Functional Autonomy Evaluation Levels in Middle-Aged and Older Spanish Women: On Behalf of the Healthy-Age Network

Aging is associated with a progressive loss of functional capacity that affects the health and quality of life of middle-aged and older people. The purpose of this study was to report functional autonomy evaluation levels in middle-aged and older women in the Spanish context. A total of 709 middle-aged and older women, between 50 and 90 years old, were selected to participate in the study. The sample was divided by age category every five years. The functional autonomy levels were determined by the Latin American Group for Maturity (GDLAM) protocol and we developed a classification pattern for middle-aged and older women living in Spain. The GDLAM Index (GI) was then calculated to assess functional autonomy. The classification of the tests and the GI followed the percentile rank (P) Very Good (p 0.85). It was considered that the lower the value found for the percentile, the better the result. The GDLAM protocol showed strong reliability with intraclass correlation coