising CA125 or symptoms. Physical exam may have limited value in the detection of recurrence. Review of CA125 and symptoms can be conducted virtually. The inclusion of virtual visits for ovarian cancer surveillance should be considered for patients with pretreatment elevated CA125.

3.
12th International Conference on Biomedical Engineering and Technology, ICBET 2022 ; : 191-196, 2022.
Article in English | Scopus | ID: covidwho-1962432

ABSTRACT

This study presents the recovery patterns of COVID-19 patients in the Philippines using survival analysis in the multiple decrement setting. A total of 152,203 patients during the period January to December 2021 were included in the study. Data processing using Python and exploratory data analysis were employed. Probabilities were obtained using basic actuarial principles on two decrements: recovery and death. Kaplan-Meier estimation was then applied to obtain estimates of the survival function. The average length of treatment before recovery and death was also obtained. Results showed that older patients have higher risk of dying from COVID-19 compared to younger patients. While infection is higher among female population, the risk of death is higher among male patients. Based on the survival rates, the probabilities of recovery are highest during the 3rd week from onset of symptoms and the average length of treatment before recovery is determined to be 6 days. © 2022 ACM.

4.
Supportive Care in Cancer ; 30:S21, 2022.
Article in English | EMBASE | ID: covidwho-1935787

ABSTRACT

Introduction COVID-19 infection is associated with a higher incidence of medical complications including AKI. It is not well known if racial differences are associated with worse outcomes. Methods All patient data from March 2020 through February 2021 were aggregated and analyzed as part of the D3CODE protocol at MD Anderson. Cohort: (1) positive COVID-19 test (2) baseline eGFR >60 ml/min/ 1.73m2 within 30 days prior to COVID infection. AKI defined by increased creatinine ≥0.3 within 30 days after infection. Kaplan-Meier analysis was used for survival estimates. Multivariable Cox Proportional Hazard model regression analysis was used for hazard ratios. Results 635 patients with Covid-19 infection were identified. 124 (19.5%) developed AKI. AKI patients were more likely to have pneumonia (63.7% vs 37%, p<0.001), cardiac arrhythmias (39.5% vs 20.7%, p<0.001) myocardial infarction (15.3% vs 8.8%, p=0.046), require dialysis (2.4% vs 0.2%, p=0.025), mechanical ventilation (16.1% vs 1.8%, p<0.001), ICU admission (43.5% vs 11.5%, p<0.001) within 30 days, and had a higher mortality at 90 days of admission (20.2% vs 3.7%, p<0.001). Hispanic or Latino ethnicity (HR 56.6 CI 2.12-1510.57 p=0.016) vs White (HR 0.35 CI 0.02-6.02 p=0.47) was an independent risk factor associated with worse outcomes Conclusions Being Hispanic is associated with worse clinical outcomes in cancer patients with COVID-19 infection and AKI. Further studies are needed to address these disparities.

5.
Journal of Hypertension ; 40:e168, 2022.
Article in English | EMBASE | ID: covidwho-1937704

ABSTRACT

Objective: SARS-CoV-2 infection could be complicated by serious autonomic imbalance caused directly by the virus or through secondary release of inflammatory cytokines. Some studies suggested that elevated resting heart rate (HR) and resting tachycardia, being markers of an increased adrenergic cardiac drive, are associated with poor prognosis in COVID-19 syndrome. Design and method: We performed a retrospective analysis in an inpatient cohort of 389 subjects diagnosed with SARS-CoV-2 infection to investigate the prognostic relevance of HR in predicting the maximum care intensity needed during hospitalization according to the following four severity outcome classes: I) no need for oxygen support/ need for low flow oxygen therapy;II) need for high flow oxygen therapy/continuous positive airway pressure;III) transfer to the Intensive Care Unit;IV) death. HR assessments were recorded on admission and during the first 3 and 7 days of hospitalization. Results: For each class increase in maximum care intensity we observed a corresponding significant increase in HR, considering both data collected on admission (average HR value: 90.1 ± 17 beats/minute, p-value trend = 0.0397), and during the first 3 days (p-value trend < 0.0006) or 7 days (p-value trend < 0.0001) of hospitalization. The significant trend was maintained after adjustment for age, sex, comorbidities and fever and in the subpopulation of patients (n = 118) not receiving drugs potentially active on HR both before and during hospitalization. Kaplan- Meier curves for survival based on HR displayed a significant decreased survival in patients with higher HR. Conclusions: The assessment of HR during hospitalization provides information on the clinical outcome of patients affected by SARS-CoV-2 infection independently of other confounders. HR as an in-hospital prognostic marker can be obtained both through a first assessment at the admission or mean values over the course of hospitalization with an increase of its accuracy by a 7-days longitudinal evaluation. Further studies might elucidate the association between SARS-CoV-2 infection with multiple autonomic abnormalities.

