Differences in Disease Burden and Treatment Utilization By Socioeconomic Status Among a Large Cohort of Patients with COVID-19 Diagnosis in the United States

Objectives: Social determinants of health (SDoH) including income, education, employment, and housing are known to affect health outcomes;while use in real-world database studies are limited. This study assessed socioeconomic differences in burden of disease and utilization of COVID-19 specific medications in a large cohort of patients in the US. Method(s): A total of 17,682,111 patients having a COVID-19 diagnosis between 4/1/2020 and 4/30/2022 were identified in the IQVIA longitudinal medical and pharmacy claims databases of >277 million patients. For SDoH, a 3-digit zip code median Area Deprivation Index (ADI) (v2.0 University of Wisconsin School of Medicine and Public Health 2015) was calculated for each patient, maintaining patient privacy. The ADI is a validated tool ranking neighborhoods by socioeconomic disadvantage. Medical and pharmacy utilization was assessed and stratified by ADI pentiles, where 0-20 was the least disadvantaged, and 81-100 was the most disadvantaged. Result(s): The proportion of patients having a claim with COVID-19 diagnosis was higher in the most disadvantaged (7.75%) compared to the least disadvantaged group (5.94%) (US overall: 6.37%). Medical claims prior to COVID-19 diagnosis were highest in the least disadvantaged, while prior pharmacy utilization was highest in the most-disadvantaged group. There was sparse use of COVID-19 medications overall;the least disadvantaged patients had the lowest use of COVID-19 specific medications. Casirivimab/imdevimab use was highest in the 61-80 (2.01%) and 81-100 (1.79%) ADI groups, and remdesivir use was highest in the moderately disadvantaged (ADI 41-60 and 61-80) groups (both 2.33%). Utilization of hydroxychloroquine (unapproved for COVID-19) increased from 0.91% in the least to 2.13% in the most disadvantaged groups. Conclusion(s): This study shows unequal burden of COVID-19 prevalence by SDoH, with the most disadvantaged having a higher disease burden and utilization of certain approved and unapproved COVID-19 medications, highlighting the need for further study of the reasons for these disparities.Copyright © 2023

Variation in Demographic Characteristics, Socioeconomic Status, Clinical Presentation and Selected Treatments in Mortality Among Patients with a Diagnosis of COVID-19 in the United States

Objectives: COVID-19 infected over 150 million people and caused over 1 million deaths in the US. This study evaluates several variables thought to be associated with mortality risk in the COVID-19 population. Method(s): The IQVIA longitudinal medical and pharmacy claims databases identified 17,682,111 patients with a COVID-19 diagnosis between 4/1/2020-4/30/2022 from a population of >277 million patients in the US. Patients were linked to Veritas Data Research fact-of-death records (90% complete compared to CDC reporting) and confirmed deaths were flagged. Confirmed mortality rates (CMR) were evaluated by age group, socioeconomic status (SES) using the Area Deprivation Index (v2.0, University of Wisconsin, 2015), co-morbidities and COVID-specific (approved and unapproved) treatments. Result(s): Of the 563,744 patients (3.2%) identified as dead (3.67% in men, 2.85% in women overall), CMR was lowest in patients aged 0-17 (0.08%), highest in age 65-75 (5.92%) and >75 (16.40%). Patients in the lowest 40% of SES had CMR of 4.43% while in the highest 20% was 1.56%. Respiratory failure, pneumonia and sepsis were the most common acute diagnoses accompanying COVID-19 deaths in all SES. In patients with comorbid dementia or Alzheimer's disease, CMR were 21.62% and 23.40% respectively. Additionally, congestive heart failure (15.79%), atrial fibrillation (15.50%), chronic kidney disease (15.30%) and COPD (12.19%) were associated with high CMR. Among patients receiving approved therapies, casirivimab/imdevimab and remdesivir had CMR of 1.41% and 12.63% respectively, while for those receiving unapproved therapies, ivermectin and hydroxychloroquine had CMR of 2.54% and 2.45%. Conclusion(s): Compared to the 1.1% case-mortality rate (Johns Hopkins 2023) among US COVID-19 patients, we found CMR exceeded 3% among those with a medical claim for COVID-19. Advanced age, dementia, and cardio-renal disease were associated with mortality. Patients with the lowest SES had approximately 3 times the confirmed mortality rate compared to those in the highest SES group.Copyright © 2023

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.

