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Rationale: Primary care clinicians may be well placed to play a greater role in obstructive sleep apnea management. Objectives: To evaluate the outcomes and cost-effectiveness of sleep apnea manage...

N-ethyl-pentylone (NEP), also known as "ephylone" and N-ethylnorpentylone, has been identified as one of the most recent novel psychostimulants to emerge into the illicit drug market and it has been associated with some intoxications and even fatalities. However, little is known about the consequences of its repeated consumption as well as the role of the monoaminergic system in such consequences. Thus, the aim of our study was to investigate the neurochemical profile and the behavioural effects after both acute and repeated NEP exposure. Male OF1 mice were acutely (1, 3, 10 mg/kg, i.p.) or repeatedly (1, 3, 10 mg/kg, i.p., 5 days, twice/day) exposed to NEP, and anxiety-like behaviour, aggressiveness, social interaction, depressive-like symptoms, body temperature, changes in monoaminergic enzymes and neurotransmitters levels as well as ΔFosB in striatum and prefrontal cortex (PFC) from post-mortem tissue were analysed short after drug-exposure or during drug-withdrawal. Acute administration of NEP induced anxiolytic effects but also an aggressive behaviour and social exploration deficits in mice, which persist during NEP-withdrawal. Moreover, NEP induced hyperthermia as well as depressive-like symptoms after repeated administrations that may be related to the decrease of serotonin and noradrenaline levels observed in striatum and PFC. Finally, the long-term increase in ΔFosB levels in striatum after NEP chronic exposure points to a high risk of dependence. Altogether indicates that NEP consumption induces different neurological and neuropsychiatric disorders accompanied by changes in the monoaminergic system, posing a threat to public health.

BACKGROUND Osteoarthritis is a disabling condition that is often associated with other comorbidities. Total hip or knee arthroplasty is an effective surgical treatment for osteoarthritis when indicated, but comorbidities can impair their results by increasing complications and social and economic costs. Integrated care (IC) models supported by eHealth can increase efficiency through defragmentation of care and promote patient-centeredness. OBJECTIVE This study aims to assess the effectiveness and cost-effectiveness of implementing a mobile health (mHealth)–enabled IC model for complex chronic patients undergoing primary total hip or knee arthroplasty. METHODS As part of the Horizon 2020 Personalized Connected Care for Complex Chronic Patients (CONNECARE) project, a prospective, pragmatic, two-arm, parallel implementation trial was conducted in the rural region of Lleida, Catalonia, Spain. For 3 months, complex chronic patients undergoing total hip or knee arthroplasty and their caregivers received the combined benefits of the CONNECARE organizational IC model and the eHealth platform supporting it, consisting of a patient self-management app, a set of integrated sensors, and a web-based platform connecting professionals from different settings, or usual care (UC). We assessed changes in health status (12-item short-form survey [SF-12]), unplanned visits and admissions during a 6-month follow-up, and the incremental cost-effectiveness ratio. RESULTS A total of 29 patients were recruited for the mHealth-enabled IC arm, and 30 patients were recruited for the UC arm. Both groups were statistically comparable for baseline characteristics, such as age; sex; type of arthroplasty; and Charlson index, American Society of Anesthesiologists classification, Barthel index, Hospital Anxiety and Depression scale, Western Ontario and McMaster Universities Osteoarthritis Index, and Pfeiffer mental status questionnaire scores. Patients in both groups had significant increases in the SF-12 physical domain and total SF-12 score, but differences in differences between the groups were not statistically significant. IC patients had 50% fewer unplanned visits (P=.006). Only 1 hospital admission was recorded during the follow-up (UC arm). The IC program generated savings in different cost scenarios, and the incremental cost-effectiveness ratio demonstrated cost-effectiveness. CONCLUSIONS Chronic patients undergoing hip or knee arthroplasty can benefit from the implementation of patient-centered mHealth-enabled IC models aimed at empowering patients and facilitating transitions from specialized hospital care to primary care. Such models can reduce unplanned contacts with the health system and reduce overall health costs, proving to be cost-effective. Overall, our findings support the notion of system-wide cross-organizational care pathways supported by mHealth as a successful way to implement IC for patients undergoing elective surgery.

