Isopp 2023

The proceedings contain 109 papers. The topics discussed include: dose intensity of palbociclib and initial body weight dosage: implications on progression free survival in 220 patients with ER+/HER2-negative metastatic breast cancer;characteristics of Nirmatrelvir/Ritonavir (Paxlovid) recipients and clinical interventions by oncology pharmacists at a tertiary outpatient cancer center;safe handling of non-carcinogenic drugs in the Ghent University Hospital: development, implementation and communication of hospital-specific guidelines;case series: use of olaparib in uncommon locations in patients with impaired homologous recombination;real-world data evaluation of medicines used in special situations in oncohematology: a retrospective study from a comprehensive cancer institution;Dostarlimab in the treatment of recurrent endometrial cancer: real life experience;medication-related osteonecrosis of the jaws and CDK4/6 inhibitors in breast cancer;and efficacy and safety outcomes of generic imatinib in adults with chronic myeloid leukemia (CML) following the switch from branded imatinib.

Risk factors for COVID-19 incidence and mortality in patients on maintenance hemodialysis

Patients on maintenance hemodialysis (MHD) are highly susceptible to SARS-CoV-2 and with high mortality rates due to Coronavirus disease 2019, mainly because of the older age in this group of patients, comorbidities, compromised immune status due to uremia, as well as inability to keep social isolation because of the necessity for regular physical presence in dialysis facility. Several retrospective studies of patients on MHD in Europe, America and Asia, show high susceptibility to SARS-CoV-2 in this group of patients with very high rates of critical course of the disease and high mortality rates, reaching more than 40% The aim of this retrospective observational study was to identify risk factors among patients on intermittent hemodialysis for infection with SARS-CoV-2 as well as predictors of severe COVID-19 and fatal outcome. Materials and methods. We analyzed 69 patients receiving intermittent dialysis in Aleksandrovska University Hospital - Hemodialysis Unit. 34 of them have been tested positive for SARS-CoV-2 in the period from September 2020 (when the first case of the disease was registered for our dialysis center) up to March 2022, and are compared with a control group of 35 dialysis-dependent patients without COVID-19. Data about comorbidities, main laboratory and radiologic findings, need of hospitalization and treatment in ICU, as well as data for conducted treatment, are collected from electronic medical records. To identify predictors of severe COVID and poor outcome we compared the group of survivors with the one of non-survivors. Results. There are no significant differences between patients on MHD with and without COVID-19 except higher frequency of COPD and hypoproteinemia in the positive group. Older age, female gender, history of smoking, lymphopenia with neutrophilia, treatment in ICU and need of mechanical ventilation, signs of malnutrition - hypoproteinemia and lower levels of serum creatinine, are risk factors for severe disease and fatal outcomes. Conclusions. The course of COVID infection in dialysis-dependent patients is severe and with high mortality rate, in line with other studies worldwide. Malnutrition is the main risk factor for COVID and also main predictor for poor outcomes.

Parameters of coagulation in COVID-19 patients: a correlation with clinical severity

Introduction: COVID-19 infection can be complicated by coagulation derangement and a high risk of thromboembolic episodes. Our study aimedto investigate coagulation parameters in COVID-19 patients and their correlation with clinical severity. Methods: We analyzed coagulation parameters PT, APTT, D-Dimer, and Fibrinogen in 98 RT-PCR-confirmed COVID-19 patients admitted to the Government Institute of Medical Sciences, Gautam Buddha Nagar, Uttar Pradesh, India. Results: This study involved 69 males (70.50%), and 29 (29.5%) were females. The mortality rate was 6.12% (n= 06). Forty-six patients (46.94%) had comorbidities. Thirty-four patients had elevated PT, and 7 had high APTT, whereas D-dimer and fibrinogen levels were raised in 68 and 61 patients, respectively. Among all four parameters, D-Dimer levels were significantly associated with disease severity. Conclusion: Derangement of D-dimer levels is significantly associated with disease severity in COVID-19 infection.

The Impact of the Sars-Cov-2 Pandemic (COVID-19) on the Incidence of Newly Diagnosed Multiple Myeloma Patients Using a Federated Network of Real-World Evidence in US and Germany

Objectives: COVID-19 had an impact on health care, including diagnostics. Early diagnosis of MM is a critical factor for prognosis. We examined the impact of COVID-19 on incidence of NDMM patients and on characteristics in NDMM patients in US and in Germany. Method(s): 44,164 NDMM patients were identified in TriNetX federated network across 55 healthcare organizations in US between January 2018 and December 2021. A bivariate analysis examined changes in patient characteristics in two cohorts before (Cohort 1;n=25513) and after (Cohort 2;n=18.651) the start of the COVID-19 pandemic in March 2020. 4172 NDMM patients were identified in the German database in a sample of across >100 healthcare organizations in the same time period. Similarly, bivariate analysis examined changes in patient characteristics before (Cohort 1;n=2252) and after (Cohort 2;n=1920) the start of pandemic. Result(s): Analysis of US data showed a significant decrease in incidence of NDMM. Bivariate analysis revealed that NDMM patients in Cohort 2 have a significantly higher risk profile compared with patients in Cohort 1, higher incidence of renal failure (13.5% v. 15.43%), heart failure (10.3% v 11.26%), bone lesions (12.6% v. 13.05%) and anemia (26.8% v. 29.75%). The German data indicated an increased risk profile in Cohort 2, with higher reporting of renal impairment (12.3% v. 15.5%) and cardiac impairment (8.3% v. 10.9%). The higher risk profile was reflected in a significant increase of all SLiM-CRAB criteria, notably hypercalcemia (24.1 % v. 36.9%), bone marrow plasma cell infiltration (28.1% v. 36.8%) and free light chain involvement (27.3% v. 41.3%). Conclusion(s): The results provide real-world evidence of a change in risk profile for patients with NDMM during COVID-19. This higher risk profile is observed in both the US and Germany, and may negatively impact outcomes such as progression-free and five-year overall survival.Copyright © 2023

Assessment of liver function in COVID-19

Introduction: COVID-19 is an infectious disease caused by the SARS-CoV-2 virus that commonly involved the respiratory system. However, the virus can affect any organ in the body including the liver. Hepatic involvement in COVID-19 could be related to the direct cytopathic effect of the virus, an uncontrolled immune reaction, sepsis, or drug-induced liver injury. Background: The current study aims to evaluate the relevance of liver enzyme derangement in COVID-19. Methods: The sample size of 165 patients, tested positive for covid 19 and underwent liver enzyme testing. These patients were categorized into mild, severe, and critical diseases based on clinical evaluation, radiological findings, and biochemical parameters. Results: Of 165 patients selected 103 (62.4%) have mild disease, 40(24.2%) have severe and 12(7.2%) suffered from the critical disease. 48(29.1%) patients show deranged liver function. 83.3% of critical patients and 45% of severe patients show deranged liver function.9.09%of patients died due to severe COVID-19 infections showing moderately to severe liver function derangement. Conclusions: This study concludes that the severity of COVID-19 disease may increase due to chronic liver disease, particularly fatty liver. Atypical ALT and AST levels during hospitalization were indicative of liver injury and correlated with the severity of patients.

Oesophageal and oral ulcer tuberculous associated with human T-cell lymphotropic virus type 1 (HTLV-1) and SARS-CoV-2 infection

Oesophageal involvement due to tuberculosis (TB) and coinfection with HTLV-1 is rare and can be complicated by the presence of other infections that affect the mucosa of the upper respiratory tract, such as COVID-19. We present the case of a 27-year-old male patient, with 3 months of illness, weight loss, dysphagia, and ulcers in the oral cavity. Tomography showed oesophageal perforation and after oesophageal ulcer biopsy, TB was diagnosed, in addition to infection by HTLV-1 and severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). The patient responded satisfactorily to antituberculous treatment and corticosteroids. Considering the association between rare extrapulmonary tuberculosis and other immunosuppressive pathologies, it is crucial to identify these pathologies in such patients.