6.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927907

ABSTRACT

Rationale Researchers are racing towards the goal of effective biomarker which could assess the prognosis in patients with COVID-19. Chitotriosidase (CHIT) is an integral part of immune response. This enzyme is expressed by activated macrophages. The role of CHIT in COVID-19 patients was presumed as a predictor of mortality, but this data is unclear. This study aimed to determine the potential influence of CHIT on survival in patients with COVID-19. Methods The single-center cohort prospective observational analyzed hospitalized patients with COVID-19 from November 2020 to February 2021 (Clinical Trial Registry: NCT04752085). Inclusion criterion was hospitalization with COVID-19 according to the modern guidelines. Exclusion criteria were history of hospitalization with COVID-19 infection, discharge from the hospital before the end of the treatment course, transfer to another hospital. Serum chitotriosidase (CHIT) level was defined on admission. The outcomes were assessed via phone calls on 90 and 180 days. The Kaplan-Meier estimator was used in our study for assessment of survival function. Results Baseline characteristics of 357 patients with COVID-19 were following: age (65.2 ± 14.1 years), gender (males: 48.5%), length of illness at the time of inclusion in the study (8.1 ± 4.4 days), CT stages of lung damage: 0-2 (84.3 %), 3-4 (15.7 %). 30 patients died during admission. 2 patients died in the first 30 days after discharge from hospital. 68 patients were lost to follow up within 180 days. The level of serum CHIT between survivors was significantly lower than in non-survivors (90.5 [40.2;178.0] nmol/h/mL vs 180.0 [77.2;393.2] nmol/h/mL, p=0.001). Survival of patients with baseline CHIT level greater than 171 ng/h/mL was much worse especially in the first 30 days of follow-up (Table 1). Table 1. Kaplan-Meier test showing survival in COVID-19 patients with chitotriosidase level above the cut-off of 171 nmol/ml/h. Conclusions Our study proves that CHIT level more than 171 nmol/h/mL on admission can assess a short-term prognosis. Assessment of CHIT is preferable as a potential biomarker of short-term survival. Further research needs to be conducted in larger cohorts of patients.

7.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927860

ABSTRACT

RATIONALE: Around 4.6 million people in the United Kingdom (UK) have asthma, with an estimated 5.7% treated for severe asthma. Benralizumab is indicated for the treatment of severe eosinophilic asthma (SEA) in adults inadequately controlled despite appropriate maintenance therapy. The Connect 360 Patient Support Programme (PSP) for patients on benralizumab includes options for home-based drug administration, education and adherence support by trained nurses - of particular relevance during the COVID-19 pandemic. Limited evidence exists on the benefit of PSPs for asthma patients or those administering biological therapies at home. This study aims to describe patient characteristics, key outcomes and experience with the PSP using UK data from Connect 360. METHODS: A non-interventional, retrospective cohort study of patients, enrolled in the PSP (Oct-2019 onwards) and consenting to the use of personal data for research purposes (“study cohort”). Patients opting for additional support services with at least one nurse interaction within described study timeframes formed the clinical cohort. Patients were observed up to 48 weeks post-PSP enrolment (interim data taken on 31-Mar-2021;data collection ongoing) with study endpoints assessed at baseline (0-4 weeks), 24 (±4) weeks and 48 (±8) weeks post-PSP enrolment. Characteristics at enrolment are described for the study cohort. Patient-reported clinical outcomes (hospitalisations, maintenance oral corticosteroid [mOCS] use, Asthma Control Questionnaire [ACQ-6] scores) and service satisfaction (1-5 point scale, 5 being most satisfied) were analysed where available from routine PSP nurse calls/visits. Analysis was descriptive;Kaplan-Meier estimators were used to estimate PSP discontinuation rates. RESULTS: The study cohort was 611 patients (mean enrolment age: 54.1 years, 63.2% female [N=323]). Most (98.9%) were benralizumab users on maintenance dosing (8-weekly) at enrolment. The clinical cohort consisted of 149 (baseline), 175 (24 weeks) and 195 (48 weeks) patients. PSP discontinuation rates were 4.4% and 11.6% at 24 and 48 weeks. Proportion of patients reporting mOCS use was 49.7%, 44.0% and 32.8% at each timepoint and hospitalizations were 10.9% and 4.1% at 24 and 48 weeks. Mean ACQ-6 scores decreased over time. Mean (SD) satisfaction scores were 4.6 (0.7) and 4.8 (0.5) at 24 and 48 weeks, respectively. (Table 1). CONCLUSIONS: Overall patients' experience with the PSP was positive, evidenced by high satisfaction with and persistence to the PSP. Where data were available, proportion of patients reporting mOCS and hospitalizations at 48 weeks were numerically lower than previous timepoints and mean ACQ-6 scores improved, suggesting a positive impact of benralizumab treatment within the PSP.

