Determinants of post-acute COVID-19 syndrome among hospitalized severe COVID-19 patients: a 2-year follow-up study (preprint)

BackgroundCoronavirus disease-19 (COVID-19), emerged as a public health threat in December 2019. The number of COVID-19 cases worldwide is now more than 765 million with more than 6.9 million dead. During follow-up visits following discharge, a large percentage of patients were discovered to still be suffering from health issues that lower their quality of life and ability to return to work. This study assessed the prevalence and associated risk factors of post-acute COVID-19 syndrome (PACS) among severe COVID-19 patients who were discharged from Millennium COVID-19 care center, Addis Ababa, Ethiopia. MethodsA cross-sectional study using data collected from patient charts and a follow-up telephone interview after two years of discharge. Systematic random samplingwas used to select a total of 400 patients. A structured questionnaire developed from the case report form for PACS of WHO was used. Frequency and cross-tabulation were used for descriptive statistics. Predictor variables with a p-value <0.25 in bivariate analyses were included in the logistic regression. ResultOut of the 400 patients, 20 patients were dead, 14 patients refused to give consent, and 26 patients couldnt be reached because their phone wasnt working. Finally, 340 were included in the study. The majority (68.5%) were males and the mean age was 53.9 ({+/-}13.3 SD) years. Most of the patients (60%) has one or more comorbidity. The most common symptom at presentation was cough (93.5%), followed by shortness of breath (82.1%) and fatigue (69.7%). The mean duration of hospital admission was 12.3 ({+/-}6.5 SD) days. More than a third (38.1%) of the patients reported the persistence of at least one symptom after hospital discharge. The most common symptoms were fatigue (27.5%) and Cough (15.3%). older age (AOR 1.04, 95% CI 1.02 - 1.07), female sex (AOR 1.82, 95% CI 1.00 - 3.29), presence of comorbidity (AOR 2.38, 95% CI 1.35 - 4.19), alcohol use (AOR 3.05, 95% CI 1.49 - 6.26), fatigue at presentation (AOR 2.18, 95% CI 1.21 - 3.95), and longer hospital stay (AOR 1.06, 95% CI 1.02 - 1.10) were found to increase the odds of developing post-acute COVID-19 syndrome. Higher hemoglobin level was found to decrease the risk of subsequent post-acute COVID-19 syndrome (AOR 0.84, 95% CI 0.71 - 0.99). Conclusionestablishing a dedicated PACS follow-up clinic, especially for those with a higher risk can help to provide comprehensive care for the patients and improve their quality of life.

Vaccination saves lives: How do patients with chronic diseases and severe COVID-19 fare? Analysis from India’s National Clinical registry for COVID-19 (preprint)

Objectives This study aims to describe the demographic and clinical profile and ascertain the determinants of outcome among hospitalised COVID-19 adult patients enrolled in the National Clinical Registry for COVID-19 (NCRC). Methods NCRC is an on-going data collection platform operational in 42 hospitals across India. Data of hospitalized COVID-19 patients enrolled in NCRC between 1 st September 2020 to 26 th October 2021 were examined. Results Analysis of 29,509 hospitalised, adult COVID-19 patients [mean (SD) age: 51.1 (16.2) year; male: 18752 (63.6%)] showed that 15678 (53.1%) had at least one comorbidity. Among 25715 (87.1%) symptomatic patients, fever was the commonest symptom (72.3%) followed by shortness of breath (48.9%) and dry cough (45.5%). In-hospital mortality was 14.5% (n=3957). Adjusted odds of dying were significantly higher in age-group ≥60 years, males, with diabetes, chronic kidney diseases, chronic liver disease, malignancy, and tuberculosis, presenting with dyspnea and neurological symptoms. WHO ordinal scale 4 or above at admission carried the highest odds of dying [5.6 (95% CI: 4.6, 7.0)]. Patients receiving one [OR: 0.5 (95% CI: 0.4, 0.7)] or two doses of anti-SARS CoV-2 vaccine [OR: 0.4 (95% CI: 0.3, 0.7)] were protected from in-hospital mortality. Conclusions WHO ordinal scale at admission is the most important independent predictor for in-hospital death in COVID-19 patients. Anti-SARS-CoV2 vaccination provides significant protection against mortality.

Fear and Anxiety related to Covid-19 pandemic may predispose to perinatal depression (preprint)

Purpose: . The COVID-19 pandemic situation significantly affected the mental health of the general and clinical population including that of pregnant and puerperal women due to lack of access to healthcare, social isolation, sleep loss, feelings of fear and uncertainties. However, few studies investigated which COVID-19-related psychopathological determinants may predispose to perinatal depression. The aim of this study was to evaluate the impact of COVID-19 related anxiety and fear on perinatal depression . Methods: . We retrospectively screened 184 perinatal outpatients afferent to Perinatal Mental Health outpatient service, during March 2020-March 2021, by using the Edinburgh Postnatal Depression Scale (EPDS), the Fear of COVID-19 (FCV-19-S) and the Coronavirus Anxiety Scale (CAS). Results: . The mean EPDS score was 9.0 (SD=5.3), experiencing a clinically relevant perinatal depression in 45.7% of the sample. The mean FCV-19-S score was 15.0 (SD=6.2) and CAS was 1.7 (SD=2.8). Linear regression analyses demonstrated that FCV-19-S (F(1,68)=12.218, R 2 =0.152, p<0.001) and CAS scores (F(1,68)=10.278, R 2 =0.131, p=0.002) statistically significantly predicted EPDS total scores. A positive correlation was reported between FCV-19-S and EPDS (r=0.390, p<0.001) and between CAS and EPDS (r=0.362, p<0.001) . Conclusion: COVID-19 pandemic with its subsequent isolation, quarantine and lockdown might determine increased levels of anxiety and fear, particularly among women in their perinatal period who may experience a deprivation of their normal sources of family and social support and, hence, experience psychological distress, even in those women without a previous psychiatric history. Further preventive and screening strategies should be implemented in order to early identify at-risk pregnant and puerperal women during the COVID-19 pandemic.

