Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 10 de 10
Filter
1.
55th Annual Hawaii International Conference on System Sciences, HICSS 2022 ; 2022-January:7111-7120, 2022.
Article in English | Scopus | ID: covidwho-2303268

ABSTRACT

A common baseline is that Agile-based software development is conducted by co-located teams working in well-equipped office workspaces. The COVID-19 pandemic and subsequent lockdowns have cast new light on those assumptions. Suddenly, developers were no longer co-located with their teams and their well-equipped workspaces were vacant. How did the lockdowns, and the speed in which they were implemented, affect developers and development efforts? Did the lockdowns lead to diminished product quality? How was employee productivity impacted? A survey questionnaire was created to answer these questions. © 2022 IEEE Computer Society. All rights reserved.

2.
Open Forum Infectious Diseases ; 9(Supplement 2):S474, 2022.
Article in English | EMBASE | ID: covidwho-2189766

ABSTRACT

Background. Peak SARS-CoV-2 viral replication occurs in the upper respiratory tract in presymptomatic and early symptomatic phases. Administration of a monoclonal antibody may be most beneficial in the early time period immediately after symptom onset. Here we describe the effect of early therapy on efficacy in patients receiving ADI. Methods. High risk patients with mild or moderate COVID-19 were enrolled in the ADI treatment study (STAMP), with primary endpoint of COVID-19 related hospitalization or all-cause death through Day 29 in patients with disease due to confirmed or suspected SARS-CoV-2 variants other than Omicron. Patients were randomized 1:1 to receive ADI or placebo administered by a single intramuscular (IM) injection. For this subgroup analysis, patients that had received therapy within 3 days of symptom onset were evaluated. Results. In the overall population, the study met the primary endpoint demonstrating 66% relative risk reduction of COVID-19 hospitalization or all cause death in 336 patients. Among 261 patients receiving therapy within 3 days of symptom onset (n=133 ADI, n=128 placebo), ADI was associated with a statistically significant reduction in the risk of COVID-19-related hospitalization or all-cause death through Day 29 compared with placebo (4 [3%] vs. 15 [11.7%], standardized risk difference -8%, 95% CI: -14.11, -1.86, p=0.0106), demonstrating a 72% standardized relative risk reduction in favor of ADI. When given as early therapy, ADI provided a greater reduction in viral load from baseline to Day 5 compared with placebo as assessed by saliva samples, with an adjusted least-squares mean difference of -0.97 log10 copies/mL (95% CI: -1.540, -0.391;p=0.0011). No study drug related SAEs, including deaths, and no hypersensitivity reactions were reported. Conclusion. Early therapy with a single dose of ADI 300 mg IM provided a 72% reduction in the risk of COVID-19 related hospitalization and all-cause death compared to placebo in high-risk ambulatory patients with mild to moderate COVID-19. Therapy within the first 3 days also led to a greater reduction in viral load compared to placebo and favorable outcomes in patients who are at high risk for progression of disease.

3.
Open Forum Infectious Diseases ; 9(Supplement 2):S323, 2022.
Article in English | EMBASE | ID: covidwho-2189666

ABSTRACT

Background. ADI is a fully human IgG1 monoclonal antibody engineered to have an extended half-life with high potency and broad neutralization against SARS-CoV-2 and other SARS-like coronaviruses with pandemic potential. Our objective was to develop a PPK model that describes the serum ADI concentration time profile following intravenous (IV) and intramuscular (IM) administration. Methods. The ADI PPK model was developed on PK data from a Phase 1 single ascending dose study (24 adults, IV and IM) and from Phase 2/3 COVID-19 prevention (EVADE;659 adults, IM) and treatment (STAMP;189 adults, IM) studies. 1,486 PK samples were included in the analysis. The impact of covariates (e.g. body weight, age, and baseline viral load) on ADI serum disposition were evaluated. Prediction-corrected visual predictive check (PC-VPC) plots were used to qualify the PPK model. Participant-specific ADI exposure estimates were generated using individual post hoc PK parameters. Results. The PPK model is comprised of 2 systemic compartments, zero-order infusion for IV administration and first-order absorption for IM administration and provided a robust fit to the data based on the PC-VPC plots and goodness-of-fit plots (data not shown). Body weight influenced clearance, inter compartmental clearance, and central and peripheral volume compartments. The relationship between body weight and clearance was not suggestive of the need for dose adjustment over the population weight range studied (38.6 to 178.7 kg). There was no apparent impact of baseline viral load or age on ADI clearance. The median [range] half-lives in days by study;Phase 1 (alpha1.71 [1.18-2.46];beta 125 [117-149]), Phase 2/3 prevention (alpha 1.86 [0.640-3.13];beta 136 [105-209]), and Phase 2/3 treatment (alpha 1.89 [0.631-3.01];beta 136 [108-206]). The population mean IM bioavailability estimate was 90.5%. The figure shows the PPK model median (90% confidence interval) concentration-time profile following a single 300 mg IM ADI dose by study. Conclusion. The PPK model provided a precise and unbiasedfit to the observed ADI concentration-time data and will be useful for future PK-pharmacodynamic analyses. Moreover, ADI demonstrated high IM bioavailability and a median terminal elimination half-life of 125 to 136 days.