8.
Basic and Clinical Pharmacology and Toxicology ; 130(SUPPL 2):19-20, 2022.
Article in English | EMBASE | ID: covidwho-1916053

ABSTRACT

Objective: Tocilizumab (T) and corticosteroids (C) were two of the drugs used to stop the hyperinflammatory state of critically ill patients at the beginning of the COVID-19 pandemic. The objective of this study is to make a comparison of the efficacy and safety between the two drugs and the combination of both. Material and/or methods: All patients with SARSCOV2 infection from our centre during the first wave of the pandemic who had been treated with T, C or a combination of both (CT) were selected from the IDI-REM- 2020-01 COVID-19 Registry (NCT04347278). A descriptive study was carried out with an assessment of survival, mean stay (MS) in Intensive care unit (ICU) and risk of co-infection for these treatments. Results: Of 86 patients (54 men/32 women), 29 received T (33.7%), 37 C (43.1%) and 20 TC (23.2%). Median age was 66 ± 14 years, increasing in C (71 ± 15) and decreasing in T (60 ± 12) and TC (67 ± 13). The 48.9% of the patients with T and TC were admitted to the ICU compared to 8.1% of the patients with C, data related to age criteria. The median MS in the ICU decreased in the CT group at 7(±4) days compared to the T group (15 ± 3). There was no difference between the three therapies for general hospitalization MS (21 ± 5.5 to 23 ± 5.3). The 55.2% of the patients treated with T and 30% treated with CT had co-infection compared to 21.6% of the patients treated with C. Finally, a Kaplan-Meier analysis was performed, verifying a trend to have a longer survival in patients treated with T and CT, compared to C, although without statistical significance (χ2: 0.161) by sample size. Conclusions: CT appears to be more effective than T and C in patients with severe COVID-19 disease. These results support the limited literature;however, more powered studies will be required to evaluate these results.

9.
Nephrology Dialysis Transplantation ; 37(SUPPL 3):i599-i600, 2022.
Article in English | EMBASE | ID: covidwho-1915747

ABSTRACT

BACKGROUND AND AIMS: The clinical follow-up of CKD patients by nephrologists before RRT initiation (RRTi) is recommended by the practice guidelines starting with stage 3b CKD [1]. Despite this, the real-life implementation in clinical practice suggests otherwise, based on the paucity of papers reporting on the matter [2, 3]. In Romania, where the representation of the nephrology outpatient care is scarce, partly because of the low number of specialists, the establishment of outpatient clinics attached to dialysis units could be a solution. The purpose of this analysis is to evaluate, for the first time, if nephrological monitoring through the Diaverum outpatient clinics has benefits for CKD patients. METHOD: A total of 344 patients from 9 Diaverum clinics have been evaluated (335 haemodialysis, 9 peritoneal dialysis), our present analysis retaining only those starting haemodialysis, of which 118 started RRT in the 3 years between 1 January 2015 and 31 December 2017 and were monitored through the nephrology outpatient and 217 were patients there were not referred to a nephrology unit until RRTi, in the 2 years between 1 July 2016 and 1 July 2018. Clinical and laboratory data were gathered at RRTi and the follow up was investigated over a period of 3 years for both groups, starting from the end of the inclusion period, using anonymized records from the electronic database of Diaverum. Collected data were compared using the Pearson test for nominal variables and the Student's t-test and Wilcoxon Mann-Whitney U-tests for continuous variables. Survival analysis was employed using the Kaplan-Meier estimate and Cox regression models. RESULTS: The patient groups had similar general characteristics: most were men, >40% being elder (>65 yo), ∼30% had DM and both groups were comprised of subjects with multiple comorbidities (a mean Charlson score of 6). For patients that were not nephrologically referred, RRT was started in 100% of the cases using a CVC, while AVFs were employed in a majority of those followed through the outpatient clinics. In both groups, the mean eGFR was similarly <10 mL/min/1/73 m2, but >7 mL/min/1.73 m2, reflecting an alignment to clinical practice guidelines [1]. The median level of haemoglobin and the percentage of those with an optimal level of haemoglobin were higher in the group of monitored patients (9.9 versus 8.4 g/dL, respectively, 42% versus 15%).The nutrition status faired better in monitored patients: BMI (26 versus 23.3 kg/m2) and serum albumin (3.8 versus 3.5 g/dL). Serum calcium levels were higher (8.8 versus 8.3 mg/dL) and serum iPTH levels were lower (264 versus 331 pg/mL) in monitored patients, suggesting a better control of CKD-MBD, but serum phosphate was higher (5.7 versus 4.64 mg/dL), possibly reflecting a better nutrition status. The number of hospital admissions, COVID-19 cases and deaths are hard to compare, given the different observation periods that covered different periods and waves of the COVID-19 pandemic. However, hospital admissions and COVID-19 cases seemed more frequent in those that were not monitored. The 4 year survival rate was significantly higher (59% versus 51%) in the Kaplan- Meier analysis for those monitored through the outpatient. In the multivariate analysis, statistically significant associations with mortality were observed for diabetic and unmonitored patients. A major bias in our analysis is the difference between the periods of follow-up, which featured different periods of the COVID-19 pandemic. CONCLUSION: This is the first observational analysis on a nephrological patient population from Romania, which was followed through outpatient units until the initiation of RRT. Patient monitoring before RRTi potentially allows: for a better control of the main complications of CKD (anaemia, CKD-MBD), a better preparation for RRTi (a more frequent use of an AVF) and possibly for an improvement in morbidity and mortality, as suggested by previous studies on the benefits of nephrological monitoring before RRTi [4, 5].

