ABSTRACT
The objective of this study was to investigate the impact of the COVID-19 pandemic on the outcome of patients on the liver transplantation (LT) waitlist in 2020 in France, in particular, the incidence of deaths and delisting for worsening condition, depending on the allocation score component. The 2020 cohort of patients on the waiting list was compared with the 2018/2019 cohorts. 2020 saw fewer LTs than in either 2019 or 2018 (1128, 1356, and 1325, respectively), together with fewer actual brain dead donors (1355, 1729, and 1743). In 2020, deaths or delisting for worsening condition increased significantly versus 2018/2019 (subdistribution hazard ratio 1.4, 95% confidence interval [CI] 1.2-1.7), after adjustment for age, place of care, diabetes, blood type, and score component, although COVID-19-related mortality was low. This increased risk mainly concerned patients with hepatocellular carcinoma (1.52, 95% CI 1.22-1.90), with 650 MELD exception points (2.19, 95% CI 1.08-4.43), and especially those without HCC and MELD scores from 25 to 30 (3.36 [95% CI 1.82-6.18]). In conclusion, by significantly decreasing LT activity in 2020, the COVID-19 pandemic increased the number of waitlist deaths and delisting for worsening condition, and significantly more for particular components of the score, including intermediate severity cirrhosis.
Subject(s)
COVID-19 , Carcinoma, Hepatocellular , End Stage Liver Disease , Liver Neoplasms , Liver Transplantation , Humans , Carcinoma, Hepatocellular/epidemiology , Carcinoma, Hepatocellular/surgery , Carcinoma, Hepatocellular/etiology , Liver Transplantation/adverse effects , Liver Neoplasms/epidemiology , Liver Neoplasms/surgery , Liver Neoplasms/etiology , Pandemics , COVID-19/epidemiology , COVID-19/etiology , Severity of Illness IndexABSTRACT
Background: Early-phase neoadjuvant trials have demonstrated promising results in the utility of upfront immunotherapy in locally advanced stage III melanoma and unresected nodal disease. Secondary to these results and the COVID-19 pandemic, this patient population, traditionally managed through surgical resection and adjuvant immunotherapy, received a novel treatment strategy of neoadjuvant therapy (NAT). Methods: Patients with node-positive disease, who faced surgical delays secondary to COVID-19, were treated with NAT, followed by surgery. Demographic, tumour, treatment and response data were collected through a retrospective chart review. Biopsy specimens were analysed prior to the initiation of NAT, and therapy response was analysed following surgical resection. NAT tolerability was recorded. Results: Six patients were included in this case series; four were treated with nivolumab alone, one with ipilimumab and nivolumab and one with dabrafenib and trametinib. Twenty-two incidents of adverse events were reported, with the majority (90.9%) being classified as grade one or two. All patients underwent surgical resection: three out of six patients following two NAT cycles, two following three cycles and one following six cycles. Surgically resected samples were histopathologically evaluated for the presence of disease. Five out of six patients (83%) had ≤1 positive lymph node. One patient showed extracapsular extension. Four patients demonstrated complete pathological response; two had persisting viable tumour cells. Conclusions: In this case series, we outlined how in response to surgical delays secondary to the COVID-19 pandemic, NAT was successfully applied to achieve promising treatment response in patients with locally advanced stage III melanoma.