A Novel Barrier Device and Method for Protection against Airborne Pathogens During Endotracheal Intubation (preprint)

ABSTRACT Background The risk of SARS-CoV-2 transmission to healthcare workers increases during aerosol-generating procedures such as endotracheal intubation. Objectives We tested the effectiveness of a novel barrier mouthpiece in reducing clinician exposure to aerosols and droplets during endotracheal intubation. Design A prospective case control study was carried out, with a single operator performing eight simulated intubations with and without the device on two different high-fidelity manikin models which produced aerosols and droplets. Setting The study was performed during June 2020, at the Clinical Skills Development Service, Brisbane, Australia. Interventions Simulated scenarios included 1) intubation during cardiopulmonary resuscitation 2) intubation while pre-oxygenating via high flow nasal cannula. Photographic images were obtained during each intubation and digitally analyzed using ImageJ v2.1.0/1.53c. Patients Not applicable. Main outcome measures Aerosol and droplets were quantified using pixel counts. Overall results were expressed as means (± SD), with comparisons between groups made using a two-tailed Student’s T-test under the assumption of unequal variances. A P value of ≤ 0.05 was considered as statistically significant. Results First pass intubation was achieved in all scenarios, with and without the barrier device. Pixel counts demonstrated significant overall reduction in aerosol and droplet exposure when the barrier device was used during intubation [Mean (SD) count:509 (860) vs 10169 (11600); P=0.014]. The highest exposure risk to airborne particles was observed during simulated induction, prior to laryngoscopy and intubation. Conclusions The novel barrier device was effective in reducing environmental exposure to aerosols and droplets during intubation without negatively affecting first pass intubation. The highest risk of exposure to airborne particles was during induction, before intubation takes place. Clinical trials are indicated to further test the feasibility and efficacy of this device. Trial registration Not applicable. KEY POINTS This prospective, preclinical study represents a pilot trial of a novel barrier mouthpiece for reducing clinician exposure to aerosols and droplets during endotracheal intubation. In eight simulated intubations with and without the barrier mouthpiece, the device proved effective in reducing environmental exposure to aerosols and droplets (measured in pixels) during intubation, without negatively affecting first pass intubation. The novel barrier mouthpiece represents a possible solution for reducing the risk of respiratory pathogen transmission during endotracheal intubation without hampering the procedure itself, although larger preclinical and clinical trials are necessary.

Distinct characteristics of the COVID-19 among children and young adolescents treated at Gulu Regional Referral Hospital; Northern Uganda: A cross-sectional study (preprint)

Background: Ever since the appearance of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease (COVID-19) in Wuhan in mid-December 2019, its spread has been dramatic worldwide. It became apparent that the number of pediatric COVID-19 patients was much lower than in adults. Variable clinical presentations and progression have characterized morbidity and mortality in children and young adults. Objective The objective of this study was to assess the characteristics of the COVID-19 among children and adolescents below 20 years in Northern Uganda and determine factors associated with treatment outcomes in the study population. Materials and Methods A cross-sectional study conducted a retrospective data abstraction of the COVID-19 patients registered in the Gulu Hospital Health Management Information System (HMIS) database and other tools. The study covered the period between March 2020 and October 2021. Data that met the inclusion criteria were consecutively extracted from the Gulu Hospital HMIS database. A local IRB approved the study. SPSS version 25.0 was used for data analysis, and a p-value less than 0.05 was considered significant. Results There were 41 COVID-19 patients below 20 years among the 664 total COVID-19 patient population, constituting 41/664(6.2%) of the total COVID-19 patients treated at Gulu Regional Referral Hospital from March 2020 to October 2021. The median age was 19 years (ranging from 13 to 20 years), the mean age was 18.2 years SD±1.95 at 95% CI:17.51-18.74. Females constituted 58.5% of the study population. The mean duration of hospital stay was 14.44 days SD±10.45 at 95% CI:11.14-17.74, and the mean duration of symptoms at admission was 7.96 days SD±7.38 at 95% CI:4.84-11.07. The comorbidities were cardiovascular diseases 3/41(7.3%) and hypertension 3/41(7.3%) and were not in the same patients. Pneumonia 1/41(3.3%) and acute liver injury 1/41(3.3%) were the observed complications. The morbidity and mortality rates were 2/41(4.9%) and 0/41(0.0%), respectively. Participants’ symptoms, signs, complications, and comorbidities by gender were not statistically significant. Conclusion Data showed excellent treatment outcomes of the COVID-19 among children and adolescents below 20 years in Northern Uganda with a recovery rate of 100.0%. The burden of symptoms of the illness, comorbidities, and complications was fewer. There is a need to conduct more extensive studies on the role played by age in the successful recovery of COVID-19 patients, even in a low-resource milieu.