10.
Nephrology Dialysis Transplantation ; 37(SUPPL 3):i63, 2022.
Article in English | EMBASE | ID: covidwho-1915661

ABSTRACT

BACKGROUND AND AIMS: Renal failure severe enough to require dialysis is an independent predictor of poor survival outcomes in multiple myeloma (MM). Significant early mortality (EM) was also determined in patients with MM infected by COVID-19. To evaluate the EM rate and investigate the risk factors associated with EM in MM patients. METHOD: Medical records of patients from the hematology unit of UHC 'Mother Teresa' with MM between January 2020 and March 2021 were reviewed. Out of 183 patients, 33.3% have in presentation myeloma-related kidney disease (MRKD). The statistical methods consisted of Kaplan-Meier survival curves, the log-rank test, logistic regression analysis and the ROC curve for mortality analysis. RESULTS: We evaluated 61 patients with MRKD, with 67.2% men;the mean age was 66.2+ (8.7) years. The incidence of MRKD was 41%, and 19.7% of MRKD patients underwent haemodialysis treatment. The 1-year mortality rate was found 29.5% (P < .01), where the EM rate was 13.1%, from which 62.5% needed dialysis. During follow-up, 10% of patients with MRKD had confirmed positive SARS-COV2 tests, associated with a high mortality rate of around 67%. AUC for creatinine value was 0.828, while it had a specificity of 88.37% and a sensitivity of 77.78% at a cut-off value >4 mg/dL (Figure 1). Multivariate logistic regression found creatinine >4 mg/dL, haemodialysis and COVID-19 remained independent predictors of high mortality in MRKD patients after being adjusted for cofounders (Figure 2). CONCLUSION: High incidence of MRKD indicates under recognition of MM. Mortality from COVID-19 infection in MRKD was relatively high, 22.2%. Renal failure is the second most common cause, after infection, of EM in MM patients. It is potentially reversible, so it is of high-interest early diagnosis and management of MRKD for more prolonged survival. Prophylactic measures in patients with preexisting-kidney failure may further reduce this risk.

11.
Italian Journal of Medicine ; 16(SUPPL 1):1, 2022.
Article in English | EMBASE | ID: covidwho-1913160

ABSTRACT

Background and Aim: The aim of this study is to evaluate gender differences in patients hospitalized for COVID-19 in terms of symptoms, laboratory data and disease outcomes, and to identify variables capable of increasing the risk of critical illness and lethality. Methods: Prospective observational study in the COVID wards of the ASST Fatebenefratelli-Sacco (MI), during the first wave of the pandemic. All COVID patients were included. A descriptive analysis was carried out to assess the relationship between several variables and gender, and a multivariate analysis to establish the association of the variables analyzed with disease severity and in-hospital mortality. The probability of survival at 30 days was evaluated by Kaplan-Meier curves. Results: 520 patients, 67% male and 33% female, were recruited. Of males, 30.1% presented with critical conditions at hospitalization, 18.7% in females. Mortality was 24.6% among males and 15.8% in females. Criticality at onset was associated with: high CRP, elevated LDH, increase of days from onset of symptoms. Mortality during hospitalization was associated with: age, obesity, critical conditions at admission, some laboratory analytes (decreased haemoglobin, elevated D-dimer, elevated LDH, reduced eGFR, elevated CK). The 30-day survival probability was 88% for women and 77% for men. Conclusions: Females are more protected against SARS-CoV-2 infection, have a better clinical and laboratory profile and subject to less lethality. Males are more hospitalized and more at risk of developing severe and lethal forms of the disease.

12.
Open Access Macedonian Journal of Medical Sciences ; 10:1056-1061, 2022.
Article in English | EMBASE | ID: covidwho-1896942

ABSTRACT

BACKGROUND: Early identification of clinical outcomes is necessary for risk classification in COVID-19 patients. This study help in evaluating the progression of the disease and the patient’s therapy. AIM: This study aims to determine serum ferritin levels for the prediction of mortality among COVID-19 patients in an Indonesia’s National Referral Hospital. METHODS: A retrospective cohort study was conducted on 142 confirmed positive COVID-19 patients between March 2020 until March 2021 at Dr. M. Djamil General Hospital as a National Referral Hospital in Indonesia. Data obtained from medical record documents and examination of ferritin levels was carried out at the beginning of treatment. The Chi-square test and survival analysis with the log-rank test and Kaplan–Meier methods were used to analyze the data. The SPSS version 15 was used to analyze the data. RESULTS: The serum ferritin cutoff point for COVID-19 patients that can be used to predict poor outcomes was >651.02 ng/mL with sensitivity 79.3%, specificity 80.5%, and accuracy 85.0%. Age, comorbid diabetes mellitus, number of comorbidities, symptoms of trouble breathing, oxygen saturation, severity, and mortality outcome were all associated to ferritin levels >651.02 ng/mL. The Kaplan–Meier curve showed that ferritin levels >651.02 ng/mL were associated for risk of poor outcome COVID-19 patients (HR = 8.84, [95% CI 3.59–21.73]). CONCLUSION: The ferritin cutoff point for predicting poor prognosis in COVID-19 patients was 651.02 ng/mL. However, ferritin serum levels cannot be used as a single predictor in determining the poor outcome of COVID-19.