Regional Variation in Patient Characteristics and Treatment Patterns for over 17 Million COVID-19 Patients in the United States

Objectives: According to the CDC, as of December 2022, almost one in three Americans had confirmed COVID-19 infection;yet only a small portion generated healthcare claims related to COVID-19. Higher burden of COVID-19 cases in Northeastern states compared to other US regions has been documented. This study examined the regional variation in demographic characteristics and treatment patterns among patients with a claim for COVID-19 in a nationwide US claims database. Method(s): Analysis of data from over 277 million patients in IQVIA's longitudinal medical and pharmacy claims databases resulted in a cohort of 17,682,111 patients with COVID-19 diagnosis between 4/1/2020 and 4/30/2022. Demographic characteristics and treatment rates for key approved and un-approved COVID-19 therapies were assessed and stratified by region. Result(s): Among patients in the database, 6.4% had a COVID-19 diagnosis. The proportion was higher in the Northeast (7.1%) and South (6.9%) compared with the West (4.8%). The highest proportion of patients were aged 18-44 years (32.7% in South to 35.2% in West). Over a fifth of the patients were >= 65 years old (US overall= 23.7%;22.5% in Northeast to 25.8% in Midwest). Approximately 57% of the patients nationally and within each region were women. For approved medications, utilization ranged from 1.7% in Northeast to 2.7% in Midwest (overall:2.2%) for remdesivir;0.7% in Northeast to 2.2% in South (overall: 1.5%) for casirivimab/imdevimab. For unapproved medications, utilization ranged from 0.9% in Northeast to 1.6% in South (overall:1.3%) for hydroxychloroquine and 0.4% in Northeast to 1.8% in South (overall:1.1%) for ivermectin. Conclusion(s): Less than one in five US cases of COVID-19 had a claim with diagnosis of COVID-19. Use of COVID-19 specific medications remained low throughout the pandemic. Despite the higher disease burden, proportion of patients with claims and receiving COVID-19 treatment were low nationally, particularly in the northeast US region.Copyright © 2023

Resolution Consensus Statement Neutralizing monoclonal antibodies for treatment of COVID-19 - a role in the treatment of vulnerable categories of patients.

In December 2022, the Council of Experts was held. It purpose was to determine the place of virus-neutralizing monoclonal antibodies (NMA) in the ethiotropic treatment of COVID-19 in vulnerable categories of patients. The main issues were identified and their solutions were proposed. At the first visit of pregnant women due to COVID-19, proactive identification of risk factors and early prescription of NMA are recommended, preferably - with published safety data in this category of patients (casirivimab + imdevimab). In patients with oncological and other chronic (rheumatology, pulmonology, gastroenterology) diseases, prophylactic use of NMA is recommended. regardless of the severity of the disease. For patients with chronic pathology regardless of the severity of the disease an early prescription of ethiotropic therapy must be provided, combating the long-term circulation of the virus. To solve the problem of late treatment prescription, it is necessary to: use rapid tests, prescribe NMA if indicated, even if the patient presents late, introduce digital technologies to transfer information about COVID-19 cases between healthcare institutions (HI), create call centers for primary triage of patients, daily hospitals to reduce the burden on the HI. The issue of NMA using related to changes in their activity against new variants of SARS-CoV-2 remains relevant. Among the proposed solutions are: priority of indications over information about the activity of NMA, the diversification of the choice of NMA in HI, taking into account clinical experience, indications for use and prognosis of NMA activity, the use of combined forms of NMA (for example, casirivimab + imdevimab) or a combination of NMA with other means of ethiotropic therapy.Copyright © 2023, Dynasty Publishing House. All rights reserved.

Real-world experience of monoclonal antibodies in mild-to-moderate COVID-19 patients at a tertiary care center.

