Coeliac disease in the COVID-19 pandemic: does HLA have a protective effect?

BACKGROUND: The coronavirus disease 2019 (COVID-19), an acute respiratory disease caused by a novel coronavirus (SARS-CoV-2), is emerging as a worldwide public health emergency. Several scientific contributions reported the potential relevance of human leukocyte antigen (HLA) polymorphism and susceptibility to viruses, such as SARS-CoV. In our study, we examined a population of coeliac subjects presenting the HLA haplotype DQ2 and/or DQ8. Our aim was to evaluate whether HLA DQ2 and/or DQ8 haplotype play a role in SARS-CoV-2-infection. The aim was also to evaluate the difficulty in following the gluten-free diet due to all the adversities produced by the pandemic, such as the food supply disruption, and the difficulties in managing the clinical follow-up. METHODS: 191 consecutive coeliac patients completed a questionnaire on their current clinical status, psychological effects, and management of the gluten-free diet experienced during the COVID-19 pandemic and questions regarding possible SARS-CoV-2 infection. RESULTS: Out of the 191 patients who participated in the study, 42 were full-blown coeliac and 149 were in remission. From the answers provided, 84.8% of patients declared that they no longer consider themselves vulnerable to COVID-19 as they suffer from coeliac disease; 94.2% of patients did not encounter any difficulties in managing the gluten-free diet or in acquiring specific foods and 64.9% of patients in our study underwent diagnostic testing for SARS-CoV-2. Out of this number, 31.5% did so due to contacts with subjects affected by COVID-19, 26.6% for work related reasons, 11.3% due to flu-like symptoms and 30.6% for other reasons. Only 5.8% of the enrolled patients received a diagnosis of COVID-19. Out of all the patients in our population who were diagnosed with COVID-19, 94.8% developed no symptoms and none of them needed hospitalization or intensive care. CONCLUSION: The hypothesis that the HLADQ2 and/or DQ8 haplotype plays a protective role against SARS-CoV-2 infection, as against other viral infections, is intriguingly suggestive.KEY MESSAGESCOVID-19 as a public health emergency;SARS-CoV-2 and possible complications in coeliac disease;Role of HLA DQ2 and/or DQ8 in SARS-CoV-2 infection.

Why do prostate cancer clinical trials (CT) discontinue prematurely in the era of COVID-19? An analysis of 559 CT from ClinicalTrial.gov

Background: The COVID-19 pandemic (C19P) is producing several detrimental effects on cancer care globally. CT play a decisive role to provide high quality literature evidence and “poor accrual” is the most common reason for their early discontinuation (ED). At our best knowledge, no data are available on ED of prostate cancer CT after the beginning of C19P. Material and methods: ClinicalTrial.gov was queried for terminated (T), withdrawn (W) and suspended (S) CT for the following terms: “cancer”, “neoplasm” and “tumor”. CT not related on prostate cancer were excluded. The search was made for all the CT available from the inception to 26th February 2021, without any restrictions. The following characteristics were extracted: reason for ED, study type (interventional [In] vs observational), sponsor (yes vs not). ED rate was compared between CT discontinued for C19P or not (χ2);p < 0.05 was set as statistically significant. A multiple linear regression analysis was also conducted to identify independent factors of ED. Results: 9990 CT were identified and 7901 CT were excluded because not related to prostate cancer. Thus, 559 CT were included: 67% was T, 27% was W and 5% was S. Among CT classified as T, W and S, the frequency of In CT were 90%, 82% and 81% respectively, while the frequency of sponsored CT was 48%, 27% and 19% respectively. The most common reasons for ED were: “poor accrual” (31%), “lack of funding” (7%) and “sponsor decision” (5%). No reason for ED was available for 13% of CT. Ten (2%) CT were discontinued for C19P (20% was T, 10% was W and 70% was S). Comparing CT discontinued due to C19P with those discontinued due to other causes, a lower rate of In-CT (88% vs 91%, p<0.05) was found in the C19P group. At the multiple linear regression analysis, it was found that C-19 was strongly positively correlated with ED (coefficient 0,62677, p<0.0001) whereas sponsored CT resulted negatively correlated with ED (coefficient -0,03717, p=0.0369). Conclusions: “Poor accrual” continues to be the main reason for ED of cancer CT, whereas C19P represents a new additional cause of ED. Sponsored trials showed less risk for ED. Further research is needed to maximize the expected benefit of cancer CT, reducing the anticipated risks.

Why do cancer clinical trials (CT) discontinue prematurely in the era of COVID-19?

Background: The COVID-19 pandemic (C19P) is causing several detrimental effects on cancer care globally. CT are crucial to obtain high quality literature evidence and “poor accrual” is the most common reason for their early discontinuation (ED). At our best knowledge, no data are available on ED of cancer CT after the beginning of C19P. Methods: ClinicalTrial.gov was queried for terminated (T), withdrawn (W) and suspended (S) CT for the following terms: “cancer”, “neoplasm”, and “tumor”. The search was made for all the CT available from the inception to 26th February 2021, without any restrictions. The following characteristics were extracted: reason for ED, study type (interventional [In] vs observational), sponsored (yes vs not). ED rate was compared between CT discontinued for C19P or not (χ2);p<0.05 was set as statistically significant. A multiple linear regression analysis was also conducted to identify independent factors of ED. Results: 9990 CT were identified, but 765 CT were excluded as not related to cancer. Thus, 9225 CT were included (66% was T, 23% was W and 4% was S). Among CT classified as T, W and S, the frequency of In CT was 92%, 88% and 85% respectively, while the frequency of sponsored CT was 46%, 35% and 26% respectively. The most common reasons for ED were: “poor accrual” (29%), “lack of funding” (6%) and “sponsor decision” (5%). No reason for ED was available for 15% of CT. One hundred (1%) CT were discontinued due to C19P (27% was T, 7% was W and 66% was S). Comparing CT discontinued due to C19P with those discontinued due to other reasons, a lower rate of In-CT (73% vs 91%, p<0.05) and sponsored CT (14% vs 42%, p<0.05) was found in the C19P group. At the multiple linear regression analysis, C19P was strongly positively correlated with ED (coefficient 0.59952, p<0.0001) whereas sponsored CT resulted as negatively correlated with ED (coefficient -0.02746, p<0.0001). Conclusions: “Poor accrual” continues to be the main reason for ED of cancer CT, but C19P represents a new additional cause of ED. Sponsored trials showed less risk for ED. Further research is needed to maximize the expected benefit of cancer CT, reducing the anticipated risks. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.