The role of hemostatic system and the importance of blood coagulation in COVID-19: a review study

Background and Aim: Coronavirus disease 2019 (COVID-19) is a respiratory disorder that can affect many body systems, including the hemostatic system. In this study, we aim to investigate the role of hemostatic system and the blood coagulation in COVID-19. Methods & Materials In this review study, the articles were searched using the keywords COVID-19, Respiratory infection, and Coagulopathy in Google Scholar, PubMed, Google Springer and Science Direct databases. Ethical Considerations: Ethical principles in writing this article were observed in accordance with the guidelines of the National Ethics Committee and the Committee on Publication Ethics (COPE). Results Many changes in the coagulation profile of infected patients were reported, including changes in the platelet count, fibrinogen/fibrin degradation product, D-Dimer, fibrinogen, prothrombin time, and activated partial thromboplastin time. With the increase in the number of patients with COVID-19, several studies found out the occurrence of thrombosis and coagulopathy in patients. Conclusion: Due to the increase in the occurrence of coagulation disorders in patients with COVID-19, the administration of anticoagulants is needed for their treatment;it can play an effective role in improving the prognosis of patients.

COVID-19: our experience and quality of management analysis: (Topolsica Hospital case report)

Various Slovenian hospitals were recruited to treat COVID-19 patients in Slovenia during the COVID-19 epidemic. Centrally coordinated hospital utilisation - depending on the needs, available hospital bed capacity, and considering the professional orientation of individual hospitals - left these facilities with different experiences. We present our experience and COVID-19 treatment management during the fourth epidemic wave in our peripheral, pulmonary-oriented hospital, representing the first treatment quality analysis of these patients in Slovenia. The basic hospitalization characteristics were analysed using integrated Birpis information system solutions and the electronic temperature-therapeutic charts (eTTL) review. The quality of management was assessed through adherence to professional recommendations. The analysis was carried out with the in-built statistical functions of Microsoft Excel software. 99 patients (58 women, 41 men) aged 67.9 years were hospitalised for an average of 8.1 days. The majority were residents of our region (61%), unvaccinated (61.6%), and experienced a severe form of the disease with the need for oxygen supplementation (88.9%). The majority received steroids (73.7%), antibiotics (68.7%) and vitamin D (71.7%), to a lesser extent specific therapy (remdesivir 25.3%, combination casirivimab/imdevimab 2%, tocilizumab 1%). No adverse reactions were noted. 17 people died (total mortality rate 17.2%). There was no infection transmission among the COVID department staff. Results show successful treatment of patients with COVID-19 in Topolsica Hospital. They also suggest the possibility of further improvements, particularly in prescribing antibiotic therapy.

Creation and implementation of the SIENMECRO chronic patient drug delivery system: qualitative study

Introduction: Faced with the pandemic produced by SARS-CoV-2, the Peruvian government implemented several measures such as the temporary closure of primary care facilities and the health system implemented various policies and strategies;one of them was to create and implement the Drug Delivery System for Chronic Patients (SIENMECRO) project. Background: To describe the creation and implementation process of SIENMECRO project. Methods: Qualitative case study that involved reviewing existing documentation such as texts and videos and conducting in-depth interviews with officials and collaborators involved since the preparation of SIENMECRO proposal. Results: SIENMECRO project emerges as a positive initiative with the aspiration of promoting an integrated health system that addresses the health reality from the social determinants of health, due to patients' difficulties to go to their controls and to receive their treatment. Although there was no comprehensive plan for the implementation and control of the project, it was essential to cover the need for health care for a vulnerable segment of the population, avoiding their transfer and preserving the health of the people most likely to suffer complications from COVID-19 infection. Conclusions: It is an initiative where the health system takes a more proactive role for the benefit of the population, implementing the use of technology of the information and communication in health care, articulating with the various providers and bringing services closer to the most vulnerable citizens.