Background: Neutralizing antibodies cocktail (casirivimab and imdevimab) has received emergency use authorization recommendation by Food and Drug Administration (FDA) and WHO for mild-to-moderate COVID-19 infection in specific high-risk groups. Antibodies cocktail has shown promising results in preventing progression to severe disease, but the real-world experience is still evolving. Herein, we present a retrospective analysis of 22 patients who were administered the antibodies cocktail between August 2021 and March 2022 at our tertiary care center. Methods: We conducted an observational retrospective analysis of clinicoradiological, inflammatory parameters, progression of the disease, and outcome among 22 mild and moderate COVID-19 patients treated with antibodies cocktail. Results: The mean age was 67.7 years (SD ± 18.3) and comprised of 13 males (59%), while 9 were females (40.9%). Nine (40.9%) patients were fully vaccinated with two doses, nine (40.9%) were partially vaccinated with one dose while four patients (18.2%) were unvaccinated, and the rest were unvaccinated. Diabetes and hypertension were the commonest comorbidities; hematological and solid organ malignancies were other comorbidities. Eight patients had radiological opacities consistent with COVID-19 pneumonia and had shown significant regression in four patients after the therapy. None of our patients required supplemental oxygen or progressed to severe acute respiratory distress syndrome. All patients were discharged in a stable condition within 6 days of the therapy. Conclusions: The neutralizing antibodies cocktail has shown encouraging results in our analysis in preventing progression to severe disease in patients with high-risk conditions.

Clinical study to compare the efficacy and safety of casirivimab & imdevimab, remdesivir, and favipravir in hospitalized COVID-19 patients.

Background: Corona Virus disease - 2019 (COVID-19) disease induces scientific research to find a control to this pandemic from 2020 year up to now. Recently, various advances in pharmacotherapy against COVID-19 have emerged. Objectives: To compare the efficacy and safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir, and Favipravir in the COVID-19 patients. Study design: This study is a single-blind non-Randomized Controlled Trial (non-RCT). The drugs of the study are prescribed by lectures on chest diseases, faculty of medicine-Mansoura University. The duration of the study is about six months after ethical approval.265 hospitalized COVID-19 patients were used to represent the COVID-19 population and were assigned into three groups in a ratio of (1:2:2) respectively, Group (A) received REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab)), group (B) received remdesivir, and group (C) received favipravir. Results: Casirivimab and imdevimab achieve less 28-day mortality rate, and less mortality at hospital discharge than Remdesivir, and Favipravir. Conclusion: From all of these results, it is concluded that Group A (Casirivimab & imdevimab) achieves more favorable outcomes than B (Remdesivir) & C (Favipravir) intervention groups. Clinical trial registration: NCT05502081, 16/08/2022, Clinicaltrials.gov.

Retrospective Analysis of Neutralizing Antibody Cocktail (Casirivimab and Imdevimab): A Game Changer in Treating Mild COVID-19 Patients

Our retrospective study aimed to evaluate the effectiveness of monoclonal antibodies (casirivimab and imdevimab) on mild cases of coronavirus disease 2019 patients admitted to the tertiary care center. A total of 161 patients were evaluated of which the test group consisted of 79 and the control group of 82. In the test group the patients had been administered with diluted 250 ml of 0.9 % sodium chloride along with co-formulated casirivimab (600 mg) and imdevimab (600 mg) solution intravenously and in the control group the patients were administered standard coronavirus disease 2019 treatment protocol. The monitoring of patients in both groups was done at least 1 h after drug infusion in the designated room. Post-treatment designed interviews were taken to evaluate the effectiveness of treatment. This retrospective analysis discovered a significant association of symptoms with the group at 48 h for injected and non-injected patients and 1 mo from the chi-square test after injecting monoclonal antibodies. There is no significant association of symptoms with the groups at 3 mo. A significant difference in the symptom distribution through different time points in the injected group and not injected group was observed. From the pairwise McNemar's test, a significant difference in the symptoms between each time in 48 h, the difference was p=0.0075 and after 1 mo, p<0.001 points in both groups. The combination of casirivimab and imdevimab could be considered a treatment of choice for vaccinated, non-vaccinated and mild to highrisk coronavirus disease 2019 patients.