Background Integrated care can generate health and social care efficiencies through the defragmentation of care and adoption of patient-centered preventive models. eHealth can be a key enabling technology for integrated care. Objective The aim of this study was to assess the effectiveness and cost-effectiveness of the implementation of a mobile health (mHealth)-enabled integrated care model for complex chronic patients. Methods As part of the CONNECARE Horizon 2020 project, a prospective, pragmatic, two-arm, parallel implementation trial was held in a rural region of Catalonia, Spain. During 3 months, elderly patients with chronic obstructive pulmonary disease or heart failure and their carers experienced the combined benefits of the CONNECARE organizational integrated care model and the eHealth platform supporting it, consisting of a patient self-management app, a set of integrated sensors, and a web-based platform connecting professionals from different settings, or usual care. We assessed changes in health status with the 12-Item Short-Form Survey (SF-12), unplanned visits and admissions during a 6-month follow up, and the incremental cost-effectiveness ratio (ICER). Results A total of 48 patients were included in the integrated care arm and 28 patients receiving usual care were included in the control arm (mean age 82 years, SD 7 years; mean Charlson index 7, SD 2). Integrated care patients showed a significant increase in the SF-12 physical domain with a mean change of +3.7 (SD 8.4) (P=.004) and total SF-12 score with a mean change of +5.8 (SD 12.8) (P=.003); however, the differences in differences between groups were not statistically significant. Integrated care patients had 57% less unplanned visits (P=.004) and 50% less hospital admissions related to their main chronic diseases (P=.32). The integrated care program generated savings in different cost scenarios and the ICER demonstrated the cost-effectiveness of the program. Conclusions The implementation of a patient-centered mHealth-enabled integrated care model empowering the patient, and connecting primary, hospital, and social care professionals reduced unplanned contacts with the health system and health costs, and was cost-effective. These findings support the notion of system-wide cross-organizational care pathways supported by mHealth as a successful way to implement integrated care.

BACKGROUND Integrated care (IC) can promote health and social care efficiency through prioritization of preventive patient-centered models and defragmentation of care and collaboration across health tiers, and mobile health (mHealth) can be the cornerstone allowing for the adoption of IC. OBJECTIVE This study aims to assess the acceptability, usability, and satisfaction of an mHealth-enabled IC model for complex chronic patients in both patients and health professionals. METHODS As part of the CONNECARE Horizon 2020 project, a prospective, pragmatic, 2-arm, parallel, hybrid effectiveness-implementation trial was conducted from July 2018 to August 2019 in a rural region of Catalonia, Spain. Home-dwelling patients 55 years and older with chronic conditions and a history of hospitalizations for chronic obstructive pulmonary disease or heart failure (use case [UC] 1), or a scheduled major elective hip or knee arthroplasty (UC2) were recruited. During the 3 months, patients experienced an mHealth-enabled IC model, including a self-management app for patients, a set of integrated sensors, and a web-based platform connecting professionals from different settings or usual care. The Person-Centered Coordinated Care Experience Questionnaire (P3CEQ) and the Nijmegen Continuity Questionnaire (NCQ) assessed person-centeredness and continuity of care. Acceptability was assessed for IC arm patients and staff with the Net Promoter Score (NPS) and the System Usability Scale (SUS). RESULTS The analyses included 77 IC patients, 58 controls who completed the follow-up, and 30 health care professionals. The mean age was 78 (SD 9) years in both study arms. Perception of patient-centeredness was similarly high in both arms (usual care: mean P3CEQ score 16.1, SD 3.3; IC: mean P3CEQ score 16.3, SD 2.4). IC patients reported better continuity of care than controls (usual care: mean NCQ score 3.7, SD 0.9; IC: mean NCQ score 4.0, SD 1; P=.04). The scores for patient acceptability (UC1: NPS +67%; UC2: NPS +45%) and usability (UC1: mean SUS score 79, SD 14; UC2: mean SUS score 68, SD 24) were outstanding. Professionals’ acceptability was low (UC1: NPS −25%; UC2: NPS −35%), whereas usability was average (UC1: mean SUS score 63, SD 20; UC2: mean SUS score 62, SD 19). The actual use of technology was high; 77% (58/75) of patients reported physical activity for at least 60 days, and the ratio of times reported over times prescribed for other sensors ranged from 37% for oxygen saturation to 67% for weight. CONCLUSIONS The mHealth-enabled IC model showed outstanding results from the patients’ perspective in 2 different UCs but lacked maturity and integration with legacy systems to be fully accepted by professionals. This paper provides useful lessons learned through the development and assessment process and may be of use to organizations willing to develop or implement mHealth-enabled IC for older adults.

