ABSTRACT
BACKGROUND: Given the increasing health concerns for patients with inflammatory bowel disease (IBD), amidst the COVID-19 pandemic, we investigated the impact of the pandemic on the anxiety and behavioral changes in Japanese patients with IBD. METHODS: We analyzed 3032 questionnaires from patients with IBD, aged 16 years or older visiting 30 hospitals and 1 clinic between March 2020 and June 2021. The primary outcome was the score of the anxiety experienced by patients with IBD during the pandemic. RESULTS: Participants reported a median age of 44 years; 43.3% of the patients were women. Moreover, 60.6% and 39.4% were diagnosed with ulcerative colitis and Crohn's disease, respectively, with a median disease duration of 10 years. Participants indicated an average of disease-related anxiety score of 5.1 ± 2.5 on a ten-point scale, with a tendency to increase, 1 month after the number of infected persons per population increased. The top three causes for anxiety were the risk of contracting COVID-19 during hospital visits, SARS-CoV-2 infection due to IBD, and infection by IBD medication. Factors associated with anxiety were gender (women), being a homemaker, hospital visit timings, mode of transportation (train), use of immunosuppressive drugs, and nutritional therapy. Most patients continued attending their scheduled hospital visits, taking their medications, experienced the need for a family doctor, and sought guidance and information regarding COVID-19 from primary doctors, television, and Internet news. CONCLUSIONS: Patients with IBD experienced moderate disease-related anxiety due to the pandemic and should be proactively informed about infectious diseases to relieve their anxiety.
Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Adult , Female , Humans , Male , Anxiety/epidemiology , Anxiety/etiology , COVID-19/epidemiology , East Asian People , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/epidemiology , Inflammatory Bowel Diseases/therapy , PandemicsABSTRACT
BACKGROUND: The spread of coronavirus disease 2019 (COVID-19) had a major impact on the health of people worldwide. The clinical background and clinical course of inflammatory bowel disease (IBD) among Japanese patients with COVID-19 remains unclear. METHODS: This study is an observational cohort of Japanese IBD patients diagnosed with COVID-19. Data on age, sex, IBD (classification, treatment, and activity), COVID-19 symptoms and severity, and treatment of COVID-19 were analyzed. RESULTS: From 72 participating facilities in Japan, 187 patients were registered from June 2020 to October 2021. The estimated incidence of COVID19 in Japanese IBD patients was 0.61%. The majority of IBD patients with COVID-19 (73%) were in clinical remission. According to the WHO classification regarding COVID-19 severity, 93% (172/184) of IBD patients had non-severe episodes, while 7% (12/184) were severe cases including serious conditions. 90.9% (165/187) of IBD patients with COVID-19 had no change in IBD disease activity. A logistic regression analysis stepwise method revealed that older age, higher body mass index (BMI), and steroid use were independent risk factors for COVID-19 severity. Six of nine patients who had COVID-19 after vaccination were receiving anti-tumor necrosis factor (TNF)-α antibodies. CONCLUSION: Age, BMI and steroid use were associated with COVID-19 severity in Japanese IBD patients.
Subject(s)
COVID-19 , Inflammatory Bowel Diseases , COVID-19/epidemiology , Humans , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/epidemiology , Japan/epidemiology , Registries , SARS-CoV-2ABSTRACT
Condition:
COVID-19Intervention:
Inoculate KD-414 or placebo intramuscularly 2 doses of 0.5 mL at intervals of 27 days.At 26 weeks after the second dose of the investigational product, 0.5 mL will be inoculated intramuscularly.