Clinical Characteristics of Vulnerable Populations Hospitalized and Diagnosed with COVID‑19 during Second Wave in Buenos Aires, Argentina. (preprint)

There are a few in Argentina publications regarding the presentation of patients with COVID-19 requiring hospitalized and emergency care in vulnerable populations that compares the first and second wave, and it has few reports in developing countries. The objective is to determine whether in the care of vulnerable patients, to succeed against COVID-19, multiple public health tools and interventions necessary to minimize morbidity and mortality. The study is a prospective cohort investigation of 3028 patients during second wave with lab-confirmed COVID-19, who required any of the Health Centers response from April 1, 2021, to June 30, 2021. In a previous publication, our group analyzed the situation of hospitalized patients during the first wave in the same region, "Southeast Network" (SN), Buenos Aires Metropolitan Area (AMBA). SN with 1.8 million inhabitants residing in urban and rural areas. A total of 14 health centers with different levels of care complexity provide care to patients in the region. The information of each patient with COVID-19 evaluated by SN, was incorporated in an Epidemiological Dashboard. The investigation was designed and reported with consideration of observational studies in epidemiology. A total of 57.9% patients were men, and the mean age (SD) was 52.1 (13.5) years. Sixty four percent patients with pre-existing diseases, most frequent hypertension and diabetes, but diabetes, obesity, and cardiovascular disease presented higher risk. A total of 24.7% were hospitalized in Intensive Therapy Unit. The mortality of the cohort was 22.9%. Mortality was higher for patients aged 65 or more, and for those had some pre-existing disease. But, it was a slightly more than double that in the first wave, it is possible mainly due to the fact that more than doubled of patients in Second wave required hospitalization in ITU, compared to First wave. The patients presented greater severity of their medical condition at the time of their hospitalization. These findings were similar to those reported by other authors. Another possible cause of the high number of patients in the period studied is due to the fact that most of the hospitalized population had not been vaccinated. The health system was able to respond to the demand.

Long-haul COVID: Healthcare Utilization and Medical Expenditures 6 Months Post-diagnosis (preprint)

Background: Despite evidence that long-term COVID-19 symptoms may persist for up to a year, their implications for healthcare utilization and costs 6 months post-diagnosis remain unexplored. Methods Our objective is to determine for how many months post-diagnosis healthcare utilization and costs of COVID-19 patients persist above pre-diagnosis levels and explore response heterogeneity across age groups. This population-based retrospective cohort study followed COVID-19 patients’ healthcare utilization and costs from January 2019 through March 2021 using claims data provided by the COVID-19 Research Database. The patient population includes 328,777 individuals infected with COVID-19 during March-September 2020 and whose last recorded claim was not hospitalization with severe symptoms. We measure the monthly number and costs of total visits and by telemedicine, preventive, urgent care, emergency, immunization, cardiology, inpatient or surgical services and established patient or new patient visits. Results The mean (SD) total number of monthly visits and costs pre-diagnosis were .4805 (4.2035) and 130.67 (1,216.66) dollars compared with 1.1998 (8.5184) visits and 341.7576 (2,439.5581) dollars post-diagnosis. COVID-19 diagnosis associated with .7338 (95% CI, 0.7175 to 0.7500 visits; P < .001) more total healthcare visits and an additional $215.40 (95% CI, 210.76 to 220.00; P

Diagnostic accuracy of three prevailing rapid antigen tests for detection of SARS-CoV-2 infection in the general population: cross sectional study (preprint)

Objective To assess the diagnostic accuracy of three rapid antigen tests (Ag-RDTs) for detecting SARS-CoV-2 infection in the general population. Design Cross-sectional study with follow-up using pseudonymised record linkage. Setting Three Dutch public health service COVID-19 test sites. Participants Consecutively included individuals aged 16 years and older presenting for SARS-CoV-2 testing. Main outcome measures Sensitivity, specificity, positive and negative predictive values of BD-Veritortm System (Becton Dickinson), PanBio (Abbott), and SD-Biosensor (Roche Diagnostics), applying routinely used sampling methods (combined oropharyngeal and nasal [OP-N] or nasopharyngeal [NP] swab), with molecular testing as reference standard. For SDBiosensor, the diagnostic accuracy with OP-N sampling was also assessed. A viral load cutoff ([≥]5.2 log10 SARS-CoV-2 E-gene copies/mL) served as a proxy of infectiousness. Results SARS-CoV-2 prevalence and overall sensitivities with 95% confidence intervals were 188/1441 (13.0%) and 129/188 (68.6% [61.5%-75.2%]) for BD-Veritor, 173/2056 (8.4%) and 119/173 (68.8% [61.3%-75.6%]) for PanBio, and 215/1769 (12.2%) and 160/215 (74.4% [68.0%-80.1%]) for SD-Biosensor with routine sampling, and 164/1689 (9.7%) and 123/164 (75.0% [67.7%-81.4%]) for SD-Biosensor with OP-N sampling. In those symptomatic or asymptomatic at sampling, sensitivities were 72.2%-83.4% and 54.0%-55.9%, respectively. With a viral load cut-off, sensitivities were 125/146 (85.6% [78.9%-90.9%]) for BD-Veritor, 108/121 (89.3% [82.3%-94.2%]) for PanBio, 160/182 (87.9% [82.3%-92.3%]) for SD-Biosensor with routine sampling, and 118/141 (83.7% [76.5%-89.4%]) with OP-N sampling. Specificities were >99%, and positive and negative predictive values >95%, for all tests in most analyses. 61.3% of false negative Ag-RDT participants returned for testing within 14 days (median of 3 days, interquartile range 3) of whom 90.3% tested positive. Conclusions The overall sensitivities of the three Ag-RDTs were 68.6%-75.0%, increasing to at least 85.6% after the viral load cut-off was applied. For SD-Biosensor, the diagnostic accuracy with OP-N and NP sampling was comparable. Over 55% of false negative Ag-RDT participants tested positive during follow-up.

Caregivers of people with dementia and mental health during COVID-19: findings from a cross-sectional study. (preprint)

Background: There is sparse evidence on the impact on vulnerable populations of the COVID-19 pandemic. The aim of our study was to explore burden and mental wellbeing (including depressive, anxiety, and stress symptoms) in caregivers of people with dementia during the first wave of the pandemic in Italy and southern Switzerland, two bordering regions severely hit by the COVID-19 pandemic. Methods We conducted an online cross-sectional survey with family carers of people with dementia between May and June 2020. We registered socio-demographic characteristics, and information about the relationship with the care recipient, dementia subtype, care inputs from others, and the need of care of the person with dementia. We measured caregiver burden with the Zarit Burden Interview (ZBI), psychological distress with the Depression, Anxiety and Stress Scale (DASS-21), and perceived isolation with the 3-item UCLA Loneliness Scale (UCLALS3). Results Caregivers (N=571) reported moderate to severe care-related burden (mean=54.30; SD=18.33), moderate anxiety symptoms (mean=10.04; SD=6.93), mild depressive symptoms (mean=11.79; SD=6.12) and mild stress (mean=12.95; SD=5.53), and 72.3% of participants reported to feel lonely. All scores were significantly more severe in Swiss compared to Italian caregivers (all p values<0.001). Conclusions We found that caregivers’ burden, anxiety symptoms, depression and perceived loneliness were marked during the first wave of the COVID-19 pandemic, in two severely hit bordering countries. Regional differences in the impact of the epidemic on caregivers could be due to contextual, societal, and cultural circumstances. As the pandemic endures, support to caregivers of people with dementia should be proportionate and tailored to needs and adapted to contextual factors.

COVID-19 Vaccine Uptake and Its Impacts in a Cohort of Gay and Bisexual Men in Australia (preprint)

Restrictions imposed due to COVID-19 have constrained social interactions, including sexual contacts. COVID-19 vaccine hesitancy restricts population-level vaccine coverage. Many gay and bisexual men (GBM) have successfully employed biomedical forms of HIV risk-reduction, which may predispose them to vaccination against COVID-19, which may, in turn, affect their sexual behavior.Australian GBM provided weekly data on the impact of COVID-19 for a prospective observational study. A total of 622 men reported their vaccination history, sexual behaviour, and social connectedness between 17 January 2021 and 22 June 2021. We describe rates and types of vaccination over time, identify factors associated with vaccination, and compare sexual behavior before and since vaccination. Mean age was 47·3 years (SD 14·0). Most identified as gay (89·5%) and 9·2% were HIV-positive. At least one-dose vaccination coverage had reached 57·2%, and 61·3% reported that the majority of their friends intended to be vaccinated. Vaccinated men were older (aOR=1·07; 95%CI=1·05-1·09) and tested more often for COVID-19 (aOR=1·15; 95%CI=1·05-1·25). Men who were not vaccinated were more sceptical about COVID-19 vaccines. Vaccinated men reported a mean of 1·11 (SD=2·10) non-relationship sex partners before vaccination and 1·62 (SD=3·42) partners following vaccination (p=0·030).GBM, and their peer networks, demonstrated high confidence in COVID-19 vaccines. Men who were less sceptical of the safety of the vaccines were more likely to vaccinate. Men were also more likely to increase sexual activity following vaccination suggesting that greater sexual freedom may be a specific motivation for vaccine uptake among some men.Funding Information: The Kirby Institute, Centre for Social Research in Health, and the Australian Research Centre in Sex, Health and Society are funded by the Australian Government Department of Health. The Flux study has received funding from the Australian Research Council (2014-2018) and the New South Wales Ministry of Health, via the BBV and STI Research, Intervention and Strategic Evaluation (BRISE) program, STIs and Viral Hepatitis. In 2018, Flux was partly funded by the Gilead Sciences Australia Fellowship Research Grants Program. LM, BRB, BH are supported by the award of a NHMRC Research Fellowship. Declaration of Interests: The authors have no conflicts of interest to disclose.Ethics Approval Statement: Participants provided online informed consent, and enrolment was verified upon activating a link via email. Ethical approval was granted from UNSW Sydney.

Nocebo-Prone Behavior Contributes to SARS-CoV-2 Vaccine Hesitancy in Healthcare Workers (preprint)

Background: (298 w)Vaccine hesitancy among healthcare workers (HCWs) represents a major challenge in the global fight against COVID19. A skeptical approach to vaccination could be linked to a higher susceptibility to nocebo effects, i.e. adverse events (AEs) experienced after medical treatments due to negative expectations. However, the association of nocebo-prone behavior with SARS-COV-2 vaccination hesitancy and tolerability has not been studied.Methods: A cross-sectional, multicenter, face-to-face survey was performed with a self-completed questionnaire that was delivered to a representative sample of HCWs of five tertiary hospitals in Athens four months after the SARS-COV2 vaccination rollout for HCWs. The questionnaire was designed to capture the reasons for vaccination hesitancy, vaccination-related AEs, and nocebo prone behavior, by a validated tool (Q-No) for the identification of nocebo-prone individuals. Findings: A total of 1,309 HCWs (67·2%women; 43·4% physicians; 28·4% nurses; 11·5% administrative staff; 16·6% other personnel) completed the questionnaires (90·7% participation rate), among whom 237 (18·1%) had declined vaccination. Q-No scores were ≥15 in 325 participants (24·8%, mean age±SD=43·2±11·3), suggesting nocebo-prone behavior. Odds of vaccination were 57% lower in participants with Q-No score ≥15, than in those with a score <15 (OR=0.43, 95% CI:0.30-0.60), and 42% lower in females than men (OR=0.58, 95% CI:0.30-0.60), while physicians had higher odds of vaccination (OR=4.73, 95% CI:3·1-7·3) as compared to other HCWs. At least one AE was reported by 67·5% of vaccinees, mostly local pain and flu-like symptoms. Females and physicians had a higher probability to report AEs, which was not affected by the Q-No score. Interpretation: Nocebo-prone behavior in HCWs as captured by the Q-No tool is associated with SARS-CoV-2 vaccination hesitancy. These findings point to a role of nocebo-related mechanisms in the development of vaccination hesitancy, and a potential benefit of a campaign focused on the nocebo effect with regard to improved vaccination rates.Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: This study was approved by the Ethic Committees of all five Hospitals.

A Learning Health System Approach to the COVID-19 Pandemic: System-Wide Changes in Clinical Practice and 30-Day Mortality Among Hospitalized Patients (preprint)

ABSTRACT Introduction Rapid, continuous implementation of credible scientific findings and regulatory approvals is often slow in large, diverse health systems. The COVID-19 pandemic created a new threat to this common “slow to learn and adapt” model in healthcare. We describe how UPMC committed to a rapid learning health system (LHS) model to respond to the COVID-19 pandemic. Methods An observational cohort study was conducted among 11,429 hospitalized patients from 22 hospitals (PA, NY) with a primary diagnosis of COVID-19 infection (March 19, 2020 – June 6, 2021). Sociodemographic and clinical data were captured from UPMC electronic medical record (EMR) systems. Patients were grouped into four time-defined patient “waves” based on nadir of daily hospital admissions, with wave 3 (September 20, 2020 – March 10, 2021) split at its zenith due to high volume with steep acceleration and deceleration. Outcomes included changes in clinical practice (e.g., use of corticosteroids, antivirals, and other therapies) in relation to timing of internal system analyses, scientific publications, and regulatory approvals, along with 30-day rate of mortality over time. Results Mean (SD) daily number of hospital admissions was 26 (28) with a maximum 7-day moving average of 107 patients. System-wide implementation of the use of dexamethasone, remdesivir, and tocilizumab occurred within days of release of corresponding seminal publications and regulatory actions. After adjustment for differences in patient clinical profiles over time, each month of hospital admission was associated with an estimated 5% lower odds of 30-day mortality (adjusted OR = 0.95, 95% confidence interval: 0.92 – 0.97, p < .001). Conclusions In our large LHS, near real-time changes in clinical management of COVID-19 patients happened promptly as scientific publications and regulatory approvals occurred throughout the pandemic. Alongside these changes, patients with COVID-19 experienced lower adjusted 30-day mortality following hospital admission over time.

Impact of COVID-19 on head and neck cancer advancement measured by the increasing numbers of acute dyspnea cases. What can be improved for the future? (preprint)

Background: The COVID-19 pandemic has altered all aspects of how the healthcare system is organized, and impacted patients with head and neck cancer (HNC), who delayed diagnosis and treatment. The result was the increased admission of patients with severe dyspnea and a need for tracheotomy due to extremely advanced HNC. The aim of this study was evaluate the characteristics of two multi-center cohorts of HNC patients admitted for dyspnea. Methods: .. The therapeutic activity of four University Departments of Otolaryngology was studied over two time periods: September-February 2019/2020 and 2020/2021. Results: . A group of 136 HNC patients who underwent tracheotomy in two time cohorts, pre-COVID-19 (N = 59) and COVID-19 (N = 77), were analyzed. The mean tracheotomy incidence proportion was 1.82% (SD: 1.12) for the pre-COVID-19 and 3.79% (SD: 2.76) for the COVID-19 period. A rise in emergency dyspnea was observed in the COVID-19 cohort. In the pre-COVID-19 period, 66% of patients presented with symptoms for more than a month in comparison to 78% of patients in COVID-19 times (p = 0.04). The number of tracheotomies performed under general anesthesia dropped in favor of local anesthesia during COVID-19 (64% vs. 56% respectively) due to extremely advanced HNC. In the COVID-19 cohort, most patients received a telemedicine consultation (N = 55, 71%) compared to the pre-COVID-19 period (N = 14, 24%). Conclusions: . There should be a reorganization of the referral system, an adjustment of treatment capacity for an increased number of HNC patients, and a reserve for more extensive resection and reconstruction surgeries in ENT departments to not hamper future HNC treatment if there is another pandemic wave.

SARS-CoV-2 Postvaccination Infections Among Staff Members of a Tertiary Care University Hospital – Vienna, January-July 2021; an Exploratory Study on 8 500 Employees with Better Outcome of Vector than m-RNA Vaccine (preprint)

Background: The identification of SARS-CoV-2 antigen or RNA in a respiratory specimen collected from a person ≥14 days after completing all recommended doses of authorized COVID-19 vaccine series is a rare condition and defined as „breakthrough infection“. Data on mildly symptomatic or asymptomatic SARS-CoV-2 vaccine breakthrough infection cases especially with respect to viral characteristics and temporal relation to vaccination date is scarce. The purpose of the present investigation was to investigate the prevalence of postvaccination infections in hospital employees and to compare between m-RNA and vector based SARS-CoV-2 vaccines.Methods: At the General Hospital of Vienna 8 553 actively employed staff members participated at an voluntary in-house vaccination program, which took place between January and May 2021 and comprised of application of two doses of either COMIRNATY (BNT162b2; Pfizer/BioNTech, Inc.) or VAXZEVRIA (AstraZeneca, Inc.). Findings: By the end of July 2021 a total of 78 postvaccination infection cases after administration of a minimum of one dose of vaccination had been identified (median age: 40·5 years (IQR: 19-60 years); 53 women) of whom 53 had been vaccinated with VAXZEVRIA and 25 with COMIRNATY. The majority of infections was related to an insufficient or partial vaccination status; the incidence of postvaccination infection ≥14 days after complete vaccination (i.e. breakthrough infection) was 34·8: 10 000 for COMIRNATY and 8·8: 10 000 for VAXZEVRIA. There was no difference in PCR-CT values between the two vaccine brands (24·67 (SD: 7·41) for VAXZEVRIA vaccinated versus 24·0 (SD: 6·53) for COMIRNATY vaccinated persons). Genotyping of positive PCR specimens revealed 42 variant of concerns: B.1.1.7 (n=34); B.1.351 (n=2), B.1.617.2 (n=6). The prevalence of „real brakthrough infections“ (≥14 days after second vaccination) was higher in COMIRNATY vaccinated subjects than in the VAXZEVRIA vaccinated subjects with a ratio of 14:4 (p<0,01). Interpretation: mRNA and vector vaccines against COVID-19 are both highly effective in protecting against a broad genomic spectrum of SARS-CoV-2 infections, at least with respect to severe illness. In the present investigation VAXZEVRIA was more effective than COMIRNATY with respect to prevent breakthrough infections after full immunization, however, it seems important, that all recommended vaccine doses are applicated. Maintaining distinct precautions and ongoing testing, at least for the immediate period after vaccination, to detect asymptomatic infections is highly recommended.Funding: None to declare. Declaration of Interest: We decline no conflicting interest. Ethical Approval: The study was approved by the ethics committee of the Medical University of Vienna [No.1721/2021] and the medical directorate of the hospital.

Trajectories of Hypoxemia & Pulmonary Mechanics of COVID-19 ARDS in the NorthCARDS Dataset (preprint)

Background:  Understanding heterogeneity seen in patients with COVIDARDS and comparing to non-COVIDARDS may inform tailored treatments.  Methods:  A multidisciplinary team of frontline clinicians and data scientists worked to create the Northwell COVIDARDS dataset (NorthCARDS) leveraging over 11,542 COVID-19 hospital admissions. The data was then summarized to examine descriptive differences based on clinically meaningful categories of lung compliance, and to examine trends in oxygenation. Findings:  Of the 1595 COVIDARDS patients in the NorthCARDS dataset, there were 538 (34·6%) who had very low lung compliance (<20ml/cmH 2 O), 982 (63·2%) with low-normal compliance (20-50ml/cmH 2 O), and 34 (2·2%) with high lung compliance (>50ml/cmH 2 O). The very low compliance group had double the median time to intubation compared to the low-normal group (107 hours (IQR 26·3, 238·3) vs. 37·9 hours (IQR 4·8, 90·7)). Overall, 67·5% (n=1049) of the patients died during the hospitalization. In comparison to non-COVIDARDS reports, there were less patients in the high compliance category (2.2%vs.12%, compliance ≥50mL/cmH20), and more patients with P/F ≤ 150 (57·8% vs. 45.6%). No correlation was apparent between lung compliance and P/F ratio. The Oxygenation Index was similar, (11·12(SD 5·67) vs.12·8(SD 10·8)). 1  

