Creation of a Laboratory for Statistics and Analysis of Dependence and Chronic Conditions: Protocol for the Bages Territorial Specialization and Competitiveness Project (PECT BAGESS).

BACKGROUND: With the increasing prevalence of chronic diseases, partly due to the increase in life expectancy and the aging of the population, the complexity of the approach faced by the structures, dynamics, and actors that are part of the current care and attention systems is evident. The territory of Bages (Catalonia, Spain) presents characteristics of a highly complex ecosystem where there is a need to develop new, more dynamic structures for the various actors in the health and social systems, aimed at incorporating new actors in the technological and business field that would allow innovation in the management of this context. Within the framework of the Bages Territorial Specialization and Competitiveness Project (PECT BAGESS), the aim is to address these challenges through various entities that will develop 7 interrelated operations. Of these, the operation of the IDIAP Jordi Gol-Catalan Health Institute focuses on the creation of a Laboratory for Statistics and Analysis of Dependence and Chronic Conditions in the Bages region, in the form of a database that will collect the most relevant information from the different environments that affect the management of chronic conditions and dependence: health, social, economic, and environment. OBJECTIVE: This study aims to create a laboratory for statistical, dependence, and chronic condition analysis in the Bages region, to determine the chronic conditions and conditions that generate dependence in the Bages area, in order to propose products and services that respond to the needs of people in these situations. METHODS: PECT BAGESS originated from the Shared Agenda initiative, which was established in the Bages region with the goal of enhancing the quality of life and fostering social inclusion for individuals with chronic diseases. This study presents part of this broader project, consisting of the creation of a database. Data from chronic conditions and dependence service providers will be combined, using a unique identifier for the different sources of information. A thorough legal analysis was conducted to establish a secure data sharing mechanism among the entities participating in the project. RESULTS: The laboratory will be a key piece in the structure generated in the environment of the PECT BAGESS, which will allow relevant information to be passed on from the different sectors involved to respond to the needs of people with chronic conditions and dependence, as well as to generate opportunities for products and services. CONCLUSIONS: The emerging organizational dynamics and structures are expected to demonstrate a health and social management model that may have a remarkable impact on these sectors. Products and services developed may be very useful for generating synergies and facilitating the living conditions of people who can benefit from all these services. However, secure data sharing circuits must be considered. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46542.

Persistence and baseline determinants of seropositivity and reinfection rates in health care workers up to 12.5 months after COVID-19.

We assessed the duration and baseline determinants of antibody responses to SARS-CoV-2 spike antigens and the occurrence of reinfections in a prospective cohort of 173 Spanish primary health care worker patients followed initially for 9 months and subsequently up to 12.5 months after COVID-19 symptoms onset. Seropositivity to SARS-CoV-2 spike and receptor-binding domain antigens up to 149-270 days was 92.49% (90.17% IgG, 76.3% IgA, 60.69% IgM). In a subset of 64 health care workers who had not yet been vaccinated by April 2021, seropositivity was 96.88% (95.31% IgG, 82.81% IgA) up to 322-379 days post symptoms onset. Four suspected reinfections were detected by passive case detection, two among seronegative individuals (5 and 7 months after the first episode), and one low antibody responder. Antibody levels significantly correlated with fever, hospitalization, anosmia/hypogeusia, allergies, smoking, and occupation. Stable sustainment of IgG responses raises hope for long-lasting COVID-19 vaccine immunity.

Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial.

BACKGROUND: No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19. METHODS: Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with <5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days. RESULTS: A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (-1.41 vs -1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (-3.37 vs -3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported. CONCLUSIONS: In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.

A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19.

BACKGROUND: Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are limited to nonpharmacologic interventions. Hydroxychloroquine has been proposed as a postexposure therapy to prevent coronavirus disease 2019 (Covid-19), but definitive evidence is lacking. METHODS: We conducted an open-label, cluster-randomized trial involving asymptomatic contacts of patients with polymerase-chain-reaction (PCR)-confirmed Covid-19 in Catalonia, Spain. We randomly assigned clusters of contacts to the hydroxychloroquine group (which received the drug at a dose of 800 mg once, followed by 400 mg daily for 6 days) or to the usual-care group (which received no specific therapy). The primary outcome was PCR-confirmed, symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, defined by symptoms compatible with Covid-19 or a positive PCR test regardless of symptoms. Adverse events were assessed for up to 28 days. RESULTS: The analysis included 2314 healthy contacts of 672 index case patients with Covid-19 who were identified between March 17 and April 28, 2020. A total of 1116 contacts were randomly assigned to receive hydroxychloroquine and 1198 to receive usual care. Results were similar in the hydroxychloroquine and usual-care groups with respect to the incidence of PCR-confirmed, symptomatic Covid-19 (5.7% and 6.2%, respectively; risk ratio, 0.86 [95% confidence interval, 0.52 to 1.42]). In addition, hydroxychloroquine was not associated with a lower incidence of SARS-CoV-2 transmission than usual care (18.7% and 17.8%, respectively). The incidence of adverse events was higher in the hydroxychloroquine group than in the usual-care group (56.1% vs. 5.9%), but no treatment-related serious adverse events were reported. CONCLUSIONS: Postexposure therapy with hydroxychloroquine did not prevent SARS-CoV-2 infection or symptomatic Covid-19 in healthy persons exposed to a PCR-positive case patient. (Funded by the crowdfunding campaign YoMeCorono and others; BCN-PEP-CoV2 ClinicalTrials.gov number, NCT04304053.).