Association of state-level COVID-19 mortality rates with real-world progression and real-world overall survival among patients with advanced non-small cell lung cancer, 2020-2022

Background: The COVID-19 pandemic impacted the delivery of cancer care and outcomes in the United States (US). We examined the association between time-varying state-level weekly COVID19 mortality and progression-free survival (rwPFS), time to progression (rwTTP), and survival (rwOS) among pts with advanced non-small cell lung cancer (advNSCLC). Method(s): This retrospective study used the nationwide Flatiron Health electronic health recordderived de-identified database. The cohort included community oncology pts diagnosed with advNSCLC between March 1, 2020 and December 31, 2021 (follow-up through March 30, 2022). We extracted US data on COVID-19 deaths from the COVID-19 Data Repository by the Center for Systems Science and Engineering at Johns Hopkins University. We calculated state-level weekly COVID-19 death rates as weekly COVID-19 deaths per state population size from the 2019 American Community Survey. We categorized rates into quintiles based on all weekly rates during the observation period. Analyses were restricted to treated pts and indexed to start of first-line therapy. For rwPFS analyses, first occurrence of progression or death was considered an event, and pts were censored at last clinic note date. For rwTTP, only progression (not death) was considered an event, and pts with no event were censored at last clinic note date. For rwOS analyses, pts who did not die were censored at last structured activity. We used Cox proportional hazards models to estimate hazard ratios (HR) and 95% confidence intervals (CI) for associations between weekly time-varying state-level COVID-19 mortality rates and outcomes of rwPFS, rwTTP, and rwOS, adjusted for age at diagnosis, race/ethnicity, and state. Result(s): Among 7,813 advNSCLC pts, the median age at diagnosis was 70 years, the majority of the cohort was non-Hispanic White (59%), had non-squamous cell histology (68%) and a history of smoking (87%). Compared to pts living in states with the lowest quintile of COVID-19 mortality rates (Q1), pts living in states with the highest COVID-19 mortality (Q5) had worse rwOS (Q5 vs. Q1: HR 1.46, 95% CI 1.26-1.69) and rwPFS (Q5 vs. Q1: HR 1.18, 95% CI 1.05-1.33). No association was observed with rwTTP (Q5 vs. Q1: HR 1.05, 95% CI 0.90-1.22). Conclusion(s): In this study of real-world oncology data, we demonstrated the use of publicly-available COVID-19 mortality data to measure the time-varying impact of COVID-19 severity on outcomes in pts with advNSCLC. Higher state-level COVID-19 mortality rates were associated with worse rwOS and rwPFS among advNSCLC pts. The association with increased mortality among pts with advNSCLC may be related to COVID-19-related mortality or other factors such as pre-existing comorbidities which were not explored in this study.

Scenarios of COVID-19 epidemic effects on socioeconomic and health status of Iran

Background and Objectives: The COVID-19 epidemic and its subsequent effects have become a significant global challenge. In addition to being affected by this crisis, Iran is also facing many other problems, including sanctions and economic problems. So, there is a concern that it will suffer more severe consequences. Methods: Scenario planning is one of the ways to recognize future changes and environmental uncertainties. This study used the so-called global business network (GBN) method, also known as the scenario matrix method. This method is based on two key uncertainties and six steps have been taken to examine variables related to health and socio-economic factors and use the opinions of relevant experts. Results: To be expected, Iran's health system will be able to manage the epidemic in the face of various conditions with severity and weakness, and only in the pessimistic scenario or in Worst-case scenario with the default assumption of the continuation of sanctions and the spread of the epidemic. It leads to global restrictions, loss of foreign exchange reserves, loss of performance or collapse of the health system, increasing the number of deaths and diminishing the quality of life. Conclusion: Regarding the COVID-19 epidemic and the existing background factors, scenarios of Iran's health and economic conditions were narrated. Given the ability of the scenarios to understand the complexity and help in decision-making, it is considered a useful tool for policy makers to have a broader, comprehensive and reasonable look to achieve a correct consensus. This situation leads to the preservation and continuation of society health and conventional economic decisions.

