ABSTRACT
Background: Healthcare workers (HCW) of respiratory clinics are at major risk for SARS-CoV-2-infection. COVID-19 prevalence among HCWs in the pre-vaccination era is well documented but the effect of vaccination on COVID-19disease and development of symptoms is less well studied. One year after start of the vaccination campaign, we aimed to determine the work-related risk among HCWs of respiratory clinics in Germany. Method(s): A study-specific online questionnaire was created to investigate COVID-19 work-related risk and disease characteristics. HCWs of all occupational categories were surveyed from 1st to 23th Dec 2021. Result(s): 1136 HCWs of seven clinics, 75% females, age groups 18-25/26-35/36-45/46-55/>=56y 8.1/24.9/22.6/23.7/20.5%, took part. Overall SARS-CoV-2 prevalence was 9.5% (n=108), 55.9% occurring before introduction of vaccination. 82.3/6.5/11.2% were unvaccinated/single dose/double dose vaccinated at infection. Most infections were associated with hospital exposure in the unvaccinated, 45.5 vs. 18.2%, whereas infections after vaccination were predominantly attributed to private contacts, 21.1 vs. 42.1% (p=0.04). The majority of infected subjects (89%) were symptomatic at diagnosis. Regardless of vaccination status, 43.8 and 55.2% experienced dysgeusia/anosmia and fatigue, respectively, as severe. HCWs who were unvaccinated at the time of infection reported a higher symptom burden after recover. Conclusion(s): One year after start of the vaccination campaign, a decrease in workplace-related COVID-19 infections was observed, but a relevant number of the formerly infected still suffered from sequelae.
ABSTRACT
Background: Staff absences due to illness or quarantine as result of the SARS-CoV-2 pandemic or vaccinationrelated adverse events are known. We examined their numbers in health care workers (HCW) from pulmonary hospitals in Germany. Method(s): A study-specific online questionnaire was created to assess individual experiences and the impact of the pandemic. From December 1 to 23, 2022 staff from all occupational groups at 7 pulmonary hospitals were surveyed. Result(s): A total of 1136 HCW participated, 75% being female, 92.6% having received at least one vaccine dose at the time of the survey, 65.2% three, and 108 reporting a previous SARS-CoV-2 infection. Of HCW with positive PCR test, 98% reported home quarantine, with a quarantine period of median (range) 14 (1-52) days, while of those without positive PCR test, 11.3% reported quarantine over 14 (1-25) days. In addition, 23.5% of HCW reported absences due to vaccination effects over 2 (1-21) days. Overall, 37% (n=420) of HCW reported pandemic-related absences (median 5 days), with 3523 cumulative days of absence from work, among them 2826 related to illness or quarantine, and 697 to vaccination effects. Independent risk factors for pandemic-related absences of more than 5 days included COVID-19 illness (p<0.001) and not having been vaccinated at the time of the interview (OR 2.6;95%CI: 1.2-5.6;p= 0.009). Sex, age, or working in direct patient care or risk areas were not relevant. Conclusion(s): In HCW from German pulmonary hospitals, the average total days of absenteeism from work related to SARS-CoV-2 were about 3 days per participant, and vaccination-associated absenteeism contributed about one fifth to this number.
