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1.
Journal of Medical Microbiology and Infectious Diseases ; 10(4):157-162, 2022.
Article in English | CAB Abstracts | ID: covidwho-20243545

ABSTRACT

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a significant health and financial issue in the current century. Despite significant attempts to manage the illness, the transmission routes of the virus and its widespread genomic mutations have led to an increasing number of new infections and mortality rates. In the absence of specific treatment for this new virus, identifying and managing factors affecting the prognosis of the disease is one of the critical strategies to reduce disease mortality. Patients with iron deficiency anemia (IDA), who account for an estimated half a billion people globally, are more prone to infections due to immune system disorders. Since they visit hospitals more frequently for follow-up care and diagnosis, they are more susceptible to becoming infected with SARS-CoV-2. Once infected with SARS-CoV-2, low hemoglobin (Hb) levels and compromised immune systems disrupt the restriction of infection in these individuals, ultimately leading to severe complications of COVID-19.

2.
Journal of Mycopathological Research ; 60(2):179-185, 2022.
Article in English | CAB Abstracts | ID: covidwho-20241729

ABSTRACT

In recent times, numerous reports of systemic fungal infections have been a major concern. The angioinvasive fungal infection, mucormycosis has surged in patients with COVID-19 due to various factors, mainly uncontrolled diabetes and inappropriate corticosteroid use. The prevalence of this acute and fatal fungal infection caused by Mucorales-related fungal species has been highest in the Indian population. COVID-associated mucormycosis (CAM) has a propensity for contiguous spread, and exhibits high morbidity as well as mortality. Unless promptly detected and treated, it is associated with a poor prognosis. A high index of suspicion, aggressive surgical debridement and use of systemic antifungal agents continue to be the standard of care for CAM. Moreover, there is an imperative need to address this public health issue by increasing public awareness and education. This article provides a comprehensive overview on the emergence of CAM during the pandemic, the current burden, pathophysiology, diagnostic interventions and management of CAM in Indian clinical practice.

3.
Annals of the Rheumatic Diseases ; 82(Suppl 1):2036-2037, 2023.
Article in English | ProQuest Central | ID: covidwho-20234508

ABSTRACT

BackgroundVaccination against SARS-CoV2 had a critical role in the fight against COVID19 pandemic.A weaker humoral response to COVID19 vaccine has been found in rheumatic patients treated with Rituximab (RTX) or Mycophenolate Mofetil (MMF)[1]. Despite the evidence that anti-SARS-CoV-2 mRNA vaccines can elicit a T-cell response [2], some data show that even the cellular immunity could be impaired in rheumatic patients [3] but COVID19 serology is the only parameter that is feasible to measure in daily practice.Tixagevimab+cilgavimab are two human-derived monoclonal antibodies administered parenterally and authorized by regulatory agencies in February 2022 for pre-exposure prophylaxis (PrEP) against COVID19 from different virus variants in fragile patients.ObjectivesTo demonstrate safety and effectiveness of tixagevimab+cilgavimab.MethodsPatients with autoimmune rheumatic diseases undergoing immunosuppressive treatment with RTX or MMF during the vaccination campaign were enrolled between April and June 2022. All patients must have anti-spike antibody levels below the protective threshold (defined by anti-spike IgG titre <250 BAU/ml) after receiving at least 2 vaccine doses.Patients were monitored with a questionnaire every month about COVID19 symptoms (including respiratory and gastrointestinal symptoms, anosmia and ageusia, skin rash and potential contact with COVID19+ subjects) and were checked for anti-spike and anti-nucleocapside antibodies titres every 2 months for a total of a 6 month follow-up. MMF dose was reduced at 1 g/die at the time of vaccine administration.ResultsFifteen patients were enrolled: 9 participants had a connective tissue disease (CTD;1 dermatomyositis, 3 anti-syntethase syndrome, 4 systemic sclerosis, 1 systemic lupus erythematosus) and 6 had vasculitis (all granulomatosis with polyangiitis). 12 of them received RTX in the preceding 12 months and 3 were taking MMF.About safety, the therapy was very well tolerated and only 4 patients (26%) reported a non-severe adverse event in the 2 weeks following drug administration (2 myalgia, 1 headache, 1 fatigue), none of them requiring hospitalization nor pharmacologic treatment.Regarding effectiveness, 3/15 patients contracted SARS-Cov2 infection (20%) with mild symptoms and no need for hospitalization nor oxygen therapy. Only 1 of them received an antiviral drug (nirmatrelvir+ritonavir). All infected patients had a CTD diagnosis. No significant correlation was observed between the type of rheumatic disease and the risk of infection or response to tixagevimab+cilgavimab.ConclusionNone of our patients developed severe adverse events after tixagevimab+cilgavimab administration and, among the 3 SARS-CoV2 infected patients, none required hospitalization nor oxygen therapy.We conclude that in our experience tixagevimab+cilgavimab is a safe and useful complementary immunization strategy to vaccination for COVID19 prophylaxis.These data will be implemented in a larger study, comprehending various immunocompromised patients from several departments.References[1] Furer et al., Ann Rheum Dis, 2021[2] Mangalakumari et al., Nat Rev Immunol, 2020[3] Picchianti-Diamanti et al., Front Immunol, 2021Charateristic of the cohortIdentificativeAgeDiagnosisRTX/MMFSARS-CoV2 InfectionHospitalizationAntiviral drugs180SScMMF-//270ASSDRTX+nono370ASSDRTX+noyes452GPARTX-//551GPARTX-//649SSc+SSjRTX-//768SScMMF-//847LESRTX-//964ASSDRTX-//1068GPARTX-//1123GPARTX-//1258DMRTX+nono1361SScMMF-//1475GPARTX-//1569GPARTX-//Figure 1.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

4.
Cureus ; 15(4): e38049, 2023 Apr.
Article in English | MEDLINE | ID: covidwho-20241679

ABSTRACT

Probiotics are microorganisms, typically bacteria, similar to beneficial microbiota found in the human gut, usually consumed as dietary supplements or fermented foods. Although probiotics are generally safe, several cases of bacteremia, sepsis, and endocarditis associated with probiotics have been reported. Here we report a rare case of Lactobacillus casei endocarditis in a 71-year-old female, immunocompromised due to chronic steroid intake, who presented with a productive cough and low-grade fever. Blood cultures grew L. casei resistant to vancomycin and meropenem. Transesophageal echocardiography showed mitral and aortic vegetations; valve replacement was done after successfully removing vegetations. She was treated with a six-week course of daptomycin and recovered.

5.
Cureus ; 15(4): e38024, 2023 Apr.
Article in English | MEDLINE | ID: covidwho-20238678

ABSTRACT

Objectives Immunocompromised patients, specifically those with solid organ transplants or cancer on chemotherapy, are at particularly high risk of severe pneumonia and opportunistic infections. In select patients, bronchoalveolar lavage (BAL) is performed to provide high-quality samples for analysis. We compare BioFire® FilmArray® Pneumonia Panel (BioFire Diagnostics, Salt Lake City, Utah, United States), a multiplex polymerase chain reaction (PCR) assay, with standard of care diagnostics in BAL samples from immunocompromised patients to identify opportunities for this test to affect clinical decision making. Methods Patients hospitalized with pneumonia based on clinical and radiographic findings who underwent evaluation with bronchoscopy between May 2019 to January 2020 were reviewed. Among those patients undergoing bronchoscopy, those who were immunocompromised were selected for inclusion in the study. BAL specimens submitted to the microbiology laboratory were chosen based on as part of the internal validation of the panel in comparison with sputum culture at our hospitals. We compared the outcomes of the multiplex PCR assay with traditional culture methods and evaluated the role of PCR assay in de-escalating antimicrobial therapy. Results Twenty-four patients were identified for testing with the multiplex PCR assay. Of the 24 patients, 16 were immunocompromised, all with solid or hematological malignancy or a history of organ transplant. Seventeen individual BAL samples from the 16 patients were reviewed. BAL culture results and the multiplex PCR assay were in agreement in 13 samples (76.5%). In four cases, the multiplex PCR assay identified a possible causative pathogen not detected by standard workup. The median time to de-escalation of antimicrobials was three days (interquartile range (IQR) 2-4) from the day of collection of the BAL samples. Conclusions Studies have established the additive role of multiplex PCR testing in addition to traditional diagnostic tools like sputum culture in diagnosing the etiology of pneumonia. Limited data exist specifically looking at immunocompromised patients, in whom a timely and accurate diagnosis is particularly important. There is a potential benefit for performing multiplex PCR assays as an additive diagnostic tool in BAL samples for these patients.

6.
Viruses ; 15(5)2023 05 19.
Article in English | MEDLINE | ID: covidwho-20233031

ABSTRACT

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.


Subject(s)
COVID-19 , Aged , Male , Humans , Aged, 80 and over , Female , Retrospective Studies , COVID-19 Drug Treatment , Antibodies, Monoclonal/therapeutic use , Antibodies, Neutralizing , Immunocompromised Host , Disease Progression
7.
Romanian Archives of Microbiology and Immunology ; 81(1):53-55, 2022.
Article in English | CAB Abstracts | ID: covidwho-2324736

ABSTRACT

A 64-year-old never-smoker man, with professional exposure, presented to Marius Nasta Pneumophtisiology Institute for fatigability to effort, in the context of severe SARS-COV2 infection one month previously. His medical history includes pulmonary tuberculosis (55 years ago) and newly diagnosed type II diabetes (261 mg/dL glycemia). The thoracic tomography computer in the immediate post-COVID period (Fig. 1A) revealed the presence of glass ground lesions and a 3 cm nodule with cystic degeneration in the upper left lobe. A gross examination of the specimen identified a condensation area of 2.5 cm diameter, brown-grey colored, with necrosis and central ulceration. Microscopic examination showed the presence of bronchiectasis with squamous metaplasia of the epithelium, which appears ulcerated;numerous calcium oxalate crystals with adjacent foreign body granulomatous reaction;endobronchial are present fibrinous and inflammatory debris, brown-black pigment, and septate, dichotomous branching hyphae, suggestive of Aspergillus spp. A periodic acid-Schiff stain was performed, identifying the fungal hyphae. The histopathological diagnosis was bronchiectasis supra-infected and colonized with fungal filaments (Aspergillus niger).

8.
Journal of Siberian Medical Sciences ; 4:145-160, 2022.
Article in English, Russian | CAB Abstracts | ID: covidwho-2315907

ABSTRACT

The article is devoted to the global problems of modern medicine - HIV infection and the COVID-19 pandemic. The review of the literature highlights current ideas about the pathogenesis and course of COVID-19 in patients with HIV infection, and also touches upon the problems of concomitant pathology and mental health of patients with HIV in the setting of the COVID-19 pandemic. It has been shown that HIV-positive patients are a risk group for the severe course of COVID-19, in particular, individuals with severe immunodeficiency (CD4+ T lymphocytes 200 cells/l) due to the development of synergetic lung damage by SARS-CoV-2 and secondary infectious agents such as cytomegalovirus and Pneumocystis carinii. It has been proven that one of the targets of the SARS-CoV-2 virus is CD4+ T cells, which in COVID-19 leads to a more rapid progression of immunodeficiency in patients with HIV infection and, thus, significantly increases the risk of secondary diseases and death. Particular attention should be paid to middle-aged and elderly people living with HIV, who, compared with HIV-negative patients, are more likely to have concomitant pathology - arterial hypertension, cardiomyopathy and diabetes mellitus, which are the risk factors for severe COVID-19. The results of studies on the effect of antiretroviral drugs on the course of COVID-19 showed that HIV-infected patients receiving tenofovir + emtricitabine have a lower risk of severe COVID-19 and associated hospitalization than patients receiving other HIV treatment regimens. Clinical and preclinical data support the potential use of tenofovir in the treatment of novel coronavirus infection.