Prevalence and predictors of self-medication drugs to prevent or treat COVID-19: experience from a Middle Eastern country (preprint)

Background: Lack of definitive cure for COVID-19 and the late introduction of a vaccine were responsible to push the general public to look for a remedy to treat or prevent COVID-19. The objective of this study was to evaluate patterns and factors that affect self-medication practices in Jordan during the pandemic. Methods This was a cross-sectional study using an online questionnaire that was developed, piloted and distributed to the general public via various social media platforms. The questionnaire assessed the type of drugs and treatments used to self -medicate, the reasons behind their self- medication, and the factors affecting their practices. Results A total of 1179 participants (females 46.4%) with a mean age of 32 (SD=12.5) completed the questionnaire. The overall prevalence of the use of at least one product to treat or prevent COVID-19 was 80.4 %. The most commonly used products to self-medicate were vitamin C (57.6%), followed by paracetamol (51.9%), zinc (44.8%) and vitamin D (32.5%). Female gender (odds ratio [OR]) = 1.603, working in the medical field (OR =1.697), and history of COVID-19 infection (OR =2.026) were variables associated with self-medication. The most common sources of participants’ information about drugs to prevent or treat COVID-19 were newspapers (n=519, 44.0%), followed by pharmacists (43.4%), friends (33.8%) and internet searching such as Google (30.7%). Conclusion This study identified the main drugs and supplements used during COVID-19 and the motives behind their use. It also identified the most influential source of information on the public during the pandemic. Self-medication can lead to worsening of the patient’s health and delay seeking medical advice from healthcare professionals. Efforts should be done to help mitigate risks of self-medications by active involvement of pharmacists and other members of healthcare team to refute false claims about drug, especially in the media.

Examining the Relationship between COVID-19 Vaccinations and Reported Incidence (preprint)

As COVID-19 has caused significant morbidity and mortality throughout the world, the development and distribution of an effective vaccine have been swift but not without challenges. Earlier demand and access barriers have seemingly been addressed with more free and accessible vaccines now available for a wide variety of ages. While rates of COVID-19 have decreased overall, some geographic areas continue to experience rapid outbreaks. The purpose of this study was to examine the relationship between vaccination uptake and weekly COVID-19 cases throughout locations in the state of Missouri. Methods Among all Missouri counties and two cities (n=117), weekly COVID-19 incidence and cumulative proportion of residents fully vaccinated were abstracted from the Missouri Department of Health and Senior Services during a 25-week period from January 4 to Jun 26, 2021. Additional ecological variables known to be associated with COVID-19 incidence and prevalence were collected from the U.S. Census Bureau and integrated into data: total population, proportion of nonwhite residents, annual median household income, proportion of residents working in public facing occupations. Descriptive and inferential statistics were completed which included the calculation of both linear and nonlinear models using repeated measure data to determine the quantitative association between vaccination uptake and reported COVID-19 cases in the presence of location characteristics. Results Throughout the 25 weeks of observations, the average weekly number of COVID-19 cases reported was 66.1 (SD=260.8) while the average cumulative proportion vaccinated individuals at the end of the 25 weeks was 25.8% (SD=6.8%) among study locations. While graphing seemed to suggest a more nonlinear relationship between COVID-19 incidence and proportion vaccinated, comparison of crude linear and nonlinear models pointed to the relationship likely being linear during study period. The final adjusted linear model exhibited a significant relationship between COVID-19 cases and proportion vaccinated, specifically every percent increase in population vaccinated resulted in 3 less weekly COVID-19 cases being reported (β -3.74, p<0.001. Additionally, when controlling for other factors, the adjusted model revealed locations with higher proportions of nonwhite residents were likely to experience less weekly COVID-19 cases (β -1.48, p=0.037). Discussion Overall, this study determined that increasing the proportion of residents vaccinated decreases COIVD-19 cases by a substantial amount over time. These findings provide insights into possible messaging strategies that can be leveraged to develop more effective implementation and uptake. As the COVID-19 pandemic persists and vaccination numbers begin to plateau, diverse communication strategies become a critical necessity to reach a wider population.

Beliefs Toward Smoking and COVID-19, and The Pandemic Impact on Smoking Behavior and Quit Intention: Findings from a Community-Based Cross-Sectional Study in Jordan (preprint)

