Category: Covid-19

Participants and data collection

The online survey was conducted on May 11-12, 2020 (Phase 1), June 1420, 2021 (Phase 2), and May 1330, 2022 (Phase 3). Phase 1 was undertaken during the first state of emergency, while Phase 2 was carried out during the third state of emergency. The online survey in Phase 1 was conducted among residents in seven prefectures in which the state of emergency was declared relatively early (Tokyo, Kanagawa, Osaka, Saitama, Chiba, Hyogo, and Fukuoka prefectures) to accurately assess its impact. The inclusion criteria were as follows: (a) residents of the seven prefectures, and (b) aged 18 years or older. The exclusion criteria were as follows: (a) under 18 years of age, (b) high school students, and (c) living outside the seven prefectures. Phase 1 had 11,333 participants, with the number of participants from each prefecture based on the ratio of the number of people residing in each prefecture (Tokyo: n=2783, 24.6%; Kanagawa: n=1863, 16.4%; Osaka: n=1794, 15.8%; Saitama: n=1484, 13.1%; Chiba: n=1263, 11.1%; Hyogo: n=1119, 9.9%; Fukuoka: n=1027, 9.1%). In Phase 2, residents living in Kanagawa, Saitama, and Chiba prefectures, where the emergency declaration did not apply, were excluded from the survey, and 4,592 residents of Tokyo, Osaka, Hyogo, and Fukuoka participated in the follow-up survey. In Phase 3, an additional follow-up survey was conducted with some participants who had participated in Phase 2 (N=3892).

Study participants were recruited through Macromill Inc. (Tokyo, Japan), a global marketing research company. The company has more than 1.3 million registered members from all prefectures in Japan, with diverse characteristics (e.g., both genders, a wide range of age groups, and occupational statuses). The online survey system automatically eliminated duplicate responses from single respondents. A recruitment invitation was sent via e-mail to approximately 80,000 registered respondents living in the target area, and data were collected online. Upon receiving the link, participants completed an online survey voluntarily and anonymously, after providing informed consent online. Participants were given a clear explanation of the survey procedures and the release of data in a form that did not identify individuals and had the option to discontinue or terminate the survey at any time without providing a reason. Except for the default items provided by Macromill (gender, age, occupation, household income, marital status, and presence of children), the survey format did not allow participants to proceed to the next page if there were unanswered items. In addition, all participants were awarded Macromill points that they could exchange for prizes or cash.

This study was approved by the Research Ethics Committee of the Graduate School of Social and Industrial Science and Technology at Tokushima University (Approval No. 212). This study was conducted in accordance with the ethical standards of the 1964 Declaration of Helsinki and its amendments.

Sociodemographic information, including age, gender, employment status, marital status, and household income, was collected from participants. To discuss groups assumed to be vulnerable to lockdown in previous studies in the early stages of the pandemic9,10,11,12, information was collected on whether the individual or family member was a healthcare worker and whether the individual was currently or had previously been treated for mental health problems, severe physical illnesses, or COVID-19.

The Japanese version of the Kessler Psychological Distress Scale-6 (K6)13, a nonspecific psychological stress scale comprising six items, was used to measure psychological distress over the past 30 days. Each question was rated on a scale of 0 (never) to 4 (always), with total scores ranging from 0 to 24. The K6 is regarded as an ideal instrument for screening mental disorders in population-based health surveys because of its high accuracy and brevity13,14,15.

We adopted a threshold of five points commonly used to screen for mild-to-moderate mood/anxiety disorders16. Scores ranging from 5 to 12 indicated mild-to-moderate psychological distress. This is the optimal lower threshold for screening for moderate psychological distress16. Mild-to-moderate psychological distress is considered because of the associated risk of progression to more severe disability, as well as current distress and disability17. A threshold score of 13 has been traditionally used in previous studies14,18. A score of 13 was defined as serious psychological distress. Additionally, a score of 4 was defined as no or low psychological distress.

The Japanese version of the Patient Health Questionnaire-9 (PHQ-9)19 was used to assess depression. Participants reported depressive symptoms for the past 4 weeks on a scale of 0 (not at all) to 3 (almost daily)20.

A cutoff score of 10 or higher, as recommended by previous research, indicates a high probability of major depression19. The PHQ-9 has been used internationally as a screening scale for depression21, with high reliability and validity19.

Loneliness was measured using the Japanese version of the UCLA Loneliness Scale version 3 (UCLA-LS3)22, consisting of 10 items ranging from 1 (never) to 4 (always). The total score ranged from 10 to 40, with higher scores indicating greater loneliness23. The UCLA-LS3 has high reliability and validity and is used internationally as a scale to measure loneliness24,25,26.

Social networks were assessed by using the Japanese version of the Lubben Social Network Scale (LSNS-6)27. The LSNS-6 is a shortened version of the Lubben Social Network Scale28, and it includes items on the network size of relatives and friends who provide emotional and instrumental support. The LSNS-6 consists of three items related to family networks and three items related to friendship networks. The number of people in the network was calculated on a 6-point scale (0=none; 1=1 person; 2=2 persons; 3=34 persons; 4=58 persons; 5=9 or more persons) for each item29. Total scores ranged from 0 to 30, with higher scores indicating greater social networks and scores below 12 indicating social isolation.

Subjective happiness was assessed using the Japanese version of the Subjective Happiness Scale (SHS)30, a 4-item global subjective happiness scale. The response format is a 7-point Likert scale. One composite score is computed by averaging the responses to the four items, according to the reverse coding of the fourth item. The scores range from 1 to 7, with higher scores indicating greater well-being31.

The Japanese version of the Somatic Symptom Scale-8 (SSS-8) was used to assess the burden of physical symptoms32. The SSS-8 consists of eight items that assess the following physical symptoms: stomach or bowel problems; back pain; pain in the arms, legs, or joints; headache; chest pain or shortness of breath; dizziness; fatigue or low energy; and sleep disturbances. These items comprise four symptom domains: gastrointestinal, pain, cardiopulmonary, and fatigue. Participants reported the extent to which each symptom had bothered them in the past 7 days on a scale of 0 to 4 (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much)33.