9.
Chinese Journal of Viral Diseases ; 12(5):390-395, 2022.
Article in Chinese | GIM | ID: covidwho-2296662

ABSTRACT

Herpes zoster is a cluster blister disease that often occurs on the skin of the elderly, immunocompromised individuals and patients with chronic diseases, which is caused by the reactivation of varicella zoster virus dormant in neurons. The persistent pain of herpes zoster tortures patients and is responsible for serious mental and economic burden. With no effective drug treatment for patients, vaccination becomes more important in disease prevention. Now live attenuated vaccine and recombinant protein vaccine with adjuvant are clinically available abroad. Based on the clinical data, recombinant protein vaccine with adjuvant is the preferred one recommended by CDC.In China, many enterprises perform clinical studies on the two vaccines. However, due to the limitation of adjuvant supply, recombinant protein vaccines have not been widely provided. With the global pandemic of COVID-19, mRNA vaccine becomes a hotspot worldwide. Domestic biological enterprises should actively develop new herpes zoster vaccine to fill the vaccine vacancies in China and to enhance market competitiveness. This article briefly reviews the research progress and development of herpes zoster vaccine in various vaccine platforms.

10.
Indian Journal of Medical Sciences ; 74(2):79-85, 2022.
Article in English | CAB Abstracts | ID: covidwho-2273658

ABSTRACT

Objectives: COVID-19 pandemic has shown a substantial impact on the entire world both physiologically and psychologically. By the hit of the second wave, which opened dangerous gates for secondary infections, apprehension was carried among health-care sectors. These secondary infections were due to decreased immunity. On the other hand, risk modifiers, such as diabetes and hypertension played a leading role in the mortality rate. A substantial number of studies have not been conducted so far regarding the impact of this second wave on dental healthcare professionals. The present study aimed to evaluate the dental healthcare professionals' perspective levels during the second wave of the COVID-19 pandemic through a web-based survey. Material and Methods: A total of 853 responses were gathered by sending 15 questions in Google forms. Data collected were gathered and subjected to statistical analysis, expressed in frequency distribution and Pearson's Chi-square test was performed. Results: Data obtained and projected that the study population expressed higher anxiety and stress levels, despite which was many of them showed an inclination to work during these tough times. The knowledge about secondary fungal infections like Mucormycosis, which was caused due to immune suppression, was abundant among the participants. A significant proportion conveyed the ill effect of COVID-19 on clinical practice and academics as well. Conclusion: Dental professionals have shown a positive perspective despite of higher stress levels and being a part of frontline workers, they are much primed to assure, educate, and treat the patients amidst the COVID-19 pandemic.

11.
Journal of Pure and Applied Microbiology ; 16(3):1441-1446, 2022.
Article in English | CAB Abstracts | ID: covidwho-2259962

ABSTRACT

Mucormycosis is a rare type of fungal infection commonly known as zygomycosis, the infection tends to crop up more commonly in individuals with low and weakened immunity level, if left untreated, the mucormycosis can be life-threatening and fatal. Mucormycosis previously known as zygomycosis is a consequential type of infection caused by several mildews known as micromycetes. The revised taxonomical studies revealed that the micromycetes causing the infections are classified as the species of phylum Glomeromycota, class Glomeromycetes, subphylum Mucoromycotina, order Mucorales. The genera of Rhizopus, Mucor, Lichtheimia, Cunninghamella, Rhizomucor, and Apophysomyces, constitute the causative agents of the majority of cases of mucormycosis. The angioinvasive type of disorder caused by mucormycosis is further classified as Mucorales. The patients with Diabetes ketoacidosis and diabetes mellitus are at high-risk factors, followed by the patients with organ transplant, immunocompromised disease, and malignancy. The route of exposure to Mucormycosis may be through the wounded infection that can be pneumonic, or dermal in origin. In the ectodermal form, the fungal organism can invade the skin through open or puncture wounds, or the laceration on the skin. However, the infection has a high mortality rate, the key to successful treatment is early diagnosis, and administration of antifungal drugs, with extensive therapy, followed by surgical debridement of the infection. The morbidity and mortality rate are still at a high number, due to the negligence of the patient to seek medical treatment. Hence the early diagnosis and treatment with antifungal drugs with surgical debridement is a must. The efficacy of oral and venous formulations in the treatment of mucorales is still under debate. Despite the aggressive therapy, the mortality rate is increasing worldwide. The studies have to be conducted to invent the fastest treatment protocol for the treatment of Mucormycosis.