Spectrum of echocardiographic findings in patients with severe and critical COVID-19: a single center experience

Introduction: Information on the cardiac manifestations of coronavirus disease 2019 (COVID-19) is scarce. In this study we assessed the echocardiogram of consecutive patients with COVID-19 infection to assess the frequency of cardiac abnormalities. Materials and Methods: This retrospective descriptive study examined the echocardiographic study of 43 patients with severe and critical COVID-19 infection admitted at the ICU of Chitwan Medical College from May 16, 2021 to June 05, 2021. The study focused on left ventricle (LV) and right ventricle (RV) function. The results were then compared between severe and critical infections to examine if any differences exist between them. Results: The mean age of the study population was 54 years and predominately males. One-third were classified as critical COVID-19 while the remaining were severe COVID-19. Majority(83.7%) had a normal echocardiogram. Among the patients with abnormal reports, the distribution of echocardiographic pattern were biventricular dilation with biventricular dysfunction in two patients (4.6%), LV dialtion with LV dysfunction in two patients (4.6%) and isolated LV dysfunction (diastolic and systolic) in three patients (6.9%). None of the echocardiographic parameters were significantly different between the severe and the critical infection. Conclusion: COVID-19 in primarily a respiratory disease and the cardiac complications is largely attributed to the critical nature of the illness than the specific infection. Considering the risk of infection spread, routine echocardiography for all patients with COVID-19 infection is not advisable.

Comparison of laboratory parameters during herpes zoster infection: a case-control study

Objective: We aimed to find the parameters that can change during herpes zoster infection and observe the relationship of these parameters throughout the disease. Material and Methods: We compared 40 herpes zoster patients and 2 separate control groups, who were healthy and had comorbidities similar in age and gender. Patient files were retrospectively analyzed, and laboratory parameters were compared between groups. The laboratory values of the patient group with herpes zoster were evaluated among themselves according to the duration of the symptoms. Results: Fasting glucose, creatinine, aspartate aminotransferase values, the percentage and the absolute number of monocytes, red blood cell distribution width-coefficient of variation, and C-reactive protein levels of the patients with herpes zoster were significantly higher, and the absolute number of lymphocytes, mean corpuscular volume and platelet distribution width levels were lower than the control groups. The percentage of monocytes in the first 5 days was significantly higher than in the following days, and hematocrit values were lower in the last days. Conclusion: Examining routine laboratory values during diseases may help diagnose the disease, especially in patients with faint clinical signs and zoster sine zoster. In addition, it may be useful to question patients with herpes zoster for renal dysfunction, rheumatological diseases, and malignancy.

Retrospective nested study of demographic characteristics, lethality and discharge rate of COVID-19 inpatients in central south of Bulgaria

Introduction: SARS-CoV-2 infection has affected more than 683 million people worldwide with 6.8 million deaths. Unfortunately, Bulgaria is one of the most severely affected European Union (EU) member-states with one of the highest mortality rates. Aim: The study aims to provide a description of the demographic characteristics, discharge rate, and fatality rate of COVID-19-diagnosed patients in one region of Central South Bulgaria in 2021. Materials and methods: A retrospective nested case series study was conducted among patients hospitalized with a confirmed diagnosis of SARS-CoV-2 infection between January 1st and December 31st, 2021. Anonymized patient data on age, sex, admission and discharge dates, treatment, and the outcome was collected from hospital electronic patient records and analyzed using descriptive statistics. Results: Data from 1630 (51% male) patients were identified. The mean age was 63.64 years (+or-15.23). 1342 (82%) of the patients were discharged. The mean age of the diseased was 70.88 years (+or-10.05). 1455 (89%) patients received only symptomatic therapy, 155 (10%) patients were treated with remdesivir (VekluryR), 11 (1%) patients were treated with casirivimab/imdevimab (RonapreveR) and 9 (1%) patients were administered regdanvimab (RegkironaR). Conclusions: The study results demonstrate that Bulgarian patients with COVID-19 were treated according to the best global and national evidencebased guidelines. Lethality and discharge rates are in concordance with global trends and outcomes.