BACKGROUND Integrated care can generate health and social care efficiencies through the defragmentation of care and adoption of patient-centered preventive models. eHealth can be a key enabling technology for integrated care. OBJECTIVE The aim of this study was to assess the effectiveness and cost-effectiveness of the implementation of a mobile health (mHealth)-enabled integrated care model for complex chronic patients. METHODS As part of the CONNECARE Horizon 2020 project, a prospective, pragmatic, two-arm, parallel implementation trial was held in a rural region of Catalonia, Spain. During 3 months, elderly patients with chronic obstructive pulmonary disease or heart failure and their carers experienced the combined benefits of the CONNECARE organizational integrated care model and the eHealth platform supporting it, consisting of a patient self-management app, a set of integrated sensors, and a web-based platform connecting professionals from different settings, or usual care. We assessed changes in health status with the 12-Item Short-Form Survey (SF-12), unplanned visits and admissions during a 6-month follow up, and the incremental cost-effectiveness ratio (ICER). RESULTS A total of 48 patients were included in the integrated care arm and 28 patients receiving usual care were included in the control arm (mean age 82 years, SD 7 years; mean Charlson index 7, SD 2). Integrated care patients showed a significant increase in the SF-12 physical domain with a mean change of +3.7 (SD 8.4) (P=.004) and total SF-12 score with a mean change of +5.8 (SD 12.8) (P=.003); however, the differences in differences between groups were not statistically significant. Integrated care patients had 57% less unplanned visits (P=.004) and 50% less hospital admissions related to their main chronic diseases (P=.32). The integrated care program generated savings in different cost scenarios and the ICER demonstrated the cost-effectiveness of the program. CONCLUSIONS The implementation of a patient-centered mHealth-enabled integrated care model empowering the patient, and connecting primary, hospital, and social care professionals reduced unplanned contacts with the health system and health costs, and was cost-effective. These findings support the notion of system-wide cross-organizational care pathways supported by mHealth as a successful way to implement integrated care.

The emergence of new synthetic cathinones continues to be a matter of public health concern. In fact, they are quickly replaced by new structurally related alternatives. The main goal of the present study was to characterize the pharmacological profile, the psychostimulant and rewarding properties of novel cathinones (pentedrone, N-ethyl-pentedrone, α-PVP, N,N-diethyl-pentedrone and α-PpVP) which only differs in their amino terminal substitution. Rat synaptosomes were used for [3H]dopamine uptake experiments. HEK293 transfected cells (hDAT, hSERT, hOCT; human dopamine, serotonin and organic cation transporter) were also used for [3H]monoamine uptake and transporter binding assays. Molecular docking was used to investigate the effect of the amino substitutions on the biological activity. Hyperlocomotion and conditioned place preference paradigm were used in order to study the psychostimulant and rewarding effects in mice. All compounds tested are potent inhibitors of DAT with very low affinity for SERT, hOCT-2 and -3, and their potency for inhibiting DAT increased when the amino-substituent expanded from a methyl to either an ethyl-, a pyrrolidine- or a piperidine-ring. Regarding the in vivo results, all the compounds induced an increase in locomotor activity and possess rewarding properties. Results also showed a significant correlation between predicted binding affinities by molecular docking and affinity constants (Ki) for hDAT as well as the cLogP of their amino-substituent with their hDAT/hSERT ratios. Our study demonstrates the role of the amino-substituent in the pharmacological profile of novel synthetic cathinones as well as their potency inhibiting DA uptake and ability to induce psychostimulant and rewarding effects in mice.