Endogenous antibody response to SARS-CoV-2 in patients who received monoclonal antibodies against COVID-19: A systematic review

Passive immunization with mAbs has been employed in COVID-19. We performed a systematic review of the literature assessing the endogenous humoral immune response against SARS-CoV-2 in patients treated with mAbs. Administration of mAbs in seronegative patients led to a reduction in both antibody titres and neutralizing activity against the virus.Copyright © 2022

X-Linked Inhibitor of Apoptosis (XIAP) deficiency presenting as hemophagocytic lymphohistiocytosis triggered by drug allergy

X-linked inhibitor of apoptosis (XIAP) deficiency is a primary immunodeficiency associated with recurrent hemophagocytic lymphohistiocytosis (HLH) episodes. The clinical phenotypes of XIAP deficiency vary, ranging from splenomegaly to life-threatening inflammation. We report a case of XIAP deficiency with unusual late-onset HLH presentation likely triggered by a drug allergy. A previously healthy adolescent boy presented to the hospital with fever and rash seven days after starting antibiotics for a neck abscess. Laboratory evaluation demonstrated cytopenias, elevated liver enzymes, and increased inflammatory markers. Initially, antibiotics were discontinued due to concern for drug rash. He continued to deteriorate clinically and became hypotensive. Additional testing revealed decreased NK cell function, as well as elevated ferritin, triglycerides, and soluble IL-2 receptor. SLAM-Associated Protein (SAP) and XIAP evaluation by flow cytometry demonstrated decreased XIAP expression. Subsequently, genetic testing revealed a known pathogenic mutation in BIRC4 (c.421_422del), confirming the diagnosis of XIAP deficiency.Copyright © 2023

Moderate to Severe COVID-19 Illness in Pregnancy: The Experience in a Tertiary Centre in the United Kingdom

Background & Purpose: Pregnant women are at higher risk of developing severe COVID-19 compared with non-pregnant women, particularly in the third trimester1. Despite ongoing campaigns, the proportion of pregnant women vaccinated against SARS-CoV-2 is lower than in the general population2. The medium-term effects of COVID-19 during pregnancy are not well characterized. We report a cohort of pregnant women admitted to hospital with moderate-to-severe COVID-19. Method(s): Data from clinical records were retrospectively collected from all pregnant women admitted through the maternity assessment unit at St. Thomas' Hospital, between January 2021 and January 2022, due to COVID-19 requiring oxygen to maintain saturations >94%. Result(s): Fourteen women were identified (age=33.4+/-5.2 years;42.8% Caucasian;28.6% Black), requiring admission at 31+/-4.7 weeks gestation. Only two were double vaccinated (14.2%). Body mass index (BMI) was 27.2+/-6.4 kg/m2. Two women had concomitant co-morbidities (asthma and type 1 diabetes). They were managed in the obstetric high- dependency unit (level 1), barring one that required invasive ventilation for one day. The Delta variant was most commonly implicated (43%). All women requiring oxygen received steroids. Four women received Tocilizumab and three casirivimab/imdevimab;two received both. Four women were delivered by emergency Caesarean section due to maternal or fetal concerns, while the others continued their pregnancies. There was one late intrauterine death at 35 weeks. Women were followed-up for an average of six weeks. At follow-up in the obstetric medicine COVID-19 clinic, all women had complete resolution of COVID-19 on clinical examination, pulse oximetry and chest radiograph. Conclusion(s): In 14 pregnant women requiring admission to hospital for hypoxia secondary to moderate-to-severe COVID-19, concomitant co-morbidities and high BMI were not prevalent. Most were not vaccinated against SARS-CoV-2. Despite experiencing moderate-to-severe COVID-19, they had complete clinical and radiological resolution at six weeks follow-up.

Selected Abstracts from Pharmacology 2022

The proceedings contain 48 papers. The topics discussed include: statin use and risk of rheumatoid arthritis or osteoarthritis in type 2 diabetes mellitus: a propensity score-matched population-based study;oxidative stress index as predictive marker for disease progression and its correlation with proinflammatory cytokines and lymphocyte subsets in COVID-19;translating pharmacological developments into clinical practice: case study of Ronapreve for COVID-19;finding a cost-effective alternative from commonly used dipeptidyl peptidase-4 inhibitors in India: a systematic study;older adult psychiatry patient medication education SusQI 2021;how much data for prescribers of new medicines are derived from studies in healthy volunteers?;how much data for prescribers of new medicines are derived from studies in healthy volunteers?;and the interactive walkway provides sensitive biomarkers for drug effects on (adaptive) walking in healthy elderly volunteers.

French pharmacovigilance survey of casirivimab - imdevimab monoclonal antibodies in coronavirus disease (COVID-19).