Primary outcome:
Neutralizing antibody conversion rate against SARS-CoV-2 at 28 days after the second dose of study product in each group
The incidence and causal relationship to the study products of all adverse events, adverse events resulting in death, serious adverse events other than death, important adverse events, and severe (Grade 3 or higher) adverse events occurring after the first dose of study product to the examination 28 days after the second dose in each group
The incidence and causal relationship to the study products of adverse events resulting in death, serious adverse events other than death, and severe (Grade 3 or higher) adverse events occurring after the examination 28 days after the second dose to the completion of follow-up in each group
The incidence, severity, number of days to onset, duration, incidence by the first/second dose, and causal relationship to the study products of solicited local adverse events in each group
The incidence, severity, number of days to onset, duration, incidence by the first/second dose, and causal relationship to the study products of solicited systemic adverse events in each group
The incidence, severity, number of days to onset, duration, incidence by the first/second dose, and causal relationship to the study products of unsolicited adverse events in each group
The highest body temperature between each administration of the study product and 6 days post-injection in each group
Criteria:
Inclusion criteria:1) Healthy adults aged >=20 years to <65 years at the informed consent and at the first dose of study product (regardless of sex), and
2) Those who have provided a written informed consent.
1) Healthy elderly subjects aged >=65 years at the first dose of study product (regardless of sex), and
2) Those who have provided a written informed consent.
Exclusion criteria: 1) Subjects who tested positive for COVID-19 by a PCR test at screening,
2) Subjects with COVID-19, or have a history of COVID-19 (based on the interview with subject),
3) Close contacts with patients with COVID-19 (based on the interview with subject),
4) Subjects with a history of overseas travel in and after January 2020 (based on the interview with subject),
5) Subjects who have been received any vaccines against COVID-19 (including unapproved drugs),
6) Subjects who have experienced documented anaphylaxis caused by an ingredient of the study product,
7) Pregnant or possibly pregnant women, women desiring to become pregnant before the end of the examination 28 days after the second dose, and breastfeeding women,
8) Patients with progressive ossifying fibrodysplasia,
9) Patients having an underlying disease, such as serious cardiovascular diseases, serious renal diseases, serious hepatic diseases, serious hematological diseases, serious developmental disorders, serious respiratory diseases, serious diabetes mellitus, etc.,
10) Subjects having experienced pyrexia or symptoms suggesting allergy, such as generalized exanthema, within 2 days after immunization (not applicable if the causative ingredient is confirmed not included in the study product),
11) Subjects with a history of convulsions,
12) Subjects having been diagnosed with immunodeficiency or having a close relative with congenital immunodeficiency,
13) Subjects possibly being allergic to any ingredient of the study product,
14) Subjects who participated in another clinical trial and have received another investigational product (excluding placebo) within 4 months (120 days) prior to the date of the first dose of study product in this study, or those who plan to participate in another clinical trial during their participation in this study,
15) Subjects who have received transfusion or a gamma globulin preparation within 3 months (90 days), or a bolus therapy (>=200 mg/kg) with a gamma globulin preparation within 6 months (180 days), prior to the date of the first dose of study product,
16) Subject who have received any treatments that may affect the immune function within 6 months (180 days) prior to the date of the first dose of study product, including radiotherapy, immunosuppressants (except for external use), immunosuppressive therapy, antirheumatics, adrenocorticotropic hormones, or corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/day for >=14 days, except for external use.),
17) Subjects who are judged by the principal investigator or the subinvestigator as ineligible for the study as a result of the screening test, or
18) Subject being otherwise ineligible for this study in the principal investigator's or subinvestigator's opinion.
ABSTRACT
BACKGROUND: The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emerged as a dramatic challenge for all healthcare systems worldwide. This outbreak immediately affected gastroenterologists as well as global physicians worldwide because COVID-19 can be associated with not only triggering respiratory inflammation but also gastrointestinal (GI) inflammation based on the mechanism by which SARS-CoV-2 enters cells via its receptor the angiotensin-converting enzyme 2, which is expressed on GI cells. However, the comorbidity spectrum of digestive system in patients with COVID-19 remains unknown. Because the inflammatory bowel disease (IBD) management involves treating uncontrolled inflammation with immune-based therapies, physicians, and patients have great concern about whether IBD patients are more susceptible to SARS-CoV-2 infection and have worsened disease courses. SUMMARY: It is necessary to precisely ascertain the risk of SARS-CoV-2 infection and the COVID-19 severity in IBD patients and to acknowledge the IBD management during the COVID-19 pandemic with clinically reliable information from COVID-19 cohorts and IBD experts' opinions. In this review, we highlight clinical questions regarding IBD management during the COVID-19 pandemic and make comments corresponding to each question based on recent publications. Key Messages: We propose that there is (1) no evidence that IBD itself increases the risk of SARS-CoV-2 infection, (2) to basically prioritize the control of disease activity of IBD, (3) no need for physicians to suddenly discontinue immunomodulatory or biologic therapy in patients with quiescent IBD, and (4) a need for careful observation of elderly (>60 years old) and IBD patients receiving corticosteroid treatment during the COVID-19 pandemic.
Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Aged , Expert Testimony , Humans , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/epidemiology , Japan/epidemiology , Middle Aged , Pandemics , SARS-CoV-2ABSTRACT
All gastrointestinal endoscopic procedures have a high risk of aerosol contamination of the coronavirus disease 2019 (COVID-19) to endoscopists, nurses, and healthcare assistants. Given the current pandemic situation of COVID-19, the Japan Gastroenterological Endoscopy Society issued the recommendation for gastrointestinal (GI) endoscopy based on the status of COVID-19 as of April 9, 2020, in Japan: (i) indications for GI endoscopy in the pandemic of COVID-19; (ii) practical protective equipment for medical personnel depending on the risk for COVID-19; (iii) preprocedural management, such as pharyngeal local anesthesia using lidocaine spray which has a potential to generate the aerosols; (iv) ideal settings of the endoscopy room including the numbers of the staff and the patients; (v) postprocedural management, such as undressing and follow-up of the patients, as well as the involved staff, were documented to fit the practical scenarios in GI endoscopy, with the available data in Japan and the world. We believe that certain measures will prevent further spread of COVID-19.
Subject(s)
Coronavirus Infections/prevention & control , Endoscopy, Gastrointestinal/standards , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Pandemics/prevention & control , Personal Protective Equipment/statistics & numerical data , Pneumonia, Viral/prevention & control , Practice Guidelines as Topic , COVID-19 , Female , Humans , Infection Control/methods , Japan , Male , Occupational Health , Societies, MedicalABSTRACT
Some situations may require endoscopy during the COVID-19 (Coronavirus Disease 2019) pandemic. Here, we describe the necessary precautions in the form of clinical questions and answers (Q&A) regarding the safe deployment of gastrointestinal endoscopy in such situations while protecting endoscopy staff and patients from infection. Non-urgent endoscopy should be postponed. The risk of infection in patients should be evaluated in advance by questionnaire and body temperature. The health of staff must be checked every day. Decisions to employ endoscopy should be based on the institutional conditions and aims of endoscopy. All endoscopic staff need to wear appropriate personal protective equipment (PPE). The endoscope and other devices should be cleaned and disinfected after procedures in accordance with the relevant guidelines. Optimal management of the endoscopy unit is required. Endoscopy for infected patients or those with suspected infection demands exceptional caution. When a patient who undergoes endoscopy is later found to have COVID-19, the members of staff involved are considered exposed to the virus and must not work for at least 14 days if their PPE is considered insufficient. When PPE resources are limited, some equipment may be used continuously throughout a shift as long as it is not contaminated. Details of the aforementioned protective measures are described.
Subject(s)
Coronavirus Infections/prevention & control , Endoscopy, Gastrointestinal/methods , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Pandemics/prevention & control , Personal Protective Equipment/statistics & numerical data , Pneumonia, Viral/prevention & control , COVID-19 , Coronavirus Infections/epidemiology , Endoscopy, Gastrointestinal/adverse effects , Female , Humans , Infection Control/methods , Male , Occupational Health , Pandemics/statistics & numerical data , Pneumonia, Viral/epidemiology , Safety Management , Surveys and QuestionnairesABSTRACT
COVID-19 is rapidly spreading worldwide and specific literature how to deal with inflammatory bowel diseases (IBD) patients is limited so far. Here, the World Endoscopy Organisation is providing practical advice for the management of IBD patients during the pandemic covering the diagnostic and therapeutic spectrum.