ABSTRACT
Background. Patients with hematological malignancy or other cancers as well as immunosuppression bear a high risk for severe COVID-19. Monoclonal antibodies (mAb) are efficient at early stages of the disease but may lose potency with new variants. Trials on plasma from convalescent donors in unselected patients have not shown clinical benefit. No randomized trials focussing on patients with underlying disease have been published. Methods. We conducted an open-label, multicenter, randomized controlled trial to evaluate efficacy of plasma (CVP - convalescent or after vaccination) in patients with COVID-19 at high risk for adverse outcome in Germany. We assessed the effect of high-titer CVP (2 units from different donors, 238-337 ml each, on subsequent days). Patients with hematological or other malignancy (group 1), immunosuppression (group 2), age >50 and <=75 years and lymphopenia and/or high D-dimers (group 3) or age >75 years (group 4) who were hospitalized with confirmed SARS-CoV-2 infection and with an oxygen saturation <=94% were included. Primary outcome measure was time to clinical improvement on a seven-point ordinal scale, secondary outcome was mortality (Janssen et al. Trials 2020 Oct 6;21(1):828). Results. Overall, 133 patients were randomized, 68 received CVP with an additional 10 patients as a crossover on day 10. Median age (range) was 68 years (39-95) in the CVP group and 70 (38-90) in controls. For the entire cohort, no significant difference was seen in time to improvement (median days: CVP 12.5 vs. control 18;HR 1.24 (95% confidence interval (CI) 0.83-1.85), p=0.29). Subgroup analysis (group 1+2) revealed shortened time to improvement (median days CVP 13 vs. control 32;HR 2.03 (95%CI 1.17-3.6), p=0.01) and mortality was reduced (mortality CVP n=6 (18%) vs. control n=10 (29%). No significant differences in time to improvement were observed in group 3 or 4 (HR 0.72 (95%CI 0.41-1.28), p=0.26). No relevant adverse events were observed. Conclusion. CVP improves time to clinical improvement and mortality for COVID-19 patients with underlying hematological disease/cancer or other reasons of impaired immune response. Even with new variants, high-titer CVP may offer a widely available and inexpensive therapy option in high-risk groups. Funding. BMBF FKZ 01KI20152;EudraCT 2020-001632-10.
ABSTRACT
Background: Therapy options are limited for COVID-19 patients with hematological disease, cancer, immunosuppression or adanced age. Een though no benefit was obsered for conalescent plasma in unselected patients with COVID-19, retrospectie data suggest that it could be effectie in patients unable to mount a sufficient immune response upon SARS-CoV-2 infection. Plasma from accinated donors has not been systematically assessed for COVID-19 treatment. Aims: We conducted a randomized clinical trial to address plasma efficacy in patients at high risk for an aderse outcome. Methods: COVID-19 patients with confirmed SARS-CoV-2 infections and oxygen saturation <=94% were randomized (NCT05200754). Patients receied conalescent or accinated SARS-CoV-2 plasma in two bags (238 - 337 ml plasma each) from different donors on day 1 and 2 (PLASMA) or standard of care (CONTROL). Randomization was stratified according to four clinical patient groups, hematological/solid cancer (group-1), treatment or disease associated immunosuppression (group 2), high risk disease by standard parameters (group-3) or age >=75 years (group-4). Mechanically entilated patients were not eligible. Plasma was obtained from donors with high leel neutralizing actiity (titer >=1:80) either after SARS-CoV-2 infection (conalescent) or after accination with at least two doses of mRNA accines (accinated). Crossoer for the control group was allowed at day 10. The primary endpoint was time to improement as two points on a seen-point ordinal scale or lie discharge from the Hospital (IMPROVEMENT) with prespecified analyses of subgroups (Janssen M, et al. Trials 2020 Oct 6;21(1):828). Results: A total of 133 patients were randomized with 68 receiing PLASMA with a median age of 68 years (range 36-95) or CONTROL (n=65, of which n=10 (15.4%) crossed oer at day 10) with a median age of 70 years (range 38-90). The distribution of the four predefined groups was group-1, n=53;group-2, n=18;group-3, n=35;and group-4, n=27. The intention to treat analysis reealed a non-significant shorter time to IMPROVEMENT for patients in PLASMA (median 12.5 days, 95%-CI [10;16]) compared to patients in CONTROL (median 18 days, 95%-CI [11;28] ), hazard ratio 1.24, 95% confidence interal [0.83;1.85], p=0.29). Oerall, 27 patients died (PLASMA, n=12;CONTROL, n=15;p=0.80). Predefined subgroup analysis reealed a clinically significant benefit in patients with hematological malignancies, other cancers or immunosuppression (group-1, group-2, n=71). With a median time to improement of 13 days (95%-CI [9;19]) for PLASMA and 32 days (95%-CI [17;57]) for CONTROL(HR 2.03, 95%-CI [1.17;3.6], p=0.01). A sensitiity analysis reealed that IMPROVEMENT appeared to be seen een earlier with accinated (median 10 days, 95%-CI [8;14]) compared to conalescent SARS-CoV-2 plasma (median 13 days, 95%-CI [6;38]) and CONTROL. Within group-1 and group-2, six patients in PLASMA (18.2%) and 10 in CONTROL (28.6%) died. No significant differences in improement were obsered in group-3 and group-4 with a HR of 0.72 (95%-CI [0.41;1.28], p=0.26). Within group-3 and group-4, six patients in PLASMA (18.8%) and fie in CONTROL (16.7%) died. No preiously unknown side effects of plasma therapy emerged within the trial. Summary/Conclusion: Plasma from conalescent and particularly accinated donors improed outcome of COVID-19 patients with an underlying hematological disease /cancer or other reasons of impaired immune response. Plasma did not improe outcome in immune-competent patients with other risk factors and/or older age. (Figure Presented).