INTRODUCTION: Casirivimab and imdevimab (Ronapreve®) are two recombinant human monoclonal antibodies (mAbs) that bind to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, preventing the virus from entering cells. In March 2021, this drug was granted emergency use authorisation (EUA) in France for early treatment of COVID-19 in patients at increased risk of progression to severe COVID-19. In August/September 2021, the indication was expanded to COVID-19 prevention (pre- or post-exposure prophylaxis) and treatment of hospitalised patients requiring non-invasive oxygen therapy. The aim of the study was to better describe the adverse drug reaction (ADR) profile and detect safety signals of this new drug used in COVID-19 treatment. METHODS: We described ADR profile with casirivimab/imdevimab reported as suspect/interacting drug to the French pharmacovigilance network and the pharmaceutical company between 17/03/2021 and 30/06/2022. Data presented correspond to the 2 periods of the pharmacovigilance survey: the first carried out by the pharmaceutical company for curative and prophylactic uses and the second by Toulouse university regional pharmacovigilance center (RPVC). RESULTS: A total of 384 reports were analysed and 256 were "serious". ADR profile was comparable between the 2 periods and between curative and prophylactic use, corresponding to expected ADRs such as infusion-related reactions and hypersensitivity, inefficiencies or worsened infections and deaths. Two potential pharmacovigilance signals were also studied: acute pulmonary oedemas and sudden deaths. DISCUSSION: No pharmacovigilance signal emerged from this 15 months French pharmacovigilance survey. Moreover data from published studies are also reassuring. This pharmacovigilance survey was the first one for the new version of EUA and with a new ADR reporting process i.e. declaration to the RPVC instead of the pharmaceutical company. Casirivimab/imdevimab is no longer used in France today but we continue to monitor this drug for any future evidence of resurgent activity on a new variant of Sars-CoV-2.

Real-world effect of casirivimab and imdevimab cocktail in patients infected with SARS-CoV-2 delta and omicron variants.

INTRODUCTION: The casirivimab and imdevimab antibody cocktail has proven to be extremely effective against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) delta variant. Currently, no data on the clinical outcomes of antibody cocktail with the newer omicron form is available. This retrospective study evaluated the effectiveness of casirivimab and imdevimab antibody cocktail in patients infected with SARS-CoV-2 delta and omicron variants. METHODOLOGY: Data of 85 patients of age < 60 years, with comorbid conditions and BMI > 25 kg/m2 were identified from a database of 871 patients. RESULTS: Most of the patients in both delta and omicron groups were administered 600 mg casirivimab + 600 mg imdevimab intravenously. SARS-CoV-2 symptoms started resolving from the 3rd day and by the end of the 14th day most patients in both groups did not report any symptoms. There was no significant difference between delta and omicron group with respect to average symptom onset days, number of hospitalized days post cocktail and number of days post cocktail administration to reverse transcription polymerase chain reaction (RT-PCR) negative status. Forty (58%) patients in the delta group and 16 (94%) patients in the omicron group had the high-resolution computed tomography (HRCT) score of zero. No patient required oxygen support during hospitalization and no mortality was reported. CONCLUSIONS: There was no difference in effectiveness and safety of casirivimab and imdevimab antibody cocktail in the patients infected with SARS-CoV-2 delta or omicron.

Monoclonal Antibody Use for Coronavirus Disease 2019 in Pediatric Patients: A Multicenter Retrospective Study.

Monoclonal antibodies for COVID-19 are authorized in high-risk patients aged ≥12 years, but evidence in pediatric patients is limited. In our cohort of 142 patients treated at seven pediatric hospitals between 12/1/20 and 7/31/21, 9% developed adverse events, 6% were admitted for COVID-19 within 30 days, and none received ventilatory support or died.

Clinical, virological, and operational aspects of a single-center Belgian experience with in-hospital infusions of casirivimab/imdevimab and sotrovimab for mild/moderate COVID-19.