13.
Topics in Antiviral Medicine ; 30(1 SUPPL):357-358, 2022.
Article in English | EMBASE | ID: covidwho-1880895

ABSTRACT

Background: After COVID-19 shelter-in-place (SIP) orders on 3/16/2020, viral suppression (VS) rates initially decreased within a safety-net HIV clinic in San Francisco, with greater decreases among homeless people living with HIV (PLWH). We sought to understand if (1) proactive outreach to provide social services, (2) scaling up of in-person visits for most patients and drop-in visits at the clinic, and (3) expansion of housing programs could reverse this decline. Methods: We assessed VS 24 months before and 13 months after SIP using mixed-effects logistic regression and propensity score methods, followed by interrupted time series (ITS) analysis to examine changes in the rate of viral suppression per month. Loss to follow-up was assessed via active clinic outreach and tracing using Kaplan-Meier methods. Results: The cohort contained 1816 patients with a median age of 51;12% female, 14% unstably housed, and 15% with CD4+-cell counts <200 cells/mm3. The adjusted odds of VS increased 1.34-fold following the intervention (95% CI: 1.21-1.46), with similar results using inverse probability weighting (adjusted odds ratio (AOR) 1.31;95% CI: 1.17-1.46). Results from the ITS analysis show that the odds of VS continuously increased by 1.05-fold per month over the post-intervention period (95% CI: 1.01-1.08, Figure). Proactive phone outreach successfully reached 90.0% of the clinic to offer services. The one-year cumulative loss to follow-up rate was 3.2% (95% CI: 2.5-3.9%). The proportion of total attended visits that were telephone visits decreased from a maximum of 64.9% to a minimum of 10.1% at the end of the analysis period. The rate of viral load monitoring decreased by 15% after the institution of SIP (95% CI: 0.83-0.88). Among homeless PLWH, the AOR for VS was 1.70 (95% CI: 1.24-2.34) and there was a 5.9% increase in VS per month using ITS methods (95% CI: 1.0-12.3%). Conclusion: After an initial destabilization in VS in a large safety-net clinic following SIP orders, the VS rate increased following scale-up of in-person visits, clinic outreach to patients, intensification of social services during this time, and access to COVID-related housing programs. The loss to follow-up rate was similar or lower compared to prior years. Maintaining in-person care for underserved patients, with flexible telemedicine options, along with provision of social services and permanent expansion of housing assistance programs, will be needed to support VS among underserved populations during the COVID-19 pandemic.

14.
Topics in Antiviral Medicine ; 30(1 SUPPL):377, 2022.
Article in English | EMBASE | ID: covidwho-1880670

ABSTRACT

Background: Since 2004, USAID Nigeria has supported the provision of antiretroviral therapy (ART) to 575,000 people living with HIV (PLHIV) in Nigeria through PEPFAR. Six decentralized drug distribution (DDD) ART delivery models were implemented in Akwa Ibom and Cross River states to improve continuous access to treatment for PLHIV, with the goal of achieving long-term retention in care and viral suppression. Methods: A retrospective analysis of 85,245 treatment patients who began ART between October 2001 and December 2020 was conducted. Patient data was extracted from electronic record systems and anonymized. All patients on first-line ART were included. Retention was defined as being alive and remaining on ART after initiation for at least 12 months after starting ART. While eligibility to all DDD models was restricted to stable patients, Community Pharmacy ART Refills Program (CPARP), Community ART Refill Clubs (CARCs), Family-Centered ART Refills Groups (F-CARGs), Fast-track clinic, and Adolescents Refill Clubs (ARCs) were all expanded to include stable and unstable patients after the onset of COVID-19. The Self-forming Community ART Refill Groups (S-CARG) model remained open only to stable patients. The Kaplan-Meier method was used to estimate retention probabilities, and Cox Proportional Hazards model was used to examine factors associated with retention. Results: Of the total sample, 63,175 (74%) remained on treatment and 13,800 (16%) experienced treatment interruption/LTFU. Median age at ART initiation was 39 years (IQR:32-47) and 69% of the cohort was female. Overall retention probability was 95%, 72% and 62% at 12, 24 and 36 months, respectively. The median retention time in the CPARP model was 73 months (95%CI: 71-74) compared to 49, 47, 18, 16, and 14 months in the CARC, Fast-track, ARC, F-CARG, and S-CARG models, respectively, log-rank test (p<.001). CARC DDD model [Hazard Ratio (HR):0.70 (0.66-0.73), ref: ARC], CPARP [HR:0.56 (0.53-0.60), ref: ARC], Fast-track [HR:0.70 (0.79-0.83), ref: ARC], female sex [HR:0.96 (0.94-0.97), ref: male], and 15+ years Age [HR:0.80 (0.77-0.84), ref: <15 years] were associated with long-term retention;while unemployed Occupation [HR:1.10 (1.08-1.13), ref: employed] and senior secondary Education [HR:1.20 (1.14-1.26), ref: junior secondary] were associated with short-term retention. Conclusion: Decentralized Drug Delivery models were associated with improved rates of continuity of ART treatment in a large real-world cohort in Nigeria.