Subject(s)
COVID-19 , Melanoma , Humans , Nivolumab/therapeutic use , Neoadjuvant Therapy/methods , Retrospective Studies , Pandemics , Antineoplastic Combined Chemotherapy Protocols , Neoplasm Staging , COVID-19/etiology , Melanoma/drug therapyABSTRACT
The usage of electric scooters has been popular because it is a cheap and fast transportation method. Its use has increased in recent years because public transportation is less preferred during the covid-19 pandemic and in parallel, the publications reporting e-scooter accidents are increasing. There is no article examining the relationship between e-scooter and anterior cruciate ligament (ACL) injury in current literature. We aim to examine the relationship between e-scooter accidents and ACL injury incidence. Patients over the age of 18 years who applied to our orthopedics outpatient clinic with the diagnosis of ACL injury between January 2019- June 2021 were evaluated. 80 e-scooter accidents resulting with ACL tears were reviewed. The electronic medical records of the patients were reviewed retrospectively. Information about the age, gender, trauma history of the patients, and type of trauma was obtained. Fifty-eight patients had a history of falling while stopping the scooter, and 22 patients had a history of falling after hitting something. Anterior cruciate ligament reconstruction was performed with hamstring tendon grafts in 62(77,5%) of the patients included in the study. 18 (22,5%) patients were followed up with functional physical therapy exercises because they did not want to be operated on. Various bone or soft tissue injuries while using e-scooters have been reported in the literature until now. ACL injury is also seen quite frequently after these traumas, and necessary information and warnings should be given to the users to prevent ACL injuries.
Subject(s)
Anterior Cruciate Ligament Injuries , Anterior Cruciate Ligament Reconstruction , COVID-19 , Humans , Adult , Middle Aged , Anterior Cruciate Ligament Injuries/etiology , Anterior Cruciate Ligament Injuries/surgery , Retrospective Studies , Pandemics , COVID-19/etiology , Anterior Cruciate Ligament Reconstruction/adverse effects , Anterior Cruciate Ligament Reconstruction/methodsABSTRACT
BACKGROUND: Among patients with resected, epidermal growth factor receptor (EGFR)-mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), adjuvant osimertinib therapy, with or without previous adjuvant chemotherapy, resulted in significantly longer disease-free survival than placebo in the ADAURA trial. We report the results of the planned final analysis of overall survival. METHODS: In this phase 3, double-blind trial, we randomly assigned eligible patients in a 1:1 ratio to receive osimertinib (80 mg once daily) or placebo until disease recurrence was observed, the trial regimen was completed (3 years), or a discontinuation criterion was met. The primary end point was investigator-assessed disease-free survival among patients with stage II to IIIA disease. Secondary end points included disease-free survival among patients with stage IB to IIIA disease, overall survival, and safety. RESULTS: Of 682 patients who underwent randomization, 339 received osimertinib and 343 received placebo. Among patients with stage II to IIIA disease, the 5-year overall survival was 85% in the osimertinib group and 73% in the placebo group (overall hazard ratio for death, 0.49; 95.03% confidence interval [CI], 0.33 to 0.73; P<0.001). In the overall population (patients with stage IB to IIIA disease), the 5-year overall survival was 88% in the osimertinib group and 78% in the placebo group (overall hazard ratio for death, 0.49; 95.03% CI, 0.34 to 0.70; P<0.001). One new serious adverse event, pneumonia related to coronavirus disease 2019, was reported after the previously published data-cutoff date (the event was not considered by the investigator to be related to the trial regimen, and the patient fully recovered). Adjuvant osimertinib had a safety profile consistent with that in the primary analysis. CONCLUSIONS: Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected, EGFR-mutated, stage IB to IIIA NSCLC. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.).
Subject(s)
COVID-19 , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Humans , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/genetics , Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/surgery , COVID-19/etiology , ErbB Receptors/genetics , Lung Neoplasms/drug therapy , Lung Neoplasms/genetics , Lung Neoplasms/mortality , Lung Neoplasms/surgery , Mutation , Neoplasm Recurrence, Local/drug therapy , Survival AnalysisABSTRACT
BACKGROUND: The studies on cardiovascular alterations when using an N95 respirator or surgical mask-covered N95 during dental treatments are limited. AIM: To investigate and compare the cardiovascular responses of dentists treating paediatric patients while wearing an N95 respirator or a surgical mask-covered N95. DESIGN: This was a crossover clinical trial in 18 healthy dentists wearing an N95 respirator or surgical mask-covered N95 during the dental treatment of paediatric patients. Oxygen saturation (SpO2 ), heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were monitored at baseline, intraoperation, and postoperation. The data were analyzed using the generalized estimating equation. RESULTS: The mean SpO2 , HR, SBP, DBP, and MAP significantly changed from baseline up to the end of the procedures after wearing an N95 by 3.1%, 19.3%, 11.5%, 17.7%, and 13.8% and after wearing a surgical mask-covered N95 by 3.0%, 20.2%, 5.3%, 13.9%, and 8.8%, respectively (p < .05). No significant differences in these values were found between groups (p > .05). CONCLUSIONS: N95 respirators and surgical mask-covered N95s significantly impact the cardiovascular responses of dentists treating paediatric patients with no differences between the two types of masks.
Subject(s)
COVID-19 , Respiratory Protective Devices , Humans , Child , N95 Respirators , Masks/adverse effects , COVID-19/etiology , DentistsABSTRACT
Sauna bathing, a tradition deeply rooted in the Finnish culture, has been used for thousands of years for leisure, relaxation, and wellness. Sauna bathing is linked with substantial health benefits beyond its use for leisure and relaxation. Several observational and interventional studies suggest that regular or frequent sauna bathing reduces the incidence of vascular and nonvascular diseases, such as hypertension, cardiovascular disease, dementia, and respiratory conditions; may improve the severity of conditions such as musculoskeletal disorders, COVID-19, headache, and influenza; and increases the life span. The beneficial effects of sauna bathing on adverse outcomes have been linked to its blood pressure-reducing, anti-inflammatory, antioxidant, cytoprotective, and stress-reducing properties and its synergistic effect on neuroendocrine, circulatory, cardiovascular, and immune function. Evidence suggests that frequent sauna bathing is an emerging protective risk factor that may augment the beneficial effects of other protective risk or lifestyle factors, such as physical activity and cardiorespiratory fitness, or attenuate or offset the adverse effects of other risk factors, such as high blood pressure, systemic inflammation, and low socioeconomic status. This review summarizes the available epidemiologic and interventional evidence linking the combined effects of Finnish sauna bathing and other risk factors on vascular outcomes including cardiovascular disease and intermediate cardiovascular phenotypes, nonvascular outcomes, and mortality. We also discuss the mechanistic pathways underlying the joint contributions of Finnish sauna bathing and other risk factors on health outcomes, the public health and clinical implications of the findings, gaps in the existing evidence base, and future directions.
Subject(s)
COVID-19 , Cardiovascular Diseases , Hypertension , Steam Bath , Humans , Steam Bath/adverse effects , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/etiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/etiology , Hypertension/etiology , Inflammation/etiologyABSTRACT
The COVID-19 pandemic represents a global health problem, which has been mitigated by the opportune introduction of vaccination programs. Although we already know the benefit that vaccines provide, these are not exempt from adverse events which can be mild to deadly, such as idiopathic inflammatory myopathies, in which a temporal association has not been defined. It is for this reason that we carried out a systematic review of all reported cases of vaccination against COVID-19 and myositis. To identify previously reported cases of idiopathic inflammatory myopathies associated with vaccination against SARS-CoV-2 we registered this protocol on the website of PROSPERO with identification number CRD42022355551. Of the 63 publications identified in MEDLINE and 117 in Scopus, 21 studies were included, reporting 31 cases of patients with vaccination-associated myositis. Most of these cases were women (61.3%); mean age was 52.3 years (range 19-76 years) and mean time of symptom onset post-vaccination was 6.8 days. More than half of the cases were associated with Comirnaty, 11 cases (35.5%) were classified as dermatomyositis, and 9 (29%) as amyopathic dermatomyositis. In 6 (19.3%) patients another probable trigger was identified. Case reports of inflammatory myopathies associated with vaccination have heterogeneous presentations without any specific characteristics: as a consequence, it is not possible to ensure a temporal association between vaccination and the development of inflammatory myopathies. Large epidemiological studies are required to determine the existence of a causal association.
Subject(s)
COVID-19 , Myositis , Humans , Female , Infant, Newborn , Infant , Male , SARS-CoV-2 , Pandemics , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/etiology , Myositis/chemically induced , Myositis/epidemiology , Vaccination/adverse effectsABSTRACT
Background: Allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients must be vaccinated against SARS-CoV-2 as quickly as possible after transplantation. The difficulty in obtaining recommended SARS-CoV-2 vaccines for allo-HSCT recipients motivated us to utilize an accessible and affordable SARS-CoV-2 vaccine with a recombinant receptor-binding domain (RBD)-tetanus toxoid (TT)-conjugated platform shortly after allo-HSCT in the developing country of Iran. Methods: This prospective, single-arm study aimed to investigate immunogenicity and its predictors following a three-dose SARS-CoV-2 RBD-TT-conjugated vaccine regimen administered at 4-week (± 1-week) intervals in patients within 3-12 months post allo-HSCT. An immune status ratio (ISR) was measured at baseline and 4 weeks (± 1 week) after each vaccine dose using a semiquantitative immunoassay. Using the median ISR as a cut-off point for immune response intensity, we performed a logistic regression analysis to determine the predictive impact of several baseline factors on the intensity of the serologic response following the third vaccination dose. Results: Thirty-six allo-HSCT recipients, with a mean age of 42.42 years and a median time of 133 days between hematopoietic stem cell transplant (allo-HSCT) and the start of vaccination, were analyzed. Our findings, using the generalized estimating equation (GEE) model, indicated that, compared with the baseline ISR of 1.55 [95% confidence interval (CI) 0.94 to 2.17], the ISR increased significantly during the three-dose SARS-CoV-2 vaccination regimen. The ISR reached 2.32 (95% CI 1.84 to 2.79; p = 0.010) after the second dose and 3.87 (95% CI 3.25 to 4.48; p = 0.001) after the third dose of vaccine, reflecting 69.44% and 91.66% seropositivity, respectively. In a multivariate logistic regression analysis, the female sex of the donor [odds ratio (OR) 8.67; p = 0.028] and a higher level donor ISR at allo-HSCT (OR 3.56; p = 0.050) were the two positive predictors of strong immune response following the third vaccine dose. No serious adverse events (i.e., grades 3 and 4) were observed following the vaccination regimen. Conclusions: We concluded that early vaccination of allo-HSCT recipients with a three-dose RBD-TT-conjugated SARS-CoV-2 vaccine is safe and could improve the early post-allo-HSCT immune response. We further believe that the pre-allo-HSCT SARS-CoV-2 immunization of donors may enhance post-allo-HSCT seroconversion in allo-HSCT recipients who receive the entire course of the SARS-CoV-2 vaccine during the first year after allo-HSCT.
Subject(s)
COVID-19 Vaccines , COVID-19 , Hematopoietic Stem Cell Transplantation , Adult , Female , Humans , COVID-19/prevention & control , COVID-19/etiology , COVID-19 Testing , COVID-19 Vaccines/administration & dosage , Prospective Studies , SARS-CoV-2 , Tetanus ToxoidABSTRACT
Vulnerable patients such as immunosuppressed or elderly patients are at high risk for a severe course of COVID-19 upon SARS-CoV-2 infection. Immunotherapy with SARS-CoV-2 specific monoclonal antibodies (mAb) or convalescent plasma represents a considerable treatment option to protect these patients from a severe or lethal course of infection. However, monoclonal antibodies are not always available or less effective against emerging SARS-CoV-2 variants. Convalescent plasma is more commonly available and may represent a good treatment alternative in low-income countries. We retrospectively evaluated outcomes in individuals treated with mAbs or convalescent plasma and compared the 30-day overall survival with a patient cohort that received supportive care due to a lack of SARS-CoV-2 specific therapies between March 2020 and April 2021. Our data demonstrate that mAb treatment is highly effective in preventing severe courses of SARS-CoV-2 infection. All patients treated with mAb survived. Treatment with convalescent plasma improved overall survival to 82% compared with 61% in patients without SARS-CoV-2 targeted therapy. Our data indicate that early convalescent plasma treatment may be an option to improve the overall survival of high-risk COVID-19 patients. This is especially true when other antiviral drugs are not available or their efficacy is significantly reduced, which may be the case with emerging SARS-CoV-2 variants.