Alcohol use was assessed using the Japanese version of the Alcohol Use Disorders Identification Test (AUDIT)34. As the AUDIT identifies the presence or absence of alcohol-related problems based on the past one year of alcohol use, the adoption of the AUDIT in a survey conducted every other year is optimal. The test consists of 10 items across three domains: hazardous alcohol use, dependent symptoms, and harmful alcohol use (three, three, and four items, respectively). Each item is scored on a scale of 0 to 4. The lowest AUDIT score was 0, and the highest score was 40. Higher scores indicated a higher likelihood and severity of hazardous drinking, harmful drinking, and alcohol dependence. Based on the WHO AUDIT cutoff criteria and the Japanese Ministry of Health, Labour and Welfare health guidance35,36, scores of 814 and 15 or higher were categorized into the hazardous drinking group and potential alcohol dependence group, respectively. Participants who scored 7 or less were placed in the no alcohol problem group.

With extensive reference to the literature on the COVID-19 pandemic9,10,12,37,38, we developed eight lifestyle and coping behavior items, and seven stressors were assumed to be associated with the COVID-19 pandemic (refer to Yamamoto et al.39). We asked participants to rate the frequency of implementation and their experience of these items from the start of the state of emergency (Phases 1 and 2) or the last 30 days (Phase 3), to the time of the survey, on a scale of 1 (not at all) to 7 (extremely). The details of these items have been described in our previously published articles.

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A 2-year longitudinal study examining the change in psychosocial factors under the COVID-19 pandemic in Japan ... - Nature.com

Study population

The prospective observational and cohort study was performed including two groups of patients with ESRD undergoing replacement therapy with hemodialysis (HD) from two different Nephrology Units of the Southern and Norther Italy. The first group of 16 HD patients was enrolled at the Nephrology Dialysis and Transplantation Unit of the University Hospital "Ospedali Riuniti", Foggia (Italy) and was used as main cohort (Testing Group). The second group of 36 HD patients was enrolled at the Nephrology Dialysis and Transplantation Unit of the University of Eastern Piedmont Amedeo Avogadro, Novara (Italy) and was used to validate the results obtained in the testing group of patients (Validation Group).

All the enrolled patients were>18 and<80years old and COVID-19 nave. Exclusion criteria were: therapy with immunosuppressive drugs, previous kidney transplant, systemic infections, cancer, HIV positivity or other life-threatening conditions with life expectancy lower than 6months.

This study aimed to compare the immunomodulatory effects of adsorptive dialytic treatments (Poly-methyl-methacrylate or PMMA-based) on COVID vaccine response compared to conventional Polysulphone-based dialytic treatments. Nevertheless, a limited number of patient chronically treated with PMMA membranes entering the inclusion criteria were followed at two different Nephrology Units involved in the study (26 HD patients). For this reason, a propensity-score matching analysis was conducted in R using the MatchIt package with nearest-neighbor 1-to-1 matching to compare HD patients treated with PMMA with HD patients treated with conventional dialytic membrane (Polysulfone).

All the enrolled patients were treated thrice a week with hemodialysis (HD) treatment for at least 12months. Both in the Testing Group [TG] and in the Validation Group [VG], half of the patients were treated with maintenance PMMA-based HD (AdsorptiveAdsorptive HD or AHD; n=8 for [TG] and n=18 for [VG], respectively) and the remaining with maintenance conventional HD with Polysulphone (PS) (Standard HD or SHD; n=8 for [TG] and n=18 for [VG], respectively).

Low-molecular weight or unfractionated heparin was administered as standard anti-coagulation therapy. Dialysis prescription was guided aiming at a value of urea reduction rate0.65 and a Kt/V1.2. The above parameters of dialysis adequacy were calculated according to the second-generation Daugirdas equation31.

To rule out the possibility of active or previous SARS-CoV-2 infection, all the patients of both groups were assessed for both PCR nasal swab and detection of anti-SARS-CoV-2 IgM and IgG, both resulted negative, and were therefore considered as SARS-CoV-2 nave.

The two study groups were enrolled from each separate hospital. Several meetings before the study initiation were made to confirm the absence of difference on dialysis condition (water quality or COVID19 infection status) between the two dialytic centers.

After signing an informed consent to participate to the present study, all the enrolled patients received two doses of the anti-SARS-CoV-2 mRNA BNT16b2 Vaccine (Comirnaty, Pfizer-Biontech, USA). All the clinical data at enrolment were collected and recorded.

The study protocol conformed to the ethical guidelines of the Declaration of Helsinki and was approved by the institutional review board (Decision no. 1570/2021 of 04 April 2021; Ethical Committee at the University Hospital "Policlinico Riuniti" of Foggia). This was in accordance with the guidelines laid down by the Regional Ethics Committee on human experimentation.

In all the enrolled subjects of both the groups, serum samples were collected before vaccination (Time 0, T0) and fourteen days after the second vaccine dose (Time 2, T2) and stored at 30C, until analyzed.

Only in the enrolled subjects of the Testing Group, whole blood (25ml) was collected from all patients at T0 and T2, as previously described32. Peripheral blood mononuclear cells (PBMCs) were isolated by density separation on SepMateTM (STEMCELL Technologies, Vancouver, Canada), according to manufacturers instructions, and stored at 80C, until analyzed.

Anti-SARS-CoV-2 Ig were titrated in both Testing Group and Validation Group two week after the second dose of vaccine with different methods, according to the local laboratory protocols.

In detail, as previously described32, anti-SARS-CoV-2 IgG and IgM titre in the Testing Group was analyzed by using a chemiluminescent analytical assay (CLIA) commercially available kit (New Industries Biomedical Engineering Co., Ltd [Snibe], Shenzhen, China), according to the manufacturer instructions. Reagent wells were coated with recombinant structural protein CoV-S (spike) and e CoV-N (nucleocapside) of SARS-CoV-2 for both IgM and IgG assay. For IgM assay, the microspheres were coated with a monoclonal antibody to capture human IgM followed by the addition of recombinant antigen from virus 2019-nCoV marked with amino-butylethyl-isoluminol (ABEI). The samples, serum or plasma, were diluted by instrument. The relative light units (RLU) detected was proportional to the concentration of IgG/M in sample. An RLU-ratio of the measurement of each sample to the supplied calibrator was calculated. According to manufacturer instructions, IgG assay BAU/mL of<1 was considered negative, 1.01.1 borderline and>1.1 positive; for IgM, an BAU/mL<0.9 was considered negative, 0.9 to 1.0 borderline and>1.0 positive. Clinical sensitivity was estimated by the manufacturer as 78.65% and 91.21% for IgM and IgG, respectively, while specificity was estimated as 97.50% and 97.3% for IgM and IgG, respectively.