15.
Topics in Antiviral Medicine ; 30(1 SUPPL):177-178, 2022.
Article in English | EMBASE | ID: covidwho-1880620

ABSTRACT

Background: Treatment guidelines recommend the use of tocilizumab in patients with a current CRP >7.5 mg/dl. Recent data showed that survival benefit might be greater in those with higher CRP levels. We aimed to estimate the causal effect of intensification with tocilizumab on mortality overall and after stratification for PaO2/FiO2 ratio, CRP levels. Methods: Observational cohort study of patients with severe COVID-19 pneumonia. Primary endpoint was day-28 mortality. Survival analysis was conducted to estimate the conditional and average causal effect of tocilizumab intensification vs. glucocorticoids alone using Kaplan-Meier curves and Cox regression models with a time-varying variable for the intervention. Analysis was controlled for age, ethnicity, duration of symptoms, at hospital admission (baseline, BL) PaO2/FiO2 ratio, CRP (BL and current), Charlson comorbidity index and post-BL use of remdesivir and invasive mechanical ventilation. The hypothesis of the existence of effect measure modification by CRP and PaO2/FiO2 ratio was tested by including an interaction term in the model. Results: 992 patients median age 69 years, 72.9% males, 597 (60.2%) treated with monotherapy and 395 (31.8%), adding tocilizumab upon respiratory deterioration were included. At BL, median CRP was 6.0 mg/dl (IQR 3.0-15.0) and median PaO2/FiO2 ratio was 261 mmHg (200-303). The two groups differed for median values of: CRP (6 vs 7 mg/dL;p<.001)), IL-6, (27.6 vs 175.0 mg/L;p<.001) LDH (525 vs 622 U/L;p<.001), lymphocytes (939 vs 835/mm3;p<.001) and PaO2/FiO2 ratio (276 vs 235 mmHg;p<.001) at BL. In the unadjusted analysis there was no statistically significant difference in mortality between the two groups, but there was strong evidence for an effect of the intensification after controlling for key BL and post-BL confounders, consistent with the estimate in trials (adjusted hazard ratio (aHR)=0.59, 95% CI:0.38-0.90). Although the study was not powered to detect interactions (p>0.57) there was a signal for intensification to have a larger effect in subsets, especially participants with high levels of CRP at intensification (Figure). Conclusion: Our data suggest that intensification with tocilizumab confers reduced survival benefit in those intensifying with a CRP of 0-7.5 mg/dl. It also provides substantial benefit even in patients who are intensified with a CRP>15 mg/dl. Large randomised studies are needed to establish an exact cut-off for clinical use.

16.
Topics in Antiviral Medicine ; 30(1 SUPPL):114, 2022.
Article in English | EMBASE | ID: covidwho-1880598

ABSTRACT

Background: COVID-19 is characterized by a dysregulated inflammatory response associated with disease severity, poor prognosis and death. The aim of this study was to describe the real-life use of high-dose anakinra (ANK, a recombinant IL-1 receptor antagonist) among patients with COVID-19 who received remdesivir (REM). Methods: Cohort study including 277 patients with COVID-19 hospitalized at IRCCS San Raffaele Hospital between September 1st,2020 and February 28th, 2021;58 patients were treated with REM+ANK and 219 patients with REM only. ANK was administered intravenously at a dose of 5mg/kg every 12 hours. Patients were treated according to available local and international guidelines;corticosteroids and anticoagulation were administered when not contraindicated. Results are described by median (IQR) or frequency (%);P-values (P) were calculated by chi-square or Fishers' exact test and Wilcoxon rank-sum test, as appropriate. Survival estimates at 28 days were calculated using Kaplan-Meier curves. Results: At hospital admission (Table 1), patients treated with REM+ANK tended to be older [69 years (57-77) vs 62 years (53-75), P=0.06], had a significant lower PaO2/FiO2 [135 (91-220) vs 246 (172-299), P=0.0001], higher aspartate aminotransferase [51U/L (34-74) vs 40U/L (30-53), P=0.001], lactate dehydrogenase [405U/L (296-496) vs 334U/L (279-419), P=0.008], D-dimer [0.86mcg/mL (0.48-1.57) vs 0.67mcg/mL (0.39-1.17), P=0.048], ferritin [1167ng/mL (804-1983) vs 683ng/mL (391-1153), P<0.0001] and C-reactive protein [82mg/L (38-136) vs 58 mg/L (27-96), P=0.004), and were more frequently admitted to the Intensive Care Unit within the first 48 hours [3 (1.1%) vs 0, P=0.007). REM and ANK were started early within a median of 0 (0-2) and 1.5 days (0-3) since hospitalization, respectively. The Kaplan-Meier estimate of mortality at 28 days was 17.2% (95%CI 8.8-32.1%) in the REM+ANK group (8 deaths) and 21.4% (95%CI 13.3-33.3%) in the REM group (18 deaths;log-rank test P=0.797). Median time to death was 14 days (9-29) in the REM+ANK group vs 19 days (12-27) in the REM group (P=0.523). Conclusion: Real-life use of high-dose ANK in COVID-19 patients treated with REM was reserved for subjects with severe respiratory failure and a more pronounced inflammatory status. Nevertheless, mortality at 28 days was not significantly different among patients treated with or without ANK. Further analyses are warranted to verify the impact of ANK addition to REM in patients with a hyperinflammatory profile.