12.
Infectious Diseases Now ; 52(8 Suppl):S1-S22, 2022.
Article in English | GIM | ID: covidwho-2247141

ABSTRACT

This special issue includes 10 articles that discuss SARS-CoV-2 genetic diversity;heterologous prime boost COVID 19 vaccination;pros and cons of vaccinating children;progress in treatment of immunocompromised COVID-19 patients;pharmacovigilance for COVID-19 vaccines;attitudes of French adults toward COVID-19 vaccination;attitudes of healthcare professionals toward the COVID-19 vaccination campaign in France.

13.
Infect Chemother ; 2022 Nov 18.
Article in English | MEDLINE | ID: covidwho-2266385

ABSTRACT

BACKGROUND: Determination of the release from isolation for coronavirus disease 2019 (COVID-19) in immunocompromised patients who need additional hospitalization for treatment of non-COVID-19 related disease is important to prevent nosocomial transmission. However, there is insufficient evidence for an extended isolation period. MATERIALS AND METHODS: In September 2021, when the Delta variant was dominant, a nosocomial outbreak of COVID-19 occurred in the nephrology ward of a tertiary hospital in Gwangju, Korea. We conducted epidemiological investigations and whole-genome sequencing (WGS) of this virus. RESULTS: A man who underwent kidney transplantation was admitted to our hospital for the treatment of acute kidney injury. He was diagnosed with asymptomatic COVID-19 infection during a pre-admission screening test on September 1, 2021 and underwent isolation. After 10 days of isolation in the COVID-19-designated ward, he was transferred to the general nephrology ward. He underwent steroid pulse therapy (September 17 to September 23, >60 mg/day prednisolone) due to acute T-cell rejection. On September 28, 2021, the first patient with COVID-19 was identified in the nephrology ward, and a rapid-response team was activated to identify additional patients with COVID-19 and prevent the spread of COVID-19. Epidemiological investigations revealed that 12 patients, two caregivers, and three healthcare workers from the nephrology ward were diagnosed with COVID-19. The WGS of specimens from 14 nosocomial outbreak samples and released an index patient exhibited the same Delta variant originating from the B.1.617.2 lineage. This hospital-acquired COVID-19 outbreak in the nephrology ward resulted in two (11.7%) deaths in patients who underwent kidney transplantation. CONCLUSION: We demonstrated that an immunocompromised patient can cause a nosocomial outbreak due to the prolonged shedding of infectious viruses. Prolonged isolation in patients under active immunosuppressive therapy may be necessary to prevent transmission, especially in the hospital setting.

14.
Clin Infect Dis ; 2022 Aug 12.
Article in English | MEDLINE | ID: covidwho-2231656

ABSTRACT

Antibody responses to SARS-CoV-2 vaccination are reduced in solid organ transplant recipients (SOTRs). We report that increased levels of pre-existing antibodies to seasonal coronaviruses are associated with decreased antibody response to SARS-CoV-2 vaccination in SOTRs, supporting that antigenic imprinting modulates vaccine responses in this immunosuppressed population.