Anti-SARS-CoV-2 IgG titre in the Validation Group was analyzed with a quantitative method for detection of IgG antibodies against the S1-RBD antigen (Atellica IM SARS-CoV-2 IgG [sCOV2G], Siemens Healthineers, Erlangen, Germany). This test is a fully automated, 2-step sandwich immunoassay, with indirect chemiluminescent technology. The patient specimen is incubated with preformed complex of streptavidin-coated particles and biotinylated SARS-CoV-2 recombinant antigens. The antibody-antigen complex is detected by an acridinium esterlabeled antihuman IgG mouse mAb. According to manufacturer instruction, IgG assay>1.00 was considered positive. Clinical sensitivity for IgG was estimated by the manufacturer as 96.41%, while specificity was estimated as 99.90%.

Only in the enrolled subjects of the Testing Group, serum neutralizing antibodies (NAb) levels were assayed, using a commercially available ELISA Kit, according to the manufacturers instructions (SARS-CoV-2 NeutraLISA, EUROIMMUN Medizinische Labor diagnostika AG, Lbeck, Germany), as previously described32. This competitive semi-quantitative test allows to evaluate the ability of Nab to prevent the link between the S1/RBD domain and the ACE2 receptor. In detail, microplate was coated with recombinant S1/RBD domain of SARS-CoV-2. Sample and controls were diluted 1:5 in dilution buffer containing soluble ACE2 conjugated to biotin and incubated in the reaction wells. Both Nab and soluble ACE2 competed for the binding site on the antigen surface. The photometric measurement at 450nm yielded the results as a percentage of inhibition (%IH). According to manufacturer instructions, 20%IH was considered negative, 20 to 35%IH borderline and>35%IH positive.

Only in the enrolled subjects of the Testing Group, PBMCs isolated from patients were thawed, counted and stimulated with SARS-CoV-2 IGRA stimulation tube set (EUROIMMUN Medizinische Labor diagnostika AG, Lbeck, Germany), as previously described32.

In details, 1*106 PBMCs were resuspended in PBS/EDTA and dispensed in each of the three stimulation tubes for 20h: CoV-2 IGRA BLANK for the determination of the background concentration of IFNy; CoV-2 IGRA STIM containing a mitogen causing non-specific secretion of IFNy; CoV-2 IGRA TUBE containing SARS-CoV-2 S1 components for the determination of specific IFNy secretion. After stimulation, samples were centrifuged and the supernatants used for subsequent quantitative assay using IFNy ELISA, according to the manufacturer instructions (EUROIMMUN Medizinische Labor diagnostika AG, Lbeck, Germany). Reaction wells were coated with anti-IFNy monoclonal antibody. Samples and controls were diluted 1:5 in a diluent buffer, incubated and processed according to manufacturer instructions. For IFNy quantification a 4-parameters logistics was applied.

Statistical analysis was performed using SPSS 25.0 software (IBM Corp., Armonk, NY. Variable distribution was tested using KolmogorovSmirnov test. Serum parameters were compared between groups by Students t-test for unpaired data and MannWhitney U-test, as appropriate. Frequencies were compared among groups by F-Fisher or X2-test, as appropriate. Correlation between two variables was ascertained by Pearson or Spearmans correlation tests, as appropriate. All the data are reported as meanstandard deviation (SD), median and interquartile range (IQR), or as percentage frequency, unless otherwise specified. A p-value<0.05 was considered statistically significant.

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PMMA dialyzers modulate both humoral and cell-mediate immune response to anti-COVID-19 vaccine (BNT162b2) in ... - Nature.com

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Vital Signs as Predictors of Oxygen Requirements in COVID-19 Outpatients: The Development of a Streamlined Risk ... - Cureus

Northeast Ohio doctor who claimed COVID-19 vaccine makes you magnetic has her medical license reinstated

WKYC:Sharona Hoffman,theEdgarA. Hahn Professor of Law, explained howadoctor was able to get her medical license reinstated despite her false claims abouttheCOVID-19 vaccine. Thesuspension came not because ofthesubstance of what she said but because she didnt cooperate with an investigation, Hoffman said.

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Law's Sharona Hoffman explains how Northeast Ohio doctor was able to get her medical license reinstated following ... - The Daily | Case Western...

Combined with clinical data and contact tracing, wastewater-based epidemiology (WBE) enables monitoring of SARS-CoV-2 community transmission, elucidating the onset, decline, and re-emergence of the epidemic15. Compared to the general community wastewater, pediatric dental wastewater can provide a targeted sample of asymptomatic children. This study uniquely detected SARS-CoV-2 RNA in the dental wastewater. The detection of SARS-CoV-2 RNA in 17 samples coincided with COVID-19 emergence among children in Saitama Prefecture. A sample obtained at the end of February 2022 contained the Omicron variant of SARS-CoV-2. Thus, the wastewater of pediatric dental clinics can provide information regarding asymptomatic COVID-19 in children.

Unlike clinical COVID-19 specimens, wastewater samples contain viral RNA at low concentrations. Therefore, we used Ct values as a reference without considering the copy number16. To detect SARS-CoV-2, we used the N1 and N2 primers and the probe set developed by the US Centers for Disease Control and Prevention (CDC), which amplify two regions of the nucleocapsid (N) gene17. In the kit used in this study, CDC N1 and N2 are modified using Cy5 and subjected to PCR in the same tube, thereby doubling the fluorescence intensity and improving assay sensitivity.

In Japan, the age-dependent epidemiological characteristics of COVID-19 varied among epidemic waves18. The sixth wave (Omicron variant) differed significantly from previous waves. The proportion of SARS-CoV-2 infections in individuals aged>70years was highest during the first wave (variant B.1.1)19, with the number of elderly cases gradually decreasing. The number of cases in 2050-year-olds markedly increased in the second to fifth waves (variants B.1.1.284, B.1.1.214, Alpha, and Delta, respectively)18,19. During the sixth wave (Omicron variant)18, the number of cases in individuals aged<19years increased rapidly.