The impact of coronavirus (COVID-19) on fruit consumption

Covid-19 is a global pandemic that has an impact on all sectors, when compared to consumption in the period before and after, the consumption of fruit in the province of North Sumatra has decreased but there has been an increase in the average monthly per capita expenditure (rupiah) of fruit commodities. This study aims to analyze the factors that influence people's consumption of fruit in the city of Medan and the impact of the coronavirus (covid-19) on fruit consumption in the city of Medan. The research method used is the case study method. The method of determining the research area used is purposive and the data used are primary data obtained through interviews with 100 respondents. The results of the analysis show that the factors that influence consumption patterns include income, number of family members, age, and education have a significant effect simultaneously on the amount of fruit consumption. Income, number of family members and education partially affect the amount of fruit consumption, while the age variable has no significant effect partially on the amount of fruit consumption. Based on the results of hypothesis testing, it can be concluded that the Covid-19 virus affects the amount of fruit consumption in the city of Medan. Fruit consumption in Medan before, during and after the Covid-19 virus is different. With the Covid-19 pandemic, health and body immunity are very important to maintain their performance. Ways to maintain health during the pandemic, ranging from wearing masks, washing hands with soap to consuming vitamins and minerals that can be obtained from consuming fruits.

Drug utilization study in patients affected with COVID-19 in a dedicated COVID hospital

Background: There exists a treatment dilemma regarding the optimal and effective use of therapeutic drugs (hydroxychloroquine/chloroquine/azithromycin) for COVID-19. Furthermore, with changing guidelines, the data on drug utilization patterns across India are limited. Hence, this study was conducted to assess the prescription pattern and drug utilization trends in COVID-19 patients with the aim to study the drug utilization pattern in patients affected with COVID-19 in a dedicated COVID-19 hospital. Aims and Objectives: The objectives of the study are as follows: (1) To study drug utilization patterns according to the severity of the disease. (2) To study the prevalence of adverse drug reactions (ADRs). Materials and Methods: Data were collected retrospectively from 100 medical records of patients 18 years irrespective of sex admitted in the COVID ward and ICU of a dedicated COVID hospital from May to August 2020. Pregnant and lactating women were excluded from the study. ADRs reported were also analyzed. Results: About 71% were mild in this study, 18% were moderate, and 11% were severe COVID-19 patients. Overall, the most common drugs prescribed were multivitamins, followed by pantoprazole, paracetamol, and azithromycin. Hydroxychloroquine was prescribed in 22%, favipiravir in 7%, and remdesivir in 3% of cases. The majority of moderate COVID patients received injectables piperacillin-tazobactam, methylprednisolone, and enoxaparin. The mean number of medications, duration of admission, and number of days on oxygen were higher and significant in moderate compared to mild and severe COVID patients. Overall, ADRs were encountered in 9% of cases. Conclusion: The prescribed pattern of drugs was by the national standard guidelines. Multivitamins, followed by pantoprazole, paracetamol, and azithromycin dominated the prescription pattern. Polypharmacy was encountered, which needs to be addressed for the rational use of drugs.