Subject(s)
COVID-19 , Humans , Aged , COVID-19/therapy , COVID-19/etiology , SARS-CoV-2 , Retrospective Studies , COVID-19 Serotherapy , Antibodies, Viral , Immunization, Passive/adverse effects , Antibodies, Neutralizing/therapeutic useABSTRACT
BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic has caused changes in the medical practice. However, it is unclear whether the patients receiving phototherapy for their dermatoses have been affected. OBJECTIVES: This study aimed to identify the impact of the COVID-19 pandemic on phototherapy, focusing on the patient profile, adherence, and attitude before and after the surge. METHODS: The study encompassed the time 5 months prior to and after the surge of the COVID-19 pandemic (from May to July, 2021), resulting in the temporary closure of our phototherapeutic unit. RESULTS: Nine hundred eighty-one patients received phototherapy during this period. Vitiligo, psoriasis (Ps), and atopic dermatitis (AD) represented the groups with the highest patient numbers. For vitiligo, Ps and AD, 39.6%, 41.9%, and 28.4% of the patients resumed phototherapy after the pandemic-related shutdown (PRS). No significant difference was noted in age, gender, and number of weekly sessions between those who resumed or stopped phototherapy after PRS among three groups. Patients who resumed phototherapy after PRS tended to receive more weekly sessions of phototherapy than those who initiated after PRS. Additionally, patients who resumed phototherapy showed no significant difference in the number of weekly sessions before and after PRS. CONCLUSIONS: This study reveals a significant impact of the COVID-19 pandemic on patients undergoing phototherapy. Although the patient number remained similar before and after PRS, a significant portion of patients discontinued phototherapy after PRS. New strategies and continued education are needed to improve patient management in times of pandemic.
Subject(s)
COVID-19 , Dermatitis, Atopic , Psoriasis , Ultraviolet Therapy , Vitiligo , Humans , Ultraviolet Therapy/methods , Taiwan/epidemiology , Pandemics , COVID-19/etiology , Phototherapy , Psoriasis/therapyABSTRACT
Importance: The aerosol box has been used during the management of patients with COVID-19 to reduce health care practitioner (HCP) exposure during aerosol-generating medical procedures (AGMPs). Little is known about the effect of aerosol box use on HCP contamination and AGMP procedure time. Objective: To investigate whether use of an aerosol box during AGMPs reduces HCP contamination or influences the time to successful completion and first-pass success rate for endotracheal intubation (ETI) and laryngeal mask airway (LMA) insertion. Design, Setting, and Participants: This multicenter, simulation-based, randomized clinical trial was conducted from May to December 2021 at tertiary care pediatric hospitals. Participant teams performed 3 simulated patient scenarios: bag-valve-mask ventilation, ETI, and LMA insertion. During the scenarios, aerosols were generated using Glo Germ. Teams of 2 HCPs were randomly assigned to control (no aerosol box) or intervention groups (aerosol box). Statistical analysis was performed from July 2022 to February 2023. Interventions: The aerosol box (or SplashGuard CG) is a transparent, plastic barrier covering the patient's head and shoulders with access ports allowing HCPs to manage the airway. Main Outcomes and Measures: The primary outcome was surface area of contamination (AOC) on participants. Secondary outcomes were time to successful completion and first-pass success rates for ETI and LMA insertion. Results: A total of 64 teams (128 participants) were enrolled, with data from 61 teams (122 participants) analyzed. Among the 122 participants analyzed, 79 (64.8%) were female and 85 (69.7%) were physicians. Use of an aerosol box was associated with a 77.5% overall decreased AOC to the torso (95% CI, -86.3% to -62.9%; P < .001) and a 60.7% overall decreased AOC to the facial area (95% CI, -75.2% to -37.8%; P < .001) in airway HCPs. There was no statistically significant difference in surface contamination after doffing personal protective equipment between groups. Time to completing ETI was longer in the aerosol box group compared with the control group (mean difference: 10.2 seconds; 95% CI, 0.2 to 20.2 seconds; P = .04), but there was no difference between groups for LMA insertion (mean difference: 2.4 seconds; 95% CI, -8.7 to 13.5 seconds; P = .67). Conclusions and Relevance: In this randomized clinical trial of aerosol box use in AGMPs, use of an aerosol box reduced contamination deposition on HCPs' torso and face predoffing; the use of an aerosol box delayed time to successful intubation. These results suggest that the incremental benefits of reduced surface contamination from aerosol box use should be weighed against delayed time to complete intubation, which may negatively affect patient outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT04880668.
