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

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.

Regional Trends in Favipiravir and Steroid Use in the Treatment of COVID-19

Background. Two years have passed since the global outbreak of COVID-19 began. Vaccines and many therapeutic agents have now been developed, and treatment is being conducted in accordance with guidelines. In general, it takes a long time for guidelines to be established, as a large amount of clinical data is required. Therefore, in the early and middle stages of an epidemic, treatment is often based on experience at individual centers. This study focuses on two drugs, Favipiravir and Steroid, and investigates how trends in drug use changed in different regions. Methods. We compared the proportion of drug administered patients in the COVID-19 Registry Japan (COVIREGI-JP). Data from four COVID-19 epidemic waves, from January 2020 to June 2021, were included for the analysis. To compare regional trends, 10 categories were used based on existing classifications. In addition, Tokyo and Osaka were accounted for separately, for a total of 12 regions. Severity of each case was divided into mild, moderate 1, moderate 2 and severe based on the condition on admission, and the proportion of Favipiravir or Steroid administered cases was calculated for moderate 2 and severe cases. Results. Favipiravir was administered to more than 50-100% of patients in the first wave. Thereafter, it declined nationwide, with sharp falls in Tokyo (34.9%, 16.5% and 4.3%) and Osaka (48.8%, 41.8% and 8.0%). In Hokkaido, on the other hand, 82.4%, 53.7% and 59.8% of the cases still continued to receive Favipiravir. In the first wave, Steroid was administered to 20-40% of cases. The proportion gradually increased, with 50-80% in the second wave, and 85.5% in Tokyo, 93.4% in Osaka and 90.2% in Hokkaido in the fourth wave, the majority of cases. Changes over time in the proportions of cases treated with Favipiravir and Steroid in each region. The top four and middle four panels show the proportion of cases treated with Favipiravir and Steroid, respectively. The lower epi-curve shows the number of COVID-19 cases in Japan. Conclusion. We confirmed that the more effective treatment was rapidly spreading throughout the country. More information is available in areas with a large number of cases, such as Tokyo and Osaka, and in facilities that see a large number of cases. On the other hand, it may be difficult for smaller facilities or facilities that do not see many COVID-19 cases. Information from registry studies would be useful in making more effective treatments available earlier and more widely. We believe that further use of COVIREGI-JP would promote standardization of treatment.

International Multicenter Study to Investigate the Performance of Urinary L-FABP in Predicting COVID-19 Severity

Background: Early detection of the illness trajectory in SARS-CoV-2 infected patients is crucial for patients and healthcare workers. A practical, non-invasive approach, with simple measurement for decision-making, is necessary for a pandemic to discriminate between high and low-risk patients, even though both may appear mild initially. Method(s): To determine COVID-19 disease severity within 10-days, distinguishing severe vs. moderate+mild and severe+moderate vs. mild, urinary L-type fatty acidbinding protein (L-FABP) was assayed less than four days after receiving a diagnosis. Severity was divided into mild (without oxygen), moderate (with oxygen) and severe (IMV/ECMO), and L-FABP within four days of diagnosis were used to predict severity within 10 days after onset. For risk prediction, urinary L-FABP was compared with interleukin-6. Next, the L-FABP point-of-care test (POCT) was further examined for its utility in risk screening in the international multicenter study. Result(s): Of the 224 participants in the study, 173 initially had a mild form. The AUC for a severe outcome was 96.3% in creatinine-adjusted L-FABP and 93.5% in net value. The AUC for a mild outcome was 85.0% and 84.9% net. The predictability of L-FABP for either a severe or mild outcome was superior to that of IL-6. Dynamics further showed better predictability of L-FABP than IL-6 during 10-days after onset. Finally, a multicenter-multicountry study confirmed the L-FABP POCT risk prediction of a severe outcome with an AUC of 88.9% and a mild outcome of 68.5%. Conclusion(s): Urinary L-FABP can predict the patient's risk of illness severity in COVID-19. L-FABP may detect severe cases more effectively and earlier than IL-6. L-FABP POCT is implementable for patient management.

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 fever, 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.

Can urine biomarkers predict severity of COVID-19? A preliminary study

Background: Early detection of coronavirus disease (COVID-19) in patients likely to develop severe manifestations enables appropriate interventions, including rapid intensive care unit admission. This study was conducted to determine whether noninvasive urine biomarkers can predict the clinical severity of COVID-19. Methods: Design A retrospective case series. Setting Single-center study, national center hospital designated for infectious disease. Patients Fifty-eight patients who tested positive for SARS-CoV-2 in respiratory specimens through real-time reverse transcription-polymerase chain reaction (RT-PCR) were retrospectively studied. Measurements and main results Urinary β2-microglobulin (β2MG), liver-type fatty acid-binding protein (L-FABP) were serially measured. Serum interferon γ and monocyte chemotactic protein-1 were also evaluated. Results: The 58 patients were assigned into three groups. Patients requiring intensive care were assigned to the severe group (N = 12). Patients treated with oxygen were assigned to the moderate group (N = 13). Other patients were assigned to the mild group (N = 33). Urine tests revealed that low β2MG and L-FABP levels on admission were associated with mild disease, whereas high levels were associated with severe disease. In severe cases, L-FABP tended to be persistently high. The resulting cutoff values were β2MG;Severe vs. Moderate+Mild: 2457 μg/dL (Specificity 76.9% and Sensitivity 90.0%, AUC 85.9%), L-FABP;Severe vs. Moderate+Mild: 22.0 μg/gCre (Specificity 84.6% and Sensitivity 90%, AUC 91.8%). Urinary β2MG and serum IFN-γ/MCP-1 showed a similar trend. Conclusions: Evaluating urinary biomarkers such as β2MG and L-FABP may allow determination of COVID-19 patients with active cytokines and recognition of patients likely to become critically ill and requiring careful observation and early intervention.