17.
Topics in Antiviral Medicine ; 30(1 SUPPL):303, 2022.
Article in English | EMBASE | ID: covidwho-1879900

ABSTRACT

Background: Reinfections with emerging SARS-CoV-2 variants are a serious concern. This study estimated the efficacy of immunity induced by natural infection against reinfection with B.1.351 and B.1.1.7 variants. Methods: Two retrospective matched cohort studies were conducted in Qatar from March 8-April 21 to assess reinfection in the national cohort of individuals with a prior PCR-confirmed infection and the national cohort of antibody-positive individuals, matching each in a 1:1 ratio by demographic characteristics to the national cohort of antibody-negative individuals. Incidence risks (using the Kaplan-Meier estimator), incidence rates, and efficacy of natural infection against reinfection were estimated. Results: In the study comparing 44,821 individuals with a prior PCR-confirmed infection to antibody-negative individuals, the efficacy of natural infection against reinfection was 92.3% (95% CI: 90.3-93.8%) for B.1.351, 97.6% (95% CI: 95.7-98.7%) for B.1.1.7, and 87.9% (95% CI: 84.7-90.5%) for unidentified variants (mostly suspected B.1.351 cases based on weekly sequencing analysis). In the second study, comparing 20,406 antibody-positive to antibody-negative individuals, efficacy was 86.4% (95% CI: 82.5-89.5%) for B.1.351, 96.4% (95% CI: 92.1-98.3%) for B.1.1.7, and 83.1% (95% CI: 77.2-87.5%) for unidentified variants. Additional analyses and sensitivity analyses confirmed these results, albeit with slightly lower efficacies. Conclusion: Natural infection with SARS-CoV-2 induces robust protection of 80-90% against reinfection with B.1.351 even a year after the primary infection, but lower than that against B.1.1.7.

18.
Topics in Antiviral Medicine ; 30(1 SUPPL):46, 2022.
Article in English | EMBASE | ID: covidwho-1879897

ABSTRACT

Background: Neutralizing antibodies are recognized as a principal correlate for protection induced by SARS-CoV-2 vaccines and have been considered for antiviral treatment as an active component in convalescent plasma therapy (CPT) and as monoclonal antibody therapeutics. However, unless used at a very early stage of infection, antibody-based SARS-CoV-2 therapies have not achieved the substantial disease-modulating effect hoped for. Methods: Here, we conducted a proof-of-principle study of CPT based on a phase I trial in thirty hospitalized COVID-19 patients with a median interval between the onset of symptoms and the first transfusion of 9 days (IQR, 7-11.8 days). A comprehensive longitudinal monitoring of the virologic, serologic, and disease status of recipients in conjunction with detailed post-hoc seroprofiling of transfused convalescent plasma allowed deciphering of parameters on which plasma therapy efficacy depends. Results: In this study, CPT was safe as evidenced by the absence of transfusion-related adverse events. We also observed an overall low mortality (3.3%). Treatment with highly neutralizing plasma was significantly associated with faster virus clearance, as demonstrated by Kaplan-Meier analysis (p = 0.034) and confirmed in a parametric survival model including viral load and comorbidity (adjusted hazard ratio (HR) = 3.0 [95% confidence interval (CI) 1.1;8.1], p = 0.026) (Figure 1). Endogenous immunity had strong effects on virus control. Lack of endogenous neutralizing activity at baseline was associated with a higher risk of systemic viremia. The onset of endogenous neutralization had a noticeable effect on viral clearance but, importantly, even after adjusting for their endogenous neutralization status recipients benefitted from plasma therapy with high neutralizing antibodies (HR= 4.0 [95% CI 1.3;13], p = 0.017). Conclusion: In summary, our data demonstrate a clear impact of neutralizing antibody therapeutics on the rapid clearance of viremia and with this provide directions for improved efficacy evaluation of current and future SARS-CoV-2 therapies beyond antibody-based interventions. In particular, incorporating an assessment of the endogenous immune response and its dynamic interplay with viral production is critical for determining therapeutic effect.