ObjectiveTo assess the effectiveness and cost-effectiveness of primary care (PC) and sleep unit (SU) models for the management of subjects with suspected obstructive sleep apnoea (OSA).MethodsMulticentre, open-label, two-arm, parallel-group, non-inferiority randomised controlled trial. A total of 302 subjects with suspected OSA and/or resistant hypertension were consecutively enrolled, 149 were treated at 11 PC units and 153 patients at a SU. The primary outcomes were a 6-month change in the Epworth Sleepiness Scale (ESS) score and Health Utilities Index (HUI). The non-inferiority margin for the ESS score was −2.0.ResultsA total of 80.2% and 70.6% of the PC and SU patients were diagnosed with OSA, respectively, and 59.3% and 60.4% of those were treated with CPAP in PC and SU units, respectively. The Apnoea–Hypopnoea Index was similar between the groups (PC vs SU (median (IQR); 23.1 (26.8) events/h vs 21.8 (35.2) events/h), and the baseline ESS score was higher in the PC than in the SU group (10.3 (6.6) vs 9 (7.2)). After 6 months, the ESS score of the PC group decreased from a mean of 10.1 to 7.6 (−2.49; 95% CI −3.3 to −1.69), and that of the SU group decreased from 8.85 to 5.73 (−3.11; 95% CI −3.94 to 2.28). The adjusted difference between groups for the mean change in the ESS score was −1.25 (one-sided 95% CI −1.88; p=0.025), supporting the non-inferiority of PC management. We did not observe differences in the HUI between groups. The cost analysis showed a median savings of €558.14/patient for the PC setting compared with the SU setting.ConclusionsAmong patients with suspected OSA, the PC model did not result in a worse ESS score or HUI than the specialist model and generated savings in terms of management cost. Therefore, the PC model was more cost-efficient than the SU model.Trial registrationResults; >>NCT02234765, Clinical Trials.gov.

Purpose – The purpose of this paper is to present new aspects of the tension between creativity and productivity and improve the understanding on how research can be developed in very restricted environments, such as the context of an organization managed using the methods of Project Management. And more generally, it introduces the rhetoric of judgment as a fundamental aspect involved in the development and specification of projects. Design/methodology/approach – The theoretical approach is based on the phenomenological theory of human intentional action developed by Alfred Schutz, in which the notion of mental project is more flexible than that of project management. In it the concepts of subaction and repeated action are considered a combination of similar actions already performed. The Kantian notion of judgment is introduced to outline self-persuasion as a fundamental source of creativity. Findings – The introduction of an extended notion of project and routine involving judgment expands the rational, generic and technical notion of project management. And the rhetorical aspect of judgment, at the individual level, establishes the possibility to deliver unexpected outcomes that are considered creative. Originality/value – The proposed notions of project and routines mediated through the rhetoric of judgment present theoretical and practical progress in the subject of managing projects.