Regarding vaccination in Japan, the mRNA vaccines developed by Pfizer and Moderna were mainly used20. Vaccination using the Pfizer vaccine began in April 2021, while the Moderna vaccine was introduced in May 2021. Initially, the vaccines were available to the elderly, and later the age range for vaccination has been gradually expanded to 12years and older. Vaccination of children aged 511years started in February 2022. Individuals in the age groups that were not vaccinated may have accounted for the increased number of cases.

Reports from other countries have indicated a high prevalence of the Delta and Omicron variants (particularly the latter) among children, implying that the characteristics of each virus variant were the main determinants of the number of cases21,22,23. In this study of children aged<10years in Saitama Prefecture, we observed an indistinct fourth wave that did not fall under the definition of an epidemic wave18. During the fifth and sixth waves, the NWRNC/100,000 population similarly increased and decreased for both preschoolers and schoolers aged<10years (p<0.0001, Wilcoxon matched-pairs test).

Although this study did not detect SARS-CoV-2 RNA during the period of Alpha-variant dominance, detection began in the same week as that of the fifth wave. Meanwhile, the sixth wave began 5weeks before SARS-CoV-2 RNA detection. We think that the SARS-CoV-2 RNA detection resulted from asymptomatic patients visiting the hospital. Generally, SARS-CoV-2 excretion begins 2days before symptom onset and persists for 710days. The incubation period is 1.5days longer in children than in the elderly24, while it is about one day longer for the Delta variant (4.41days; 95% CI, 3.765.05) than for the Omicron variant (3.42days; 95% CI, 2.883.96)24. The prolonged incubation period of the Delta variant could have increased the number of hospital visits by asymptomatic patients. Conversely, a significantly greater number of children were affected by the Omicron variant, including those with asymptomatic infections, compared to the Delta variant, and it is estimated that the number of asymptomatic children was much greater during the Omicron-predominant period than during the Delta-predominant period.

In Japan, COVID-19 vaccination began in April 2021. The vaccination coverage rate (two doses) was approximately 20% during the fifth wave and reached around 75% by December 2021, with over 70% in 1219-year-olds20. While no vaccine was available for children aged<12years at the time, the high community vaccination coverage rates could have contributed to the 5-week delay in SARS-CoV-2 RNA detection following the start of the sixth epidemic wave (Fig.2). The markedly increased NWRNC during the first 5weeks of the sixth wave may have been associated with increased number of asymptomatic patients visiting the clinic.

Vaccine coverage rate (the 2nd shot, %)27, detection period of SARS-CoV-2 RNA in wastewater from a pediatric dental clinic, and cumulative number of weekly reported new cases (NWRNC) per 100,000 population aged under 10years in Saitama Prefecture, Japan. The SARS-CoV-2 RNA detection period was observed in Weeks 2942 of 2021 (the fifth wave, Delta VOC predominant) and Weeks 821 of 2022 (the sixth wave, Omicron VOC predominant).

In this study, SARS-CoV-2 RNA was detected in wastewater until 3weeks after the end of the fifth wave, representing a period of high risk in terms of asymptomatic patients visiting the hospital, since COVID-19 infections in children are typically mild or asymptomatic. Additionally, the viral RNA can be detected for 1014days after symptom resolution. The number of days required to achieve PCR negativity has been reported to be similar between the Delta and Omicron (BA.1) variants25. Long COVID-19 was recognized by the WHO in 202126 and may account for the prolonged period of detection after the fifth wave.

The Omicron variant was detected simultaneously with the initial detection of SARS-CoV-2 RNA during the sixth wave, probably representing the peak of RNA release in this epidemic period. Despite a rapid decline of NWRNC following the peak of the sixth wave, SARS-CoV-2 RNA continued to be detected until the end of the survey period.

In WBE studies, SARS-CoV-2 RNA detection is generally considered a leading indicator of an increase in COVID-19 cases. However, in this study, the Delta and Omicron waves (Weeks 2939 of 2021 and Weeks 321 of 2022, respectively) preceded SARS-CoV-2 RNA detection in dental wastewater (Weeks 2942 of 2021 and Weeks 821 of 2022, respectively). Asymptomatic patients may have visited the clinic as the number of local cases increased. The increase in the number of cases was marginal during the fourth wave (Alpha variant), and SARS-CoV-2 RNA was not detected in wastewater from the pediatric dental clinic. This implies that a threshold number of cases is necessary for SARS-CoV-2 RNA detection in dental wastewater. Receiver operating characteristic (ROC) analysis was used to estimate the cut-off NWRNC/100,000 population value.

The cut-off and risk analysis demonstrated a strong association between SARS-CoV-2 RNA detection in dental wastewater and the NWRNC/100,000 population. The RR, 95% CI, and Fishers exact test results were identical among the three groups (RR, 5.36 [95% CI, 1.7216.67]; Fishers exact test, p=0.0005), although the cut-off values differed among the age groups.

During the SARS-CoV-2 RNA detection period, asymptomatic patients may have undergone dental treatment and been in contact with others in the preschool, school, or home settings. For all age groups, the RR was higher in the SARS-CoV-2 RNA detection period compared to that in SARS-CoV-2 RNA detection. Therefore, physicians and public health managers should be aware of the possibility of asymptomatic COVID-19 children when the NWRNC/100,000 population for those aged<10years reaches12.8 (preschoolers,13.4; schoolers aged<10years,20.2).

SARS-CoV-2 RNA positivity began when the NWRNC among children aged<10years reached12.8/100,000 population (RR, 7.8 [95% CI, 2.6323.21]; Fishers exact test, p<0.0001). A sample obtained in Week 8 of 2022 was found to harbor the Omicron VOC. This method may also be used to detect other viral pathogens in dental wastewater.