15.
J Clin Virol ; 160: 105382, 2023 03.
Article in English | MEDLINE | ID: covidwho-2210736

ABSTRACT

BACKGROUND: Tixagevimab-cilgavimab is used for pre-exposure prophylaxis of COVID-19 in immunocompromised patients, though in vitro data has shown reduced neutralizing activity against SARS-CoV-2 Omicron subvariants. METHODS: We performed genomic sequencing of SARS-CoV-2 isolated from patients diagnosed with COVID-19 following tixagevimab-cilgavimab. Resistance-associated substitutions were used to generate a predicted phenotypic susceptibility analysis to tixagevimab-cilgavimab and bebtelovimab. Clinical data collected from these patients included SARS-CoV-2 immunization status, COVID-19-directed therapies, and outcomes. RESULTS: SARS-CoV-2 genome sequencing was performed in 25 patients. SARS-CoV-2 Omicron BA.2 was the most common identified subvariant. All patients had viral isolates with spike codon substitutions associated with reduced susceptibility to tixagevimab-cilgavimab; their predicted phenotypic analysis showed a >2-fold reduced susceptibility to tixagevimab-cilgavimab. Two patients had viral isolates with spike codon substitutions (K444N and G446D) associated with highly reduced susceptibility to bebtelovimab, although all the viral isolates had <2-fold reduced susceptibility based on predicted phenotypic analysis. Sixteen patients received rescue therapy with bebtelovimab, but one patient with BA.2 subvariant harboring K444N mutation died of COVID-19-related complications. Five patients received other COVID-19 therapies and survived. Four had mild or asymptomatic COVID-19 with an uncomplicated course despite not receiving any additional therapy. DISCUSSION: Multiple SARS-CoV-2 Omicron spike codon substitutions that correlated with reduced susceptibility to tixagevimab-cilgavimab were identified in patients with COVID-19 after receiving this monoclonal antibody. Most patients had an uncomplicated course. The identification of spike codon substitutions conferring resistance to bebtelovimab highlights the importance of performing genomic surveillance to identify new resistant SARS-CoV-2 variants.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , Antibodies, Monoclonal , Immunocompromised Host , Antibodies, Neutralizing , Antibodies, Viral
16.
J Clin Med ; 12(3)2023 Jan 21.
Article in English | MEDLINE | ID: covidwho-2200432

ABSTRACT

OBJECTIVE: We aim to describe the safety and efficacy of sotrovimab in severe cases of COVID-19 in immunocompromised hosts. METHODS: We used a retrospective multicenter cohort including immunocompromised hospitalized patients with severe COVID-19 treated with sotrovimab between October 2021 and December 2021. RESULTS: We included 32 patients. The main immunocompromising conditions were solid organ transplantation (46.9%) and hematological malignancy (37.5%). Seven patients (21.9%) had respiratory progression: 12.5% died and 9.4% required mechanical ventilation. Patients treated within the first 14 days of their symptoms had a lower progression rate: 12.0% vs. 57.1%, p = 0.029. No adverse event was attributed to sotrovimab. CONCLUSIONS: Sotrovimab was safe and may be effective in its use for immunocompromised patients with severe COVID-19. More studies are needed to confirm these preliminary data.

17.
Infectious Disease Clinics of North America ; 36(2):231-494, 2022.
Article in English | GIM | ID: covidwho-2124387

ABSTRACT

This special issue that contains 11 articles provides a thorough primer on virology, pathogenesis, transmission, clinical manifestations, treatments, and vaccines, with important information pertaining to specific risk populations, such as pregnant persons, children, individuals with different types of immune compromise, and the risks disproportionately born by those with societally marginalized identities.