Molnupiravir and combination of nirmatrelvir and ritonavir (PaxlovidTM) - oral anti-viral drugs in COVID-19: a systematic review

The COVID-19 pandemic situation demands the discovery of newer drugs and/ or repurposing of the existing drugs. The anti-viral drugs approved for COVID-19 are remdesivir and favipiravir. Two more directly acting oral anti-viral drugs have been granted Emergency Use Authorization by US-FDA, molnupiravir on December 23, 2021, and nirmatrelvir and ritonavir (PaxlovidTM) on December 22, 2021. Molnupiravir, an RNA-dependent RNA polymerase (RdRp) inhibitor, has also been approved in the UK and is under review with other regulatory agencies. PaxlovidTM (a combination of the new anti-viral drugs nirmatrelvir and ritonavir) has been developed and approved by US-FDA and CDSCO, India. Nirmatrelvir acts by inhibiting 3CL (chymotrypsin-like) protease enzyme and it is combined with ritonavir to slow down its breakdown by cytochrome P450 enzymes and to increase the bioavailability. Both molnupiravir and PaxlovidTM have been approved for mild and moderate COVID-19 and in patients who have a higher risk of disease progression to severe disease including hospitalisation and death. This article systematically reviews the clinical trials of molnupiravir and PaxlovidTM that evaluated their efficacy and safety against COVID-19 in both published and unpublished literature.

Special issue: The role of laboratory medicine in predicting the survival, progression and mortality of patients with corona virus disease 2019 (Covid-19). (Special issue: The role of laboratory medicine in predicting the survival, progression and mortality of patients with corona virus disease 2019 (Covid-19).)

This special issue contains 8 articles that explore various latest research on COVID-19, including the clinical presentation of the disease, the role of inflammation, the development of new treatments, and the long-term effects of the infection. The topics covered include the evaluation of white blood cell parameters and their significance in COVID-19 patients in Western Maharashtra, India;the association between acute phase reactants and COVID-19 severity and mortality in a tertiary care hospital in India;the clinico-hematological profile of COVID-19 patients from an Indian perspective;the correlation between C-reactive protein test results and clinical characteristics in COVID-19 patients;the effective binding affinity of an inhibitor against the SARS-CoV-2 NSP13 helicase;the assessment of absolute neutrophil count in COVID-19 patients in a tertiary care hospital;the analysis of the anti-SARS-CoV-2 IgG response following the first and second dose of a COVID-19 vaccine;and a case report discussing the diagnostic dilemma of hypoplastic acute myeloid leukemia in a COVID-19 patient.

Efficacy of Remdesivir and Neutralizing Monoclonal Antibodies in Monotherapy or Combination Therapy in Reducing the Risk of Disease Progression in Elderly or Immunocompromised Hosts Hospitalized for COVID-19: A Single Center Retrospective Study.

INTRODUCTION: Remdesivir (REM) and monoclonal antibodies (mAbs) could alleviate severe COVID-19 in at-risk outpatients. However, data on their use in hospitalized patients, particularly in elderly or immunocompromised hosts, are lacking. METHODS: All consecutive patients hospitalized with COVID-19 at our unit from 1 July 2021 to 15 March 2022 were retrospectively enrolled. The primary outcome was the progression to severe COVID-19 (P/F < 200). Descriptive statistics, a Cox univariate-multivariate model, and an inverse probability treatment-weighted (IPTW) analysis were performed. RESULTS: Overall, 331 subjects were included; their median (q1-q3) age was 71 (51-80) years, and they were males in 52% of the cases. Of them, 78 (23%) developed severe COVID-19. All-cause in-hospital mortality was 14%; it was higher in those with disease progression (36% vs. 7%, p < 0.001). REM and mAbs resulted in a 7% (95%CI = 3-11%) and 14% (95%CI = 3-25%) reduction in the risk of severe COVID-19, respectively, after adjusting the analysis with the IPTW. In addition, by evaluating only immunocompromised hosts, the combination of REM and mAbs was associated with a significantly lower incidence of severe COVID-19 (aHR = 0.06, 95%CI = 0.02-0.77) when compared with monotherapy. CONCLUSIONS: REM and mAbs may reduce the risk of COVID-19 progression in hospitalized patients. Importantly, in immunocompromised hosts, the combination of mAbs and REM may be beneficial.