4.
Open Forum Infectious Diseases ; 9(Supplement 2):S159, 2022.
Article in English | EMBASE | ID: covidwho-2189552

ABSTRACT

Background. Adintrevimab is a fully human IgG1 monoclonal antibody engineered to have potent and broad neutralization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other SARS-like CoVs with pandemic potential. Adintrevimab is being assessed in two separate phase 2/3 clinical trials: the EVADE trial for prevention of COVID-19 in both post-exposure and preexposure settings and the STAMP trial for treatment of COVID-19. Here we report higher doses being evaluated in a healthy volunteer study given that emerging variants may have varying susceptibilities to adintrevimab. Previous results 300 mg IM, 600 mg IM, and 500 mg IV cohorts have been reported. Methods. This is an ongoing Phase 1, randomized, placebo (PBO)-controlled, single ascending-dose study of adintrevimab administered intramuscularly (IM) or intravenously (IV) to healthy adults aged 18-50 years with no current SARS-CoV-2 infection. Participants were randomized 8:2 in 3 high dose cohorts (N=10/cohort: n=8 adintrevimab, n=2 PBO): adintrevimab 1200 mg IM, 1200 mg IV, and 4500 mg IV. Safety, tolerability, and pharmacokinetics (PK) were assessed up to 21 days post dose. Results. Overall, 30 participants received adintrevimab (n=24) or PBO (n=6). Blinded safety data for all cohorts and PK for 1200 mg IV are reported. Through 21 days post dose all doses were well-tolerated, with no study drug-related adverse events (AEs), serious AEs, injection site reactions, or hypersensitivity reactions reported. The observed PK profile of the 1200 mg IV dose included Cmax of 423+/-105 mug/ml. Comparison of 500 mg and 1200 mg IV doses indicate dose proportionality of Cmax and exposure (AUC Day 21). Conclusion. A single dose of adintrevimab, up to 4500 mg, was well tolerated. These preliminary safety data and PK support potential use of higher doses of adintrevimab as needed to address emerging SARS-CoV-2 variants.

6.
Open Forum Infectious Diseases ; 8(SUPPL 1):S420, 2021.
Article in English | EMBASE | ID: covidwho-1746398

ABSTRACT

Background. ADG20 is a fully human IgG1 monoclonal antibody engineered to have high potency and broad neutralization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other SARS-like CoVs with pandemic potential by binding to a highly conserved epitope in the receptor-binding domain (RBD) of the spike protein. The Fc region of ADG20 has been modified to provide an extended half-life. ADG20 is in clinical development for the treatment and prevention of COVID-19. Methods. This is an ongoing Phase 1, randomized, placebo (PBO)-controlled, single ascending-dose study of ADG20 administered intramuscularly (IM) or intravenously (IV) to healthy adults aged 18-50 years with no evidence of prior or current SARS-CoV-2 infection. Participants were randomized 8:2 in 3 cohorts (N=10/cohort: n=8 ADG20, n=2 PBO): ADG20 300 mg IM, 500 mg IV, and 600 mg IM. Safety, tolerability, PK, and sVNA titers were assessed up to 3 months post dose. Serum ADG20 concentrations were measured with a validated hybrid ligand binding liquid chromatography-mass spectrometry (MS)/MS assay. sVNA titers against authentic SARS-CoV-2 were determined by a plaque reduction neutralization assay. Results. Overall, 30 participants received ADG20 (n=24) or PBO (n=6). Blinded safety data for all cohorts and PK/sVNA titer data for the 300 mg IM cohort are reported. Through a minimum of 10 weeks post dose, no study drug-related adverse events (AEs), serious AEs, injection site reactions, or hypersensitivity reactions were reported. The observed preliminary PK profile was dose proportional, consistent with an extended half-life monoclonal antibody, and well predicted by translational physiologically-based PK modeling. The measured 50% sVNA titer (MN50;geometric mean [coefficient of variation, %]) was 1382 (32.7%) 13 days after a single 300 mg IM dose. These values are within the range of peak serum neutralizing antibody titers reported for COVID-19 mRNA vaccines. Conclusion. A single dose of ADG20, up to 600 mg IM, was well tolerated. Preliminary PK and sVNA titer profiles support the ongoing Phase 2/3 trials of ADG20 at a 300 mg IM dose for the prevention of COVID-19 (EVADE: NCT04859517) and treatment of ambulatory patients with mild to moderate COVID-19 (STAMP: NCT04805671).