This study had several limitations. Since the data were all from Saitama Prefecture, the findings may not be generalizable to other locations. Therefore, further multicenter studies, using our study as a guide, are needed. Because wastewater samples contain viral RNA at low concentrations, a more comprehensive analysis could be conducted by improving the sensitivity of the assay. Additionally, multivariate analyses are required to overcome the effects of potential confounding factors and bias. To this end, efforts to gather more data for multivariate models, conduct several multicenter studies, and sensitivity improvement trials are currently underway.

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SARS-CoV-2 detection in pediatric dental clinic wastewater reflects the number of local COVID-19 cases in children ... - Nature.com

Published May 28, 2024 at 5:29 PM

Although COVID-19 may no longer dominate headlines, the pandemic is far from over. A new variant, known as FLiRT, is now responsible for the majority of COVID-19 infections across the United States, according to health officials. The FLiRT variant has been linked to a recent uptick in cases and hospitalizations in various regions. Health experts are urging the public to remain vigilant, emphasizing that this is not the time to let down their guard.

Ediz Tiyansan reports from Los Angeles.

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COVID-19 FLiRT wave takes over - CGTN America

Summer in California has an uninvited guest tagging along a set of COVID-19 subvariants being referred to as FLiRT.

Health officials in Sonoma and Napa counties are monitoring COVID-19 subvariants through wastewater. Recent data shows fairly low levels, those officials say.

Heres what you need to know.

FLiRT refers to predominant circulating subvariants of the strain JN.1 (including those known by the letters KP) and subvariants of Omicron, Sonoma County Health Officer Dr. Tanya Phares said in an email.

We know the FLiRT variants have two mutations on their spike proteins that werent seen on JN.1 (the previously dominant strain in the U.S.), Phares said. This makes these variants more transmissible and may make it easier for the virus to evade peoples immunity. Despite increased transmissibility, these mutations dont appear to result in more severe disease.

Sonoma County has sequenced eight cases of FLiRT subvariants from samples collected between March 22 and May 11, Phares said in her email.

Between April 1 and May 28 sampling showed JN.1 as the predominant variant, circulating at 21%, JN.1.4.3 circulating at 12.5% and KP.3 circulating at 7%, Phares said.

In Napa County wastewater detection of SARS-CoV-2 showed a slight increase since a low at the start of May, Public Health Director and Health Officer Dr. Christine Wu said in an email.

Napa County has not received any reports of the new COVID subvariant KP.2, Wu said.

From April 1 to today, the most prevalent subvariants were KP.2 at 7%, KP.3 at 4% and KP.1.1 at 3%

Statewide the most predominant circulating variant was JN.1, JN.1.7 and JN.1.4 from April 1 to today. But in May KP.2 and KP.3 became two of the top three most predominant strains circulating in California, Phares said.

County health officials are encouraging the public to follow standard guidance including staying up to date on vaccinations, hand washing and masking.

Regarding how to stay healthy, the CDC guidance has not changed, said Wu. If you feel sick, it may be best still to get a COVID test to know how best to treat yourself or adjust your plans, especially if you are going to spend time with family or friends who are at higher risk of severe illness.

Phares said vaccination was a key strategy to prevent against severe illness and death from COVID-19.

Paxlovid, the primary treatment for most people with COVID-19, should still work against these new variants, Phares said. Prevention efforts such as masking, hand washing, and improved ventilation can also help prevent against the spread of disease.

You can reach Staff Writer Emma Murphy at 707-521-5228 or emma.murphy@pressdemocrat.com. On Twitter @MurphReports.

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New COVID subvariants are circulating in Sonoma and Napa counties. Here's what we know - The Santa Rosa Press Democrat

People randomized to the Janus kinase (JAK) inhibitor baricitinib (Olumiant) to treat COVID-19 pneumonia in a clinical trial only saw a survival benefit if they had obesity, a post-hoc analysis found.

Death within 28 days of starting treatment occurred in 5.6% of patients with body mass index (BMI) values >30, compared with 9.2% of those assigned to placebo, according to Dennis G. McGonagle, MBBCh, PhD, of the University of Leeds in England, and colleagues.

That translated to an age-adjusted rate ratio of 0.6 (P<0.05), the group reported in RMD Open. A similar gap was seen in overweight patients (BMI 25 and 30).

In contrast, the same comparison made in patients with BMI <25 yielded survival rates of 6.6% with baricitinib versus 8.1% in the placebo group, which missed the P<0.05 threshold. The nonsignificance was not easily attributable to small sample size, as there were 120 and 132 patients with normal-range BMI assigned to baricitinib and placebo, respectively, and a total of 26 deaths among them.

The new findings come from an age- and BMI-stratified analysis of data from the multinational COV-BARRIER trial, conducted early in the pandemic, in which a total of 1,525 patients with COVID-19 pneumonia needing oxygen support were randomized to baricitinib or placebo on top of standard treatments including antivirals and/or corticosteroids. (Primary results were published here in 2021.) Approximately 17% of each arm were in the normal BMI range; roughly 40% were overweight and the remainder had obesity.

Overall, 162 patients died within 28 days, although seven of these were excluded from the analysis because data on BMI and age were missing. Most of the deaths occurred in patients 65 and older, who represented 30% of the total sample.

The investigators had no solid explanation for how excess body fat could make baricitinib more effective in COVID-19 pneumonia. In previous studies, COVID-19, obesity, and JAK inhibition all appeared to promote thrombosis, such that baricitinib ought to worsen, not improve, survival in COVID patients with overweight/obesity. Responses to JAK inhibitors in rheumatologic diseases have, indeed, been found to be worse among individuals with obesity.

"[O]ur findings are remarkable and suggest a hitherto unappreciated mechanism for this 'JAK thrombosis-related paradox,'" McGonagle and colleagues wrote. The group suggested that coagulability and thrombosis associated with obesity are key factors: "[T]his population has poorer tissue oxygenation and suffers more from COVID-19 immunothrombosis that is controlled when treated with baricitinib and standard COVID-19 therapy," they noted. In particular, the researchers argued that the use of corticosteroids alongside baricitinib may account for the "counterintuitive" results.

John Gever was Managing Editor from 2014 to 2021; he is now a regular contributor.

Disclosures

COV-BARRIER was funded by Eli Lilly but the company was not involved in the post-hoc analysis except to provide the data. Authors declared they had no relevant financial interests.