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Background: Due to the novelty of COVID19 there is lack of evidence-based recommendations regarding the mechanical ventilation of these patients. Objective: Identification and delineation of critical parameters enabling individualized lung and diaphragm protective mechanical ventilation. Material and methods: Selective literature search, critical evaluation and discussion of expert recommendations. Results: In the current literature a difference between ARDS in COVID19 and classical ARDS is described; however, there are no evidence-based recommendations for dealing with this discrepancy. In the past parameters and approaches for a personalized mechanical ventilation strategy were already introduced and applied. Conclusion: Using the parameters presented here it is possible to individualize the mechanical ventilation of COVID19 patients in order to adjust and increase its compatibility to the heterogeneous clinical presentation of the COVID19 ARDS.
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Background: Most data on COVID-19 was collected in hospitalized cases. Much less is known about the spectrum of disease in entire populations including nonhospitalized patients and minors. In this study, we examine a representative cohort in an administrative district in Southern Germany who tested positive for SARS-CoV-2 between February and June of 2020. Methods: We contacted all confirmed SARS-CoV-2 cases in an administrative district in southern Germany. Consenting participants answered a retrospective survey either via a telephone, electronically or via mail. Clinical and sociodemographic features were compared between hospitalized and non-hospitalized patients. Additionally, we assessed potential risk factors for hospitalization and time to hospitalization in a series of regression models. As predictors we assessed age as a continuous variable, sex, smoking as a continuous variable using pack years, living with children (age <18), hypertension (yes/no), coronary heart disease (CHD;yes/no), diabetes (type 1 or type 2;yes/no) and lung conditions (yes/no). Lung conditions were defined as a combined variable of either COPD, asthma treated with medications, any other lung disease or previously performed lung surgery. Secondly, we estimated the influence of the same covariates on the time from symptom onset to hospitalization with a Cox proportional hazard ratio (HR) model. Results: We included 897 participants in our study, 69% out of 1,305 total cases in the district with a mean age of 47 years (range 2-97), 51% of which were female and 47% had a pre-existing illness. The percentage of asymptomatic, mild (symptomatic, no hospitalization), moderate (leading to hospital admission) and critical illness (requiring mechanical ventilation) was 54 patients (6%), 713 (79%), 97 (11%) and 16 (2%), respectively. Seventeen patients (2%) died. The most prevalent symptoms were fatigue (65%), cough (62%) and dysgeusia (60%). The risk factors for hospitalization included older age (OR 1.05 per year increase;95% CI 1.04-1.07) preexisting lung conditions (OR 3.09;95% CI 1.62-5.88). Female sex was a protective factor (OR 0.51;95% CI 0.33-0.77). Conclusion: This population-representative analysis of COVID-19 cases confirms age, male sex and preexisting lung conditions but not cardiovascular disease as risk factors for severe illness. Almost 80% of infection take a mild course, whereas 13% of patients suffer moderate to severe illness.