18.
Drug Safety ; 45(10):1235, 2022.
Article in English | ProQuest Central | ID: covidwho-2044997

ABSTRACT

Introduction: After many months from the COVID-19 pandemic beginning, several anti-spike monoclonal antibodies (mAbs) and, more recently, other antiviral drugs for COVID-19 treatment in non-hospitalized patients have been marketed. Specifically, those drugs are indicated for SARS-CoV-2 infection early treatment in outpatient adults at high risk of developing severe COVID-19 [1]. Objective: To evaluate the post-marketing safety profile of antivirals drugs used for early COVID-19 treatment, using the World Health Organization global spontaneous reporting database (VigiBase). Methods: From VigiBase we identified all the individual case safety reports (ICSRs) of marketed mAbs (regdanvimab, sotrovimab, casirivimab/imdevimab, bamlanivimab/etesevimab and, specifically for COVID-19 prevention in immunocompromised patients, tixagevimab/cilgavimab) and other antiviral therapies for COVID-19 early treatment (remdesivir, nirmatrelvir/ritonavir, molnupiravir). We performed a descriptive analysis of ICSRs recorded in VigiBase of patients' demographics (age, sex, continent of origin) type of reporter, adverse drug reactions (ADRs) (Preferred Term level) and the Important Medical Events (IMEs), from their marketing date to May 4, 2022. In addition, we conducted a disproportional analysis using Reporting Odds Ratio (ROR), along with 95% confidence intervals (CIs), by comparing the frequency of ADRs (System Organ Class level) for each drug of interest with distribution of all ADRs from the whole database, excluding vaccines, reported in the same period. Results: Overall, up to 4th May,2022, 15,437 ICSRs of anti-spike mAbs (casirivimab/imdevimab: 27.2%;bamlanivimab/etesevimab: 7.3%;sotrovimab 3.3%;tixagevimab/cilgavimab 2.7% regdanvimab: 0.2%) and other antivirals (remdesivir: 54.5%;nirmatrelvir/ritonavir: 4.3%;molnupiravir 0.5%) from VigiBase were retrieved. ICSRs mainly involved females and 45-64 years old. The percentage of ICSRs that included IMEs was 32.4%. Overall, the most frequently reported ADRs were infusion-related reaction for both casirivimab/imdevimab (20.1%) and bamlanivimab/etesevimab (19.3%), pyrexia for regdanvimab (30.0%) and sotrovimab (8.1%), increased alanine aminotransferase for remdesivir (13.3%), dysgeusia for nirmatrelvir/ritonavir (39.5%), and diarrhoea for molnupiravir (18.8%). Overall, statistically significant RORs were observed for "Investigations" with remdesivir (N = 3163;ROR: 5.56;95% CI 5.32-5.81), "Gastrointestinal disorders" for molnupiravir (N = 178;ROR: 3.43;95% CI 2.82-4.17) and "Vascular disorders" for sotrovimab (N = 51;ROR: 2.07;95% CI 1.55-2.76). Conclusion: This study shows that the safety profile of anti-spike mAbs and other newly marketed antiviral therapies for the early treatment of COVID-19 is overall favourable. The most frequently reported ADRs in VigiBase are in line with those reported in the pivotal trials and Summary of Product Characteristics for all investigated antiviral drugs. The disproportional analysis identified some potential signals requiring further investigation.

19.
Annals of Oncology ; 33(Suppl. 3):S230-S230, 2022.
Article in English | GIM | ID: covidwho-2035757

ABSTRACT

Background: Cancer patients are more sensitive to infection induced by SARS-CoV-2, especially ones with impaired immune response. Vaccines are approved as safe and effective, and they are recommended in oncology patients. The aim of our study was to see the percentage of reinfections after second dose of vaccines against SARS-CoV2.

20.
Annals of Oncology ; 33(Suppl. 3):S225-S225, 2022.
Article in English | GIM | ID: covidwho-2035756

ABSTRACT

Background: The COVID-19 pandemic has led to more than 260 million infections and 55 million deaths as of early December 2021, worldwide. Vaccinating people against COVID-19 is considered as he best approach to overcome the pandemic since COVID 19-vaccines are effective and can reduce the risk of getting and spreading the virus. However, their efficacy and safety in patients with underlying disease such as cancers have not been approved yet. Here we report a cohort study on immunogenicity and safety of the inactivated SARS-CoV-2 vaccine (BBIBP-CorV) in patients with breast cancer, who were vaccinated as a part of a national plan for vaccination of patients with special diseases.

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