Background Integrated care (IC) can promote health and social care efficiency through prioritization of preventive patient-centered models and defragmentation of care and collaboration across health tiers, and mobile health (mHealth) can be the cornerstone allowing for the adoption of IC. Objective This study aims to assess the acceptability, usability, and satisfaction of an mHealth-enabled IC model for complex chronic patients in both patients and health professionals. Methods As part of the CONNECARE Horizon 2020 project, a prospective, pragmatic, 2-arm, parallel, hybrid effectiveness-implementation trial was conducted from July 2018 to August 2019 in a rural region of Catalonia, Spain. Home-dwelling patients 55 years and older with chronic conditions and a history of hospitalizations for chronic obstructive pulmonary disease or heart failure (use case [UC] 1), or a scheduled major elective hip or knee arthroplasty (UC2) were recruited. During the 3 months, patients experienced an mHealth-enabled IC model, including a self-management app for patients, a set of integrated sensors, and a web-based platform connecting professionals from different settings or usual care. The Person-Centered Coordinated Care Experience Questionnaire (P3CEQ) and the Nijmegen Continuity Questionnaire (NCQ) assessed person-centeredness and continuity of care. Acceptability was assessed for IC arm patients and staff with the Net Promoter Score (NPS) and the System Usability Scale (SUS). Results The analyses included 77 IC patients, 58 controls who completed the follow-up, and 30 health care professionals. The mean age was 78 (SD 9) years in both study arms. Perception of patient-centeredness was similarly high in both arms (usual care: mean P3CEQ score 16.1, SD 3.3; IC: mean P3CEQ score 16.3, SD 2.4). IC patients reported better continuity of care than controls (usual care: mean NCQ score 3.7, SD 0.9; IC: mean NCQ score 4.0, SD 1; P=.04). The scores for patient acceptability (UC1: NPS +67%; UC2: NPS +45%) and usability (UC1: mean SUS score 79, SD 14; UC2: mean SUS score 68, SD 24) were outstanding. Professionals’ acceptability was low (UC1: NPS −25%; UC2: NPS −35%), whereas usability was average (UC1: mean SUS score 63, SD 20; UC2: mean SUS score 62, SD 19). The actual use of technology was high; 77% (58/75) of patients reported physical activity for at least 60 days, and the ratio of times reported over times prescribed for other sensors ranged from 37% for oxygen saturation to 67% for weight. Conclusions The mHealth-enabled IC model showed outstanding results from the patients’ perspective in 2 different UCs but lacked maturity and integration with legacy systems to be fully accepted by professionals. This paper provides useful lessons learned through the development and assessment process and may be of use to organizations willing to develop or implement mHealth-enabled IC for older adults.

Background Good adherence to continuous positive airway pressure (CPAP) treatment improves the patient's quality of life and decreases the risk of cardiovascular disease. Previous studies that have analyzed the adherence to CPAP were performed in a sleep unit (SU) setting. The involvement of primary care (PC) in the management of obstructive sleep apnea (OSA) patients receiving CPAP treatment could introduce factors related to the adherence to treatment. Objectives The objective was to compare the baseline predictors of CPAP compliance in SU and PC settings. Methods OSA patients treated with CPAP were followed for 6 months in SU or PC setting. We included baseline clinical and anthropometrical variables, the Epworth Sleep Scale (ESS) score, the quality of life index, and the Charlson index. A logistic regression was performed for each group to determine the CPAP compliance predictors. Discrimination and calibration were performed using the area under the curve and Hosmer-Lemeshow tests. Results We included 191 patients: 91 in the PC group and 100 in the SU group. In 74.9% of the patients, the compliance was ≥ 4 h per day, with 80% compliance in the SU setting and 69.2% compliance in the PC setting (p = 0.087). The predictors of CPAP compliance were different between SU and PC settings. Body mass index, ESS, and CPAP pressure were predictors in the SU setting, and ESS, gender, and waist circumference were predictors in the PC setting. Conclusions The predictors of adequate CPAP compliance vary between SU and PC settings. Detecting compliance predictors could help in the planning of early interventions to improve CPAP adherence.

Purpose – The purpose of this paper is to identify different types of project in relation to their degree of specification and the creative possibilities that more highly specified projects offer researchers. Design/methodology/approach – This paper presents the limitations of project management methods when managing research in relation to creativity. If projects are rigorously formulated and fulfill the requirements of project management, they may be compared to a mechanical task in which active decision making no longer applies. The conceptual framework develops the study of the spaces of creativity that research projects offer based on intentional action in which the notion of project is considered to be more flexible than that of more traditional approaches, and the notion of judgment is seen as a source of creativity. The empirical research presents the study of two scientific projects and compares their degree of the goal and task specification, the time required to specify them and how creativity emerges from routinized activities. Findings – The spaces of creative possibilities in projects are related in two ways: first, these spaces are related to a critical view of the concepts of repeated action and routines, and second, they are related to the ways researchers use projects and the methods of project management not only as a method but also as a form of rhetoric. Originality/value – Constituting a contribution to organizational change and innovation theory that enlarges the concept of project and brings understanding of how researchers define their projects, confront project specifications and are creative in a constrained framework.