Primary Source

RMD Open

Source Reference: David P, et al "Pronounced benefits of JAK inhibition with baricitinib in COVID-19 pneumonia in obese but not lean subjects" RMD Open 2024; DOI: 10.1136/rmdopen-2023-004045.

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Not All COVID Patients Benefit From JAK Inhibitor - Medpage Today

The bacterial disease salmon rickettsial syndrome (SRS) has been a major impediment toward the Chilean salmon-farming industry's achievement of its pledge to reduce its antibiotic usage 50 percent by 2025.

Through the Yelcho Project, which was launched in March 2024as part of a larger collaboration to push for a reduction in the industrys use of antibiotics, the industry is seeking to apply lessons from Chile's highly successful Covid-19 approach in its efforts to tackle SRS. Just two years after Chile began its vaccinations against Covid-19, about 92 percent of the country's population had been administered at least one dose, far outpacing all of its neighbors and many countries worldwide, due in large part to an approach by the government to obtain as many vaccine doses as possible. It diversified its agreements with potential suppliers, while academic institutions ensured doses by partnering with laboratories to perform clinical trials in the country.

The Yelcho Project has turned toward David Farcas, an expert in animal health after decades of leading veterinary health firm Centrovet. During the Covid-19 crisis, he chaired the Science and Technology Ministrys Committee of Scientific Advisors that led the evaluation of Covid-19 vaccines and coordinated Phase 3 trials of the vaccines in Chile. In an interview with SeafoodSource, Farcas and Daniel Woywood, the technical manager at Yelcho Project partner Aquabench, discussed how lessons learned from the Covid pandemic can be translated to the salmon industry.

SeafoodSource: David, you worked on Chiles campaign against Covid-19. What parallels can you draw between your work with Covid-19 and your work now with the Yelcho Project?

Farcas: Id say the focus and the need to come up with very practical solutions in a very short period of time is one. Second, this is very pragmatic and not political. What we did during Covid was team up with pharmaceutical companies that had Covid prototypes, providing them the right incentives in order for us to be first in line when it came time to distribution. We offered to team up with them during the development stage of the vaccine in Phase 3 trials. We didnt have the pharmaceutical capability, but we had a sensible way of testing the vaccine efficacy and safety in our population.

By having an early commitment with the pharmaceutical companies, we ended up being their partners, so when the vaccines were available, they came to us first. The parallel is the pragmatism, the commitments, and collaboration. For Covid, we were able to use the power of the state to have first priority in making alliances with pharmaceutical companies at the CEO level for acquiring the vaccine, and the universities were in charge of testing; the state also was in charge of the regulation and delivery. That was our inspiration for the Yelcho Project.

SeafoodSource: How did the Yelcho Project come about?

Farcas: I had a role in a pharmaceutical company [Centrovet] for years. We sold this company to a French conglomerate [Virbac] a few years ago, so I was unemployed and devoted my time to Covid for a year and a half. When Covid ended, just by coincidence, three of the salmon farmers called me and said, We have an issue with SRS. We have a fantastic product, producing the best protein in the world, but we have a challenge in reducing antibiotics use. Why dont you come up with a proposal for us to solve it? Three different general managers asked me this on different occasions.

It was clear we have an opportunity here, and for me personally, it was a way to give back to this fantastic industry. I found the task quite challenging, but if you look at the commitment they showed, holding the conversations with an open mind, it was clear that all the stars were aligned for this project to start.

Aquabench was available from day one to help in the organization and coordination of the project, so we ended up having a fantastic team, formed by us, Aquabench, and one company CEO comprising the managing team. Then, there is a bigger team composed of company managers or owners, SAG [the Chilean Agricultural and Livestock Service], and Sernapesca [Chiles national fisheries and aquaculture service]. Were working in a very pragmatic way.

It took us a bit longer than expected about a year to organize and do the kick-off because companies did not want to do anything before it was clear that we would be able to come up with something. They wanted to play it safe.

SeafoodSource: Does that mean increasing vaccinations as a preventative measure?

Woywood: It means increasing the efficacy of the vaccines and improving the vaccination strategy. In terms of vaccine efficacy, the last vaccine introduced to the market was developed over 10 years ago. So, its an old vaccine, especially if you compare it to Covid. There are new vaccine technologies as well, which improve the efficacy.

On the other hand, you can improve the vaccination strategy. For example, you can carry out two vaccinations in the freshwater stage, or you can do a booster in saltwater during the grow-out stage.

SeafoodSource: Daniel, you come from Aquabench, while David is a member of the board at Benchmark Genetics. Is Benchmark participating in this initiative as well?

Farcas: Benchmark places a big emphasis on SRS reduction, but that comes from the genetics side. This is a pharmaceutical, immunological initiative; the focus is on vaccines.

I was on the original team that introduced the Pincoy Project, led by Skretting, which was focused on best practices. There are different focuses now with Yelcho. You have the CEOs of participating companies committing to solutions. This is a hierarchical company decision where we can contribute in a very important way.

SeafoodSource: The project aims for a significant reduction in antibiotics use. Is there a specific percentage or timeline?

Farcas: We have decided not to ...

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How Chile is taking lessons learned from its Covid-19 response to address antibiotic use in salmon farming - SeafoodSource

This research provide a comprehensive examination of the impact of clinical, demographic, and lipid-related factors on the severity and mortality of patients with COVID-19. The findings presented in our study indicate that there are no statistically significant differences between critical and non-critical cases when considering gender. Nevertheless, it is worth noting that there was a discernible pattern linked to age, as older people were overrepresented among patients who experienced severe outcomes or did not survive. These data provide support for the widely accepted scientific consensus that age is a significant risk factor for negative outcomes related to COVID-19, such as hospitalization, admission to critical care units, and death33.

The substantial proportion of the cohort with diabetes and hypertension in this study is consistent with previous research indicating that these comorbidities are associated with worse outcomes in COVID-1934. These conditions are known to exacerbate the inflammatory response and contribute to endothelial dysfunction, which may enhance the severity of SARS-CoV-2 infection. This suggest that COVID-19 patients with comorbidities like diabetes and hypertension may be at higher risk of disease severity and mortality35. Therefore, it is significant to identify and manage these comorbidities in COVID-19 patients to improve their outcomes.

However, variables including sex, diabetes, and obesity, were not significantly associated with survival outcomes. Previous studies have identified these as potential risk factors for severe COVID-19 outcomes36,37, which is unexpected. The absence of an association in the present study may be attributable to the small sample size, necessitating additional research in larger cohorts.

When comparingthe lipid profiles of COVID-19 patientsbetween severity and survival outcome groups, no significant differences in cholesterol levels across severity or outcome groups in COVID-19 patients. The median cholesterol levels were comparable across all groups, with non-critical patients exhibiting slightly higher levels than critical patients. Similarly, the study found no significant differences in high-density lipoprotein cholesterol (HDL-c) levels among severity and outcome groups. The values were closely matched in all groups, with non-critical patients and survivors marginally higher than their counterparts. The study found slightly lower median values of low-density lipoprotein cholesterol (LDL-c) in critical compared to non-critical patients, but this difference was insignificant. This finding is consistent with a study by Zhang et al. that found that LDL-c levels were lower in COVID-19 patients with severe disease than those with mild disease8.

Triglyceride levels showed a statistically significant difference between survival outcome groups, with non-survivors exhibiting higher median levels. This suggests a potential association between elevated triglycerides, reduced HDL-c levels, and increased mortality risk in COVID-19 patients. According to additional studies, high triglyceride levels and low HDL-c levels are predictors of COVID-19 severity and mortality6,10,19,38. Nevertheless, the relationship between lipid profiles and COVID-19 outcomes is not yet fully understood, and additional research is required to identify the precise mechanisms underlying this association. According to the lipid profile changes, elevated triglycerides are associated with COVID-19 severity and mortality; this finding is consistent with a recent meta-analysis that linked elevated triglycerides to COVID-19 severity and mortality10.

Similarly, Masana et al.19 identified low HDL cholesterol and elevated triglycerides as predictors of COVID-19severity. However, the conclusions drawn from previous studies regarding the alterations in serum lipids in COVID-19 patients are inconsistent. For instance, Liu et al. found that dyslipidemia was not associated with COVID-19 severity or mortality39. Different study designs, patient populations, and lipid profile measurements may account for these discrepancies.

The present study also evaluated the ability of lipid profile variables to predict COVID-19 severity and mortality using AUC-ROC curves. The study found that all lipid profile components had moderate discriminatory ability, with AUC values ranging from 0.79 to 0.89. The study also established optimal cut-off points for each lipid variable based on the Youden's index J and found that each lipid variable, except for Tryg, showed a significant association with mortality outcome in logistic regression analysis. The multivariate logistic regression model revealed that the lipid variables had substantial predictive value for severity and mortality outcome, even after adjusting for potential confounders such as age, sex, diabetes, hypertension, and obesity.

These findings are consistent with previous research showing that lipid profile alterations are associated with COVID-19 severity and mortality40. Moreover, the present study's findings suggest that lipid profile variables may be useful in predicting COVID-19 outcomes and could be used as a readily available biological marker to predict the severity and mortality of COVID-19 infection41. However, it is essential to note that lipid profile variables are just one of many factors that may influence COVID-19 outcomes. Other factors, such as treatment adherence on chronic diseases42, albumin levels43, Leukocyte glucose index44, and neutrophillymphocyte ratio41, have also been identified as predictors of COVID-19 outcomes.

Other research indicates that comorbidities may moderate the relationship between lipid profile and COVID-19 outcomes. For instance, Kumari et al.45 found that lipid profiles may be a potential marker for determining the disease prognosis for COVID-19 patients, but they did not examine the impact of comorbidities. The precise mechanisms coupling these comorbidities to worse outcomes are not fully understood, but they could involve a combination of factors, such as chronic inflammation, impaired immune function, and increased susceptibility to viral entry and replication.

In addition, the findings of the presented study may have substantial implications for the treatment of COVID-19 patients. Age and hypertension were identified as significant survival predictors in COVID-19 patients, particularly in the context of early identification and management of comorbidities. Findings regarding triglycerides suggest that surveillance and treatment of lipid profile abnormalities may be necessary for enhancing COVID-19 outcomes. In addition, further research is necessary to thoroughly comprehend the mechanisms underlying the association between COVID-19 and lipid profile levels and to develop effective interventions for preventing and treating dyslipidemia caused by COVID-19. Furthermore, this study emphasizes the significance of considering comorbidities such as diabetes and hypertension when assessing the severity and mortality of COVID-19. Age and hypertension were significant survival predictors in both univariate and multivariate Cox proportional hazards regression models. Additionally, the survival analysis for HDL-c levels also revealed interesting findings.

The present study found that COVID-19 patients with higher HDL-c levels may have a greater chance of survival. This finding aligns with previous research suggesting that HDL-c, known for its anti-inflammatory and antioxidant properties, may have a protective role in COVID-19. In this sense, some studies evaluated the HDL-c anti-inflammatory and antioxidant activity, proving that the Serum amyloid A (SAA), Apolipoprotein A-1, Alpha-1 antitrypsin, and paraoxonase 1 (PON-1) (HDL-c associated proteins) are altered in SARS-CoV-2 infection which could be related to decreased functionality of HDL-c in COVID-19 severity23,46.

Moreover, evidence suggests that cholesterol-rich lipid rafts and receptors, such as HDL scavenger receptor B type 1 (SR-B1), which regulate lipid entry into cells can enhance SARS-CoV-2 entry17. HDL-c mobilizes the cholesterol of cholesterol-rich lipid rafts for traffic and re-localizes SARS-CoV-2 receptors, which promote the viral entry into cells17.Because HDL-c has immunomodulatory effects, it could be hypothesized that low HDL-c levels during infection are associated with the regulation of immune cells in COVID-19 severity47,48. A study evaluating lymphocytes, macrophage activation, dendritic cells, inflammatory mediators, cytokines, and their correlation with HDL-c levels during SARS-CoV-2 infection is required to test this hypothesis.

Stadler et al. demonstrated that the cholesterol efflux capacity is associated with mortality, ApoA-I protein, HDL-ApoA-I protein, HDL-c, total ApoA-II protein, HDL-free cholesterol, and HDL phospholipids in patients with COVID-1949. Another study demonstrating the importance of HDL-c during SARS-CoV-2 infection showed that a ratio of triglyceride to HDL-c was related to the risk of severe COVID-1950.

Changes in lipid profile levels could have clinical applicability in providing timely treatment for patients with COVID-19. In this regard, a study of lipid profiletrajectories during the two years before COVID-19 testing revealed that higher antecedent HDL-c levels were associated with a lower SARS-CoV-2 infection risk. These levels, however, declined during viral infection51. On the other hand, Jin et al. reported that the patients infected during the first wave of COVID-19 with high levels of low-density lipoprotein cholesterol (LDL-c), triglyceride, and total cholesterol before infection and on admission had a poor progression of COVID-197. Moreover, HDL-c, LDL-c, total cholesterol, and triglyceride were significantly lower in the patients with COVID-19 during the first wave of COVID-19, demonstrating that lipid profile predicts the severity of SARS-CoV-2 infection52. Al-Zadjali et al. demonstrated that low HDL-c levels areassociated with increase long-term COVID-19 severity in unvaccinated patients infected with SARS-CoV-2 after the first wave of COVID-1953. Regarding vaccination, a study focused on analyzing the lipid profile before and after the two doses of the COVID-19 vaccination in patients without exposure to SARS-CoV-2 infection revealed that triglyceride levels were significantly decreased and cholesterol, HDL-c, and LDL-c levels were significantly increased in patients who received the mRNA-1273 (Moderna) vaccine54. Individuals vaccinated with the BNT162b2 (Pfizer-BioNTech) vaccine had a significant increase in HDL-c, while patients vaccinated with ChAdOx1 nCov-19 (Oxford-AstraZeneca) had no change in lipid profile after follow-up54. Szczerbiski et al. reported an absence of statistically significant correlation between the total cholesterol, HDL-c, and LDL-c levels and anti-SARS-CoV-2 S antibodies concentration at the end-of-observation-19 weeks in patients vaccinated with the second dose of BNT162b2 mRNA COVID-19 vaccine55. On the other hand, in the patients who received the COVID-19 vaccine and were diagnosed with SARS-CoV-2 infection after the first wave of COVID-19, the total cholesterol, HDL-c, and LDL-c were significantly lower in non-survivors and these values were associated with the mortality risk56. Furthermore, patients with low levels of LDL-c, total cholesterol, and anti-SARS-CoV-2 antibodies had the highest mortality rates56. Thus, lipid profile, emerging SARS-CoV-2 variants, and the immune response in COVID-19 vaccine recipients (neutralizing antibodies against SARS-CoV-2) could be strongly related with COVID-19 mortality through a pathophysiological mechanism where the statin therapy would improve the chances of survival57.

Despite the emergence of new SARS-CoV-2 variants, our findings remain clinically relevant, offering insights into the prognostic value of lipid profiles in COVID-19 patients. These insights are pivotal for risk stratification and the development of management strategies that are adaptable to the evolving pandemic landscape. Furthermore, this study elucidates the critical associations between lipid profile abnormalities and COVID-19 severity and mortality, thereby contributing significantly to existing literature. However, the study is not without limitations. The retrospective design, small sample size, and absence of control groups introduce potential biases and limit the generalizability of our findings. Additionally, uncontrolled confounding variables and population heterogeneity further constrain the study's applicability. Despite these constraints, this researchmakes a significant contribution to the field. Future investigations should adopt a prospective methodology, incorporate larger and more diverse cohorts, and include control groups. Employing advanced statistical techniques to control confounders and conducting mechanistic studies will refine our understanding and facilitate targeted interventions, thereby enhancing the study's global scientific impact.

Our findings suggest that patients with comorbidities should be classified with caution based on their lipid profile values when assessing the prognosis of COVID-19 patients. In addition, the relationship between lipid profile, disease outcome, and comorbidities must be understood to guide adequate risk stratification and treatment planning for COVID-19 patients. Similarly, the underlying mechanisms and potential interventions for dyslipidemia in COVID-19 patients require additional research. Despite its moderate AUC, the logistic regression model suggests a limited yet non-negligible ability to discriminate between patient outcomes based on lipid profiles. While the model exhibits high sensitivity, its specificity is notably low, indicating a propensity for false positive predictions, which could limit its clinical utility. In contrast, the Cox model's incorporation of time-to-event data provides a more granular analysis of risk factors, reinforcing the prognostic significance of age and hypertension. These results are consistent with existing literature that highlights the exacerbation of COVID-19 severity by underlying health conditions. Our findings corroborate previous studies that have identified age and hypertension as critical determinants of COVID-19 prognosis. However, the unique contribution of this study lies in its analytical approach, combining logistic regression with Cox proportional hazards modeling to enhance the depth of prognostic assessments. This study's primary limitations stem from its reliance on available clinical data, which may not capture all potential confounders. Future research should explore the inclusion of additional variables, such as genetic markers and patient lifestyle factors, which could further refine the predictive models presented herein. However, this study advances knowledge by shedding light on the prognostic significance of the lipid profile of COVID-19 infection. It also highlights the significance of considering lipid metabolism in treating and staging the disease.

When understanding the usefulness of lipid profiles in the prognosis of COVID-19, the classification of patients based on clinical guidelines or other clinical parameters should be considered. Our study classified the patients according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia, issued by the Chinese Centers for Disease Control and Prevention. Other studies that validated a clinical risk score or analyzed intermediates of cholesterol biosynthesis and their association with the clinical outcomes of SARS-CoV-2 infection classified the severity of COVID-19 based on the American Thoracic Society guidelines and the National Institutes of Health recommendations, respectively58,59. Hence, these and other classifications should be considered when comparing study results to avoid errors in interpreting severity and mortality predictors for COVID-19.

A comprehensive understanding of the effect of lipid profiles on COVID-19 outcomes may lead to improved clinical decision-making and patient care. In conclusion, this study advances our understanding of the factors influencing COVID-19 outcomes, emphasizing the role of systemic health issues such as hypertension. The dual analytical approach utilized herein not only highlights significant predictors but also underscores the complexity of prognostic modeling in infectious diseases.

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Association between lipid profile and clinical outcomes in COVID-19 patients | Scientific Reports - Nature.com