19.
European Heart Journal Cardiovascular Imaging ; 23(SUPPL 1):i103-i104, 2022.
Article in English | EMBASE | ID: covidwho-1795326

ABSTRACT

Introduction: Myocardial damage has been widely described in patients with COVID-19. Right ventriculoarterial coupling (RVAC) is a marker of subclinical myocardial damage. The association with mortality in COVID-19 patients has been recently investigated. Objectives: To determine if there is a difference in patients with abnormal vs normal RVAC, in clinical, laboratory and echocardiographic variables. Analyze if there is an association between the presence of abnormal RVAC and one-year mortality. Investigate the cutoff value of the RVAC to predict mortality. Methods.: A single-center, prospective, analytical study. Patients with a diagnosis of COVID-19 were included. Patients who were on mechanical ventilation during the study, a history of ischemic heart disease, valvular heart disease, and chronic obstructive pulmonary disease were excluded. The patients were included during the period from May to August 2020, the 1-year follow-up was carried out through the electronic medical record and telephone calls. The echocardiograms were performed with the Phillips IE-33, the strain determination was obtained with the Qlab 13.0 software. The quantitative variables were compared with the Student's T test or the U Mann-Whitney test, according to the normality of the variables;qualitative variables were contrasted with the x2 test. One-year survival was determined with the Kaplan-Meier curves, and the association with one-year mortality was investigated with Cox regression. The cut-off value for predicting mortality was determined with ROC curves. The RVAC was determined with the right ventricular free wall longitudinal strain / pulmonary systolic artery pressure ratio. Abnormal right ventriculoarterial coupling was determined with a value less than 0.8. Results: 81 patients were included, of whom 45 had an abnormal RVAC. Patients with abnormal RVAC had higher mortality and a higher requirement for mechanical ventilation;they had higher levels of biomarkers. Among the echocardiographic variables, they had lower the right ventricular fractional area change, the tricuspid annular plane systolic excursion, the left ventricular longitudinal strain, the left atrial reservoir strain, the right ventricular free wall longitudinal strain, the RVAC;while they also presented higher the pulmonary systolic artery pressure and the tricuspid regurgitation velocity. The one-year survival of patients with abnormal RVAC was 53% vs 91%, the association with 1-year mortality was HR: 7.0 (CI95 2.1-23;p = 0.0001). The cutoff value of the RVAC to predict mortality was <0.48 (Sensitivity 71%, Specificity 90%, AUC: 0.836;p = <0.0001). Conclusion: The patients with COVID-19 and an abnormal RVAC had a higher requirement for mechanical ventilation and mortality;presented higher levels of biomarkers. Half of the patients with abnormal RVAC died, presenting an association to predict mortality. The cut-off value of <0.48 was the best associated with mortality.

20.
Open Forum Infectious Diseases ; 8(SUPPL 1):S27-S28, 2021.
Article in English | EMBASE | ID: covidwho-1746801

ABSTRACT

Background. Remdesivir (RDV) reduced time to recovery and mortality in some subgroups of hospitalized patients in the NIAID ACTT-1 RCT compared to placebo. Comparative effectiveness data in clinical practice are limited. Methods. Using the Premier Healthcare Database, we compared survival for adult non-mechanically ventilated hospitalized COVID-19 patients between Aug-Nov 2020 and treated with RDV within 2 days of hospitalization vs. those who did not receive RDV. Preferential within-hospital propensity score matching with replacement was used. Patients were matched on baseline O2 and 2-month admission period and were excluded if discharged within 3 days of RDV initiation (to exclude anticipated discharges/transfers within 72 hrs consistent with ACTT-1 study). Time to 14- and 28-day mortality was examined separately for patients on high-flow/non-invasive ventilation (NIV), low-flow, and no supplemental O2 using Cox Proportional Hazards models. Results. RDV patients (n=27,559) were matched to unique non-RDV patients (n=15,617) (Fig 1). The two groups were balanced;median age 66 yrs and 73% white (RDV);68 yrs and 74% white (non-RDV), and 55% male. At baseline, 21% required high-flow O2, 50% low-flow O2, and 29% no O2, overall. Mortality in RDV patients was 9.6% and 13.8% on days 14 and 28, respectively. For non-RDV patients, mortality was 14.0% and 17.3% on days 14 and 28, respectively. Kaplan-Meier curves for time to mortality are shown in Fig 2. After adjusting for baseline and clinical covariates, RDV patients on no O2 and low-flow O2 had a significantly lower risk of death within 14 days (no O2, HR: 0.69, 95% CI: 0.57-0.83;low-flow, HR: 0.67, 95% CI: 0.59-0.77) and 28 days (no O2, HR: 0.80, 95% CI: 0.68-0.94;low-flow, HR: 0.76, 95% CI: 0.68-0.86). Additionally, RDV patients on high-flow O2/NIV had a significantly lower risk of death within 14 days (HR: 0.81, 95% CI: 0.70-0.93);but not at 28 days (Fig 3). Conclusion. In this large study of patients in clinical care hospitalized with COVID-19, we observed a significant reduction of mortality in RDV vs. non-RDV treated patients in those on no O2 or low-flow O2. Mortality reduction was also seen in patients on high-flow O2 at day 14, but not day 28. These data support the use of RDV early in the course of COVID-19 in hospitalized patients.

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