OBJECTIVES: To describe the clinical and virological characteristics of COVID-19 patients treated in a hospital with casirivimab/imdevimab and sotrovimab between June 2021 and April 2022 and to report the logistics for administering these monoclonal antibodies (mAbs). METHODS: All COVID-19 adult patients treated with mAbs at CHU Charleroi (Belgium) were included. A multidisciplinary monoclonal antibodies team (MMT) was dedicated to identify eligible patients and coordinate the administration of mAbs in a temporary structure created within the hospital. RESULTS: A total of 69 COVID-19 patients were treated with casirivimab/imdevimab (11.6%) and sotrovimab (88.4%) within a median of 4 days of symptom onset, mainly during the Omicron B.1.1.529 period (71%); no severe adverse events occurred. Thirty-eight (55%) were outpatients, and among the 31 inpatients, 42% were nosocomial COVID-19. The median age was 65 years [IQR, 50-73], and 53.6% were male. The most common risk factors for progression to severe COVID-19 were immunosuppression (72.5%), arterial hypertension (60.9%) and age>65 years (47.8%). One fifth were SARS-CoV-2-unvaccinated patients. The median Belgian MASS score for patient prioritization was 6 [IQR, 4-8]. On Day 29, 10.5% of the outpatients were hospitalized, and 1.4% were admitted to an intensive care unit (ICU); there were no COVID-19-related deaths. General practitioners referred 19.4% of the outpatients. CONCLUSIONS: In our experience, mAbs were prescribed in very high-risk patients with no adverse events, few progressions to severe COVID-19, and no related deaths. Our MMT has improved coordination of COVID-19 treatment and contribute to enhance communication with primary care.

Comparison of Monoclonal Antibody Cocktail (Casirivimab-Imdevimab) Treatment with Remdesivir and Favipiravir in Mild to Moderate COVID-19 Infection: A Retrospective Study

Introduction: Favipiravir and remdesivir are antiviral drugs being used in the present pandemic and were also used previously for other viral infections in the past. Monoclonal antibody (Mab) Casirivimab-Imdevimab is a Coronavirus Disease 2019 neutralising antibody approved in the last one year. Therefore, a clinical comparison with the existing treatment modalities is imperative. Aim: To compare Mab with remdesivir and favipiravir for mild to moderate COVID-19 disease. Materials and Methods: A retrospective, observational and single-centre study was conducted at a COVID-19 infection facility and private tertiary care hospital, Mumbai, Maharashtra, India. Data of patients admitted during the period of 1st June 2021 to 31st August 2021 was collected and analysed in the months of September 2021 and October 2021. Adults participants diagnosed to have COVID-19 infection, not requiring critical care or oxygen therapy were included in the study. Time to recovery from treatment onset and the need for treatment escalation were the primary outcome measures. Data was entered into Microsoft Excel spreadsheet version 16 and analysed. Statistical analysis was carried out using Chi-square test for the significance of association between tabulated values of data for qualitative and categorical data. Two-tailed unpaired t-test and Analysis of Variance (ANOVA) was used for quantitative tabulated data. Results: This study included 158 participants, grouped into remdesivir(n=63),favipiravir(n=30)andMab(n=65)treatmentgroups. Gender distribution was comparable in all groups (p-value=0.08). The three groups were compared for need of treatment escalation and time of recovery. The Mab treatment group (on comparing with other treatment arms) had earlier symptom recovery when given to patients with mild COVID-19 disease (p-value=0.006 for major symptoms) or when treatment was started within five days of symptom onset (p-value <0.001). Patients in Mab treatment group with mild illness required no treatment escalation compared to other groups (p-value=0.011). However, time to recovery patients in all treatment groups was comparable in case of patients with moderate COVID-19 illness (p-value=0.7381). In patients with moderate COVID-19 illness Mab treatment group required more frequent treatment escalation compared to remdesivir treatment group (p-value=0.044), when treatment was started within 5 days of symptom onset remdesivir and mab were comparable for treatment escalation (p=0.144). Vaccination status of the three groups differed significantly (p-value=0.033) hence a further subanalysis was done. On further analysis, non-vaccinated patients receiving Mab recovered from minor symptoms (p-value=0.0006) earlier than those receiving Remdesivir. Amongst the participants of the Mab treatment-group, vaccinated and non-vaccinated patients had comparable recovery time and need for treatment escalation (p-value=0.57 and p-value=0.76, respectively). Participants who received Mab-treatment within five days of symptom onset;recovered earlier compared to those who received Mab treatment after five days (p-value=0.019). Conclusion: Monoclonal antibody treatment group compared to the other treatment groups had earlier recovery in non vaccinated patients, mild COVID-19 disease, and when treatment was started before or on the 5th day of symptom onset.