BACKGROUND Obstructive sleep apnea syndrome (OSA) is a chronic sleep disorder characterized by repeated episodes of upper airway collapse during sleep. This leads to arterial hypoxemia and sleep disruption and causes daytime sleepiness and several associated dysfunctions, including cardiovascular, respiratory, metabolic, inflammatory, cognitive, and behavioral disorders.(1) OSA is a relevant public health issue, with epidemiological studies showing a prevalence of 10% in middle-aged men and 3% in middle-aged women.(2) Moreover, OSA has been associated with the development of cardiovascular events(3,4) and resistant hypertension,(5) has a negative impact on quality of life,(6) and has even been shown to have a causative role in traffic accidents.(7) The application of continuous positive airway pressure (CPAP) is a highly effective treatment for OSA that can improve symptoms and quality of life, decrease traffic accidents and potentially lessen cardiovascular morbidity.(8,9) Furthermore, CPAP is cost-effective.(10) However, only approximately 10% of individuals with OSA are diagnosed and treated. This scarcity in diagnosis has direct public health consequences due to the above-mentioned health implications and the high economic costs associated with untreated OSA. Currently, the diagnosis and management of OSA are performed in highly specialized hospital-based sleep units (SUs), where full sleep studies (polysomnography (PSG)) or respiratory poligraphy (RP) can be conducted. However, this management approach has proven to be insufficient in identifying most OSA cases in the population, in addition to being cost-ineffective and generating long waiting lists.(11) Given that OSA is a common chronic disorder, we believe that all levels of a healthcare system, especially primary care (PC), should be included in its management.(12-14) The first trials assessing the management of OSA at the PC level reported satisfactory results.(15-19) Moreover, our group showed that CPAP compliance did not differ between the PC and SU setting and was more cost-effective in the PC setting. 19 However, in the above studies, although OSA management occurred at the PC level, diagnosis had always occurred in a SU. Therefore, in the current study, we aimed to determine the efficacy and cost-effectiveness of implementing a program for the diagnosis and management of OSA that can be conducted by PC personnel, and we compared these outcomes to those generated using the standard diagnosis and management protocols that are practiced in SUs. AIMS The main objectives of the GESAP study are to assess the efficacies of PC and SU programs for OSA management. These assessments will be made using the Epworth sleepiness scale (ESS) before and for 6 months after initiating the program to assess its cost-effectiveness based on both ESS and quality of life (EuroQol-5D). Secondary objectives include assessments of patient satisfaction, treatment compliance, and the number, severity, and evolution of the treatment's side effects. Fondo de Investigación Sanitaria (PI 13/02004), Fondo Europeo de Desarrollo Regional (FEDER), Una manera de hacer Europa; the Spanish Respiratory Society (SEPAR); and Esteve-Teijin (Spain). Cofunded by Ministerio de Economía y Competitividad [COFUND2014-51501]. The authors would like to thank all PC personnel involved in the study, as well as the kind support from Maricel Arbonés, Olga Mínguez and Lídia Pascual (Group of Translational Research in Respiratory Medicine, IRB Lleida, Spain).

We developed two virtual communities of practice (Endobloc and Pneumobloc) to increase the interaction between general practitioners and nurses in primary care and hospital endocrinologists and pulmonologists. They were designed and developed using an existing web 2.0-based virtual network belonging to the local National Health System, and we quantitatively assessed the usefulness through the participation and use during the first 24 months after the launch in 2010. A total of 26,372 visits (47% Endobloc’s visits) and 2351 contributions (Endobloc’s contribution 38.9%) to both virtual communities of practice were registered during the first 24 months. The most popular sections were the e-Blog and the e-Consultations section in both virtual communities of practice, but some differences in the pattern of use in other sections were observed. Activity on the virtual communities of practice occurred throughout the day including weekends and holiday periods. We showed that virtual communities of practice are feasible under real-life clinical practice.

Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. registry: . 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. .