Background: The relationship between smoking and Coronavirus Disease-2019 (COVID-19) is still topical with mixed epidemiological evidence. However, the pandemic may affect people’s beliefs towards smoking as well as smoking behavior and quit intentions. Considering high smoking rates in Jordan, our current study aimed to assess the following points in a community-based sample from Jordan: (i) the beliefs that surround smoking and COVID-19, (ii) the pandemic impact on smoking behavior and quit intention. Methods: : A cross-sectional study was conducted in Jordan utilizing an online questionnaire. The questionnaire comprised 13 items on sociodemographic, health, and smoking profiles, 14 items to assess beliefs surrounding COVID-19 and the use of combustible cigarettes (CC), waterpipe (WP), and electronic cigarettes (EC), and 12 items to assess the pandemic impact on smoking behavior and quit intention. Results: Of 2424 survey respondents who participated in our study there were 1163 never-smokers, 1044 current smokers, and 217 ex-smokers. The mean age of participants was 35.2 years (SD:11.06). Most participants have shown anti-smoking beliefs with around 72.9% believed that WP smoking is related to the risk of contracting COVID-19. Also, 71.7% believed that smoking CC may worsen the COVID-19 clinical course, while 74.1% of respondents believed that smoking has no protective effect against COVID-19. During the pandemic, about 28.1% and 19.3% of current smokers reported increased or reduced smoking, respectively, and many smokers reported their willingness to quit smoking due to the pandemic. Besides, 459 current smokers have expressed their plans/intention to quit smoking during the pandemic, of whom 27.5% (n=126) confirmed that the driving force for their decision is a COVID-19 related reason, such as self-protection (n=123) and protection of family members (=121) which were the most reported ones. Also, around 63 participants have successfully ceased smoking during the pandemic. However, only 22 of them reported that the main driving motivation of their successful quit attempt was the COVID-19 pandemic. Conclusion: Most participants reported anti-smoking beliefs and attitudes during the pandemic. Nevertheless, the double-edged effect of the pandemic on smoking habits should be carefully considered, and reliable anti-smoking measures should be strengthened and sustained in the country.

Comparing India's Second COVID Wave With the First Wave – A Single-Center Experience (preprint)

Background: The COVID-19 pandemic has resurfaced in India in the form of a hard-hitting second wave. This study aims to compare the clinical profile of the first wave (April-June 2020) and the second wave (March-May 2021) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a single tertiary care center of India. This will help prioritize the target population group and management strategies in the upcoming third wave if any. Methods: In this retrospective observational study, we examined the demographic profile, symptoms at presentation, the severity of illness, baseline investigations, treatments received, underlying comorbidities, and outcomes of the COVID-19 patients belonging to the first (W1) and the second wave (W2) of the pandemic in India. Findings: The age group affected most in the W2 is 50.5 (SD=17.7) years compared with 37·1 (SD=16·9) years for the W1. The baseline oxygen saturation is lower in W2, being 84·0 (13·4) % compared with 91·9 (7·4) % in W1. 70.2 % of the cases belonged to the severe category in W2 compared to 37.5% in W1. W2 patients demonstrated higher transaminase levels [SGOT, 108.3 (99.3) v/s 54.6 (69.3); SGPT, 97.6 (82.3) v/s 58.7 (69.7)] with respect to W1. Similarly, the CT severity score for W2 [29.5 (6.7)] was higher than W1 [23·2 (11·5)][All P<0.05]. The proportion of patients requiring oxygen (81.8% v/s 11.2%), high flow nasal cannula (11.4% v/s 5.6%), non-invasive ventilation (41.2% v/s 1.5%), invasive ventilation (24.5% v/s 0.9%), as well as ICU/HDU admissions (56.4% v/s 12.0%) was higher for W2 as compared with W1. The measured case fatality rate varies from 29% for W2 to 9.6% for W1. Interpretation: Higher age, oxygen requirement, ventilator requirement, ICU admission, and organ impairment are more prevalent in the admitted COVID-19 cases during the second wave that has hit India compared to the first wave and associated with more fatalities. Strategy for another wave should be planned accordingly.Funding Information: None.Declaration of Interests: We declare that we have no conflicts of interest.Ethics Approval Statement: Ethical approval was obtained (CTRI/2020/08/027169).

Across the COVID-19 Waves; Assessing Temporal Fluctuations in Perceived Stress, Post-Traumatic Symptoms, Worry, Anxiety and Civic-Moral Disengagement Over One Year of Pandemic (preprint)

Background: This study aimed to investigate the psychological effect of the COVID-19 pandemic in Italy, by analysing the trends of Perceives stress, Post-traumatic symptoms, State anxiety, Worry, and Civic moral disengagement during four times, from March 2020, to March 2021.Methods: The study involved total of 1827 Italian participants (30% Men and 70% Women; Mage = 34·72; SD = 12·40), divided in four groups, to which an online survey including several self-report measures was administered. The first group (N = 814; Men and 68% Women; Mage = 35·85; SD = 12·38) completed the survey in March 2020; the second one (N = 523; % Men and 74% Women; Mage = 32·87; SD = 10·55) in August 2020, the third one (N = 250; % Men and 61% Women; Mage = 36·57; SD = 14·57) in November 2020; the fourth one (N = 240; 23% Men and 77% Women; Mage = 33·00; SD = 13·80) in March 2021.Outcomes: Results highlighted significant decreases in Post-traumatic symptoms, State anxiety, Worry, and a significant increase in Civic moral disengagement over first year of the COVID-19 pandemic. The levels of Perceived stress remained constant.Interpretation: The COVID-19 emergency has significant effects on the mental state of the population, with important repercussions for individual and collective well-being during, but also after, the pandemic. This study offers a clear snapshot of the psychological outcomes over a COVID-19 pandemic year, providing important information that may contribute to tailor more effective intervention for mental health.Funding Statement: This research received no external funding.Declaration of Interests: The authors declare no conflict of interest.Ethics Approval Statement: Procedures were carried out according to current ethical guidelines and were approved by the Ethical Committee of the Integrated Psychodynamic Psychotherapy Institute (IPPI; ethical approval number 001/2020).