7.
16th International Conference on Electronics Computer and Computation, ICECCO 2021 ; 2021.
Article in English | Scopus | ID: covidwho-1714051

ABSTRACT

During the COVID-19 pandemic, methods to determine the presence of coronavirus are very relevant. In this article, a new method has been developed to detect the presence of the SARS-CoV-2 virus in the air. The article analyzes in detail the signs indicating favorable conditions for the spread of the virus. The influence of changes in temperature, humidity, the presence of particles in the air, the level of CO2 and the ventilation of the room on the probability of infection with the virus is considered.Based on the studied parameters, a model was built. It allows to detect the probability of the threat of the spread of the virus. The model was implemented as a fuzzy controller in the Matlab environment. The studied parameters were taken as input parameters for constructing the model. The output parameter was the detector value indicating the presence or absence of a virus in the air.Thus, the built system allows detecting situations in which coronavirus infection is most likely. The system makes a conclusion about the degree of risk of the spread of the virus and, in case of danger, informs about the need for disinfection actions. The use of this system will reduce the cost of processing enclosed spaces, since it will not be carried out according to schedule, but in the case of a system signal. © 2021 IEEE.

8.
Nervenheilkunde ; 41(1-2):27-35, 2022.
Article in German | Scopus | ID: covidwho-1713246

ABSTRACT

Background Several studies report on the stress experiences by hospital employees during the COVID-19 pandemic, but also before the pandemic many medical hospital employees felt emotionally exhausted due to a high workload or unclear guidelines. Methods Cognitive appraisal and stress experiences of physicians from six hospitals during COVID-19 pandemic were assessed. Additionally, to the German-language version of the Stress Appraisal Measure (SAM), COVID-19 patient occupancy and relative bed occupancy were queried. Correlations in cross-sectional and longitudinal design were calculated. Results Participants t1: 170, t2: 55, t3: 47 physicians. Although there was no experience of such a pandemic, SAM averages were not noticeably different over time. Higher local new infections were not accompanied by an increased rating of the situation as threatening or stressful. High positive correlations of the same SAM sub-scales in the longitudinal design could be an indication of a time stable personality trait, which influences cognitive appraisal. Conclusion The results provide initial indications that medical staff had a good coping strategy with the stressful experiences caused by the pandemic. A more differentiated analysis of the stress experiences by medical staff in general, and not only at particular times of the pandemic, could be carried out in the future. © 2022 Georg Thieme Verlag. All rights reserved.

9.
Psychol Health ; : 1-18, 2022 Feb 14.
Article in English | MEDLINE | ID: covidwho-1684312

ABSTRACT

OBJECTIVE: This study applied the theory of reasoned goal pursuit (TRGP) in predicting physical activity among Australian undergraduate students, providing the first empirical test of the model.Methods: The research comprised an elicitation study (N = 25; MAge= 25.76, SDAge= 11.33, 20 female, 5 male) to identify readily accessible procurement and approval goal beliefs and behavioural, normative, and control beliefs; and, a two-wave prospective online survey study (N = 109; MAge = 21.88, SDAge = 7.04, 63 female, 46 male) to test the tenets of the TRGP in relation to meeting World Health Organization physical activity guidelines during the COVID-19 pandemic among first year university students.Results: A linear PLS-SEM model displayed good fit-to-data, predicting 38%, 74%, and 48% of the variance in motivation, intention, and physical activity, respectively. The model supported the majority of hypothesised pattern of effects among theory constructs; in particular, the proposition that beliefs corresponding to procurement and approval goals would be more consequential to people's motivation and, thus, their intentions and behaviour, than other behavioural and normative beliefs, respectively.Conclusions: Results lend support for the TRGP and sets the agenda for future research to systematically test the proposed direct, indirect, and moderation effects for different health behaviours, populations, and contexts.Supplemental data for this article is available online at https://doi.org/10.1080/08870446.2022.2026946 .

10.
Journal of Medical Ethics ; 47(9):648-648, 2021.
Article in English | Web of Science | ID: covidwho-1398720
SELECTION OF CITATIONS
SEARCH DETAIL