Subject(s)
COVID-19 , Humans , Female , Child , Male , COVID-19/prevention & control , COVID-19/etiology , Respiratory Aerosols and Droplets , Intubation, Intratracheal/methods , Personal Protective Equipment , Health PersonnelABSTRACT
Exogenous estrogen is associated with reduced coronavirus disease (COVID) mortality in nonimmunosuppressed/immunocompromised (non-ISC) postmenopausal females. Here, we examined the association of estrogen or testosterone hormone replacement therapy (HRT) with COVID outcomes in solid organ transplant recipients (SOTRs) compared to non-ISC individuals, given known differences in sex-based risk in these populations. SOTRs ≥45 years old with COVID-19 between April 1, 2020 and July 31, 2022 were identified using the National COVID Cohort Collaborative. The association of HRT use in the last 24 months (exogenous systemic estrogens for females; testosterone for males) with major adverse renal or cardiac events in the 90 days post-COVID diagnosis and other secondary outcomes were examined using multivariable Cox proportional hazards models and logistic regression. We repeated these analyses in a non-ISC control group for comparison. Our study included 1135 SOTRs and 43 383 immunocompetent patients on HRT with COVID-19. In non-ISC, HRT use was associated with lower risk of major adverse renal or cardiac events (adjusted hazard ratio [aHR], 0.61; 95% confidence interval [CI], 0.57-0.65 for females; aHR, 0.70; 95% CI, 0.65-0.77 for males) and all secondary outcomes. In SOTR, HRT reduced the risk of acute kidney injury (aHR, 0.79; 95% CI, 0.63-0.98) and mortality (aHR, 0.49; 95% CI, 0.28-0.85) in males with COVID but not in females. The potentially modifying effects of immunosuppression on the benefits of HRT requires further investigation.
Subject(s)
COVID-19 , Cardiovascular Diseases , Organ Transplantation , Male , Female , Humans , Middle Aged , COVID-19/epidemiology , COVID-19/etiology , Hormone Replacement Therapy/adverse effects , Organ Transplantation/adverse effects , Cardiovascular Diseases/etiology , Estrogens , Transplant RecipientsABSTRACT
PURPOSE OF REVIEW: Coronavirus disease 2019 (COVID-19) vaccination is considered one of the most promising and socioeconomically sustainable strategy to help control the pandemic and several vaccines are currently being distributed in nationwide mass immunization campaigns. Very limited data are available on benefits and risks of COVID-19 vaccination in immunocompromised patients and in particular in solid organ or hematopoietic stem cell transplant recipients as they were excluded from phase III trials. This review summarizes current knowledge, international guidelines and controversies regarding COVID-19 vaccination in these vulnerable populations. RECENT FINDINGS: Various COVID-19 vaccine platforms showed good efficacy in phase III trials in the immunocompetent and there are data arising on the safety and immunogenicity of these vaccines in the immunocompromised population. SUMMARY: Transplant recipients could benefit significantly from COVID-19 vaccination, both through active immunization provided they elicit protective vaccine responses, and probably through cocooning by immunization of caregivers and healthcare personnel and thus reducing the risk of SARS-coronavirus-2 exposure. Although awaiting more data on the safety and efficacy of COVID-19 vaccines to inform potential adaptations of vaccine regimens, we strongly recommend prioritizing COVID-19 vaccination of solid and hematopoietic stem cell transplant recipients to decrease COVID-19-related morbidity and mortality.
Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , SARS-CoV-2/immunology , Transplant Recipients , COVID-19/etiology , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/classification , Clinical Decision-Making , Disease Management , Hematopoietic Stem Cell Transplantation/adverse effects , Humans , Immunocompromised Host , Immunogenicity, Vaccine , Organ Transplantation/adverse effects , Organ Transplantation/methods , Outcome Assessment, Health Care , VaccinationABSTRACT
Within the first 4 months of the Western Australian COVID-19 immunisation programme, 49 suspected anaphylaxis cases were reported to the vaccine safety surveillance system. Twelve reports met Brighton Collaboration case definition, corresponding to rates of 15.9 and 17.7 per million doses of Vaxzevria and Comirnaty administered respectively.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Humans , Adverse Drug Reaction Reporting Systems , Anaphylaxis/etiology , Australia/epidemiology , BNT162 Vaccine , ChAdOx1 nCoV-19 , COVID-19/etiology , COVID-19 Vaccines/adverse effects , Vaccination/adverse effects , Western AustraliaABSTRACT
BACKGROUND: Treatment options for patients with COVID-19-related acute respiratory distress syndrome (ARDS) are desperately needed. Allogeneic human umbilical cord derived mesenchymal stromal cells (hCT-MSCs) have potential therapeutic benefits in these critically ill patients, but feasibility and safety data are lacking. MATERIALS AND METHODS: In this phase I multisite study, 10 patients with COVID-19-related ARDS were treated with 3 daily intravenous infusions of hCT-MSCs (1 million cells/kg, maximum dose 100 million cells). The primary endpoint assessed safety. RESULTS: Ten patients (7 females, 3 males; median age 62 years (range 39-79)) were enrolled at 2 sites and received a total of 30 doses of study product. The average cell dose was 0.93 cells/kg (range 0.56-1.45 cells/kg and total dose range 55-117 million cells) with 5/30 (17%) of doses lower than intended dose. Average cell viability was 85% (range 63%-99%) with all but one meeting the >70% release criteria. There were no infusion-related reactions or study-related adverse events, 28 non-serious adverse events in 3 unique patients, and 2 serious adverse events in 2 unique patients, which were expected and unrelated to the study product. Five patients died: 3 by day 28 and 5 by day 90 of the study (median 27 days, range 7-76 days). All deaths were determined to be unrelated to the hCT-MSCs. CONCLUSION: We were able to collect relevant safety outcomes for the use of hCT-MSCs in patients with COVID-19-related ARDS. Future studies to explore their safety and efficacy are warranted.
Subject(s)
COVID-19 , Mesenchymal Stem Cell Transplantation , Mesenchymal Stem Cells , Respiratory Distress Syndrome , Male , Female , Humans , Adult , Middle Aged , Aged , COVID-19/therapy , COVID-19/etiology , Feasibility Studies , Mesenchymal Stem Cell Transplantation/adverse effects , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapyABSTRACT
This 16-month-long multicentre retrospective study of 225 allogeneic haematopoietic stem cell transplantation (alloHSCT) recipients with COVID-19 examines risk factors for severity and mortality, describing the successive waves of infections (from March to June 2020 and from August 2020 to June 2021). We confirm the negative role of low respiratory tract disease and immunosuppressive treatment. We highlight significantly lower percentages of severe forms and COVID-19-related mortality during the second wave. Monthly comparative evolution of cases in alloHSCT recipients and in the French population shows a higher number of cases in alloHSCT recipients during the first wave and a decrease from February 2021.
Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Humans , Retrospective Studies , Hematopoietic Stem Cell Transplantation/adverse effects , COVID-19/etiology , Immunosuppressive Agents/adverse effects , Risk FactorsABSTRACT
BACKGROUND: During the coronavirus disease 2019 (COVID-19) pandemic the standard inpatient care of patients was restricted to increase overall and intensive care capacity reserves for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected persons. OBJECTIVE: This article presents the impact of the COVID-19 pandemic on the surgical and postoperative care of bariatric patients in Germany. MATERIAL AND METHODS: A statistical analysis of the national StuDoQ/MBE register data for the period from 1 May 2018 until 31 May 2022 was performed. RESULTS: Throughout the entire study period there was a continuous increase in documented operations, which continued even during the COVID-19 pandemic. A significant intermittent decline in surgery performed was observed only during the imposition of first lockdown in the months of March to May 2020, with a minimum number of 194 cases performed monthly in April 2020. The pandemic had no measurable effect on the surgically treated patient population, the type of surgical procedure, the perioperative and postoperative outcomes and follow-up care. CONCLUSION: Based on the results of the StuDoQ data and the current literature, it can be deduced that bariatric surgery can be carried out with no increased risk during the COVID-19 pandemic and the quality of postoperative care is not impaired.
Subject(s)
Bariatric Surgery , COVID-19 , Humans , COVID-19/epidemiology , COVID-19/etiology , Pandemics , SARS-CoV-2 , Communicable Disease Control , Germany/epidemiologyABSTRACT
Allogeneic transplantation (allo-HCT) is a curative treatment in CLL whose efficacy including the most severe forms had led to the 2006 EBMT recommendations. The advent after 2014 of targeted therapies has revolutionized CLL management, allowing prolonged control to patients who have failed immunochemotherapy and/or have TP53 alterations. We analysed the pre COVID pandemic 2009-2019 EBMT registry. The yearly number of allo-HCT raised to 458 in 2011 yet dropped from 2013 onwards to an apparent plateau above 100. Within the 10 countries who were under the EMA for drug approval and performed 83.5% of those procedures, large initial differences were found but the annual number converged to 2-3 per 10 million inhabitants during the 3 most recent years suggesting that allo-HCT remains applied in selected patients. Long-term follow-up on targeted therapies shows that most patients relapse, some early, with risk factors and resistance mechanisms being described. The treatment of patients exposed to both BCL2 and BTK inhibitors and especially those with double refractory disease will become a challenge in which allo-HCT remains a solid option in competition with emerging therapies that have yet to demonstrate their long-term effectiveness.
Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Leukemia, Lymphocytic, Chronic, B-Cell , Humans , Leukemia, Lymphocytic, Chronic, B-Cell/therapy , Hematopoietic Stem Cell Transplantation/methods , Neoplasm Recurrence, Local , COVID-19/etiology , Transplantation, Homologous/methods , Transplantation Conditioning/methods , Retrospective StudiesABSTRACT
Introduction: Long COVID is the overarching name for a wide variety of disorders that may follow the diagnosis of acute SARS-COVID-19 infection and persist for weeks to many months. Nearly every organ system may be affected. Methods: We report nine patients suffering with Long COVID for 101 to 547 days. All exhibited significant perturbations of their immune systems, but only one was known to be immunodeficient prior to the studies directed at evaluating them for possible treatment. Neurological and cardiac symptoms were most common. Based on this data and other evidence suggesting autoimmune reactivity, we planned to treat them for 3 months with long-term high-dose immunoglobulin therapy. If there was evidence of benefit at 3 months, the regimen was continued. Results: The patients' ages ranged from 34 to 79 years-with five male and four female patients, respectively. All nine patients exhibited significant immune perturbations prior to treatment. One patient declined this treatment, and insurance support was not approved for two others. The other six have been treated, and all have had a significant to remarkable clinical benefit. Conclusion: Long-term high-dose immunoglobulin therapy is an effective therapeutic option for treating patients with Long COVID.