Comparison of clinical characteristics of COVID-19 in pregnant women between the Delta and Omicron variants of concern predominant periods

Background: Information regarding effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant strains on clinical manifestations and outcomes of coronavirus disease 2019 (COVID-19) in pregnant women is limited. Methods: A retrospective observational study was conducted using the data from the nationwide COVID-19 registry in Japan. We identified pregnant patients with symptomatic COVID-19 hospitalized during the study period. The Delta and Omicron variants of concern (VOC) predominant periods were defined as August 1 to December 31, 2021 and January 1 to May 31, 2022, respectively. Clinical characteristics were compared between the patients in the Delta and Omicron VOC periods. In addition, logistic regression analysis was performed to identify risk factors for developing moderate-to-severe COVID-19. Results: During the study period, 310 symptomatic COVID-19 cases of pregnant women were identified;111 and 199 patients were hospitalized during the Delta and Omicron VOC periods, respectively. Runny nose and sore throat were more common, and fatigue, dysgeusia, and olfactory dysfunction were less common manifestations observed in the Omicron VOC period. In the multivariable logistic regression analysis, onset during the later stage of pregnancy (OR: 2.08 [1.24–3.71]) and onset during the Delta VOC period (OR: 2.25 [1.08–4.90]) were independently associated with moderate-to-severe COVID-19, whereas two doses of SARS-CoV-2 vaccine were protective against developing moderate-to-severe COVID-19 (OR: 0.34 [0.13–0.84]). Conclusions: Clinical manifestations of COVID-19 in pregnant women differed between the Delta and Omicron VOC periods. SARS-CoV-2 vaccination was still effective in preventing severe COVID-19 throughout the Delta and Omicron VOC periods. © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases

Efficacy of Antibody Cocktail Drug in COVID-19 Positive Patients: A Retrospective Single-centered Study

Introduction: Neutralising monoclonal antibodies (mABs) have been proposed and developed for the treatment of Coronavirus Disease-2019 (COVID-19) patients with mild to moderate diseases and to prevent further progression. The combination of Casirivimab and Imdevimab blocks the entry of virus into cells by attaching to receptor binding domain of Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) spike glycoprotein. The mABs are utilised as a pre-emptive strategy in certain high-risk groups such as those suffering from chronic liver, kidney and respiratory disease, malignancies and other immunocompromised states where efficacy of vaccines may be suboptimal. Aim: To evaluate the clinical outcomes in COVID-19 patients who were treated with Antibody Cocktail drug (casirivimab and imdevimab). Materials and Methods: A retrospective observational study was conducted in patients confirmed positive for SARS-CoV-2 from June 2021 to January 2022 and subsequently, the collected data was analysed from May 2022 to June 2022. The study was conducted in a tertiary care referral hospital in eastern India. All eligible patient subsequently received casirivimab and imdevimab at COVID-19 facility. Monitoring of patients was done upto 12 hour postinfusion. Demographic parameters, routine investigations and clinical outcomes were assessed. Data entry was done using Microsoft Excel. Data was entered, coded and analysed using International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) version 21.0. All analysis was done at a preset alpha error of 5% and results expressed at confidence levels of 95%. Results: Total 104 eligible cases were taken in present study. Nearly, 93% of those patients who had not been vaccinated were at higher risk for having severely elevated levels of C-Reactive Protein (CRP) as compared to 48% of those with COVID-19 vaccination. Nearly, 9 out of 10 patients with moderate-severe CRP levels were at nine times more risk for longer duration of hospitalisation as compared to normal levels of CRP. All patients having moderate-severe CRP levels required mechanical ventilation in comparison to mild CRP levels. Patients with comorbidities were more likely to get severe COVID-19 infections (p-value ≤0.05). Unvaccinated subjects were more likely to have severe infections than vaccinated subjects. (p-value ≤0.05). Prolonged hospitalisation (>7 days) was statistically significant in severe COVID-19. Unvaccinated subjects had a statistically significant rise in CRP over vaccinated subjects. The majority of the patients receiving antibody cocktail did not require prolonged hospitalisation while a minor fraction required invasive ventilation. Antibody cocktail was safe, well tolerated and had good efficacy and low mortality rate as compared to other modalities of treatment in this study. Conclusion: The duration of hospitalisation and outcomes were superior in patients having mild to moderate COVID-19 who received antibody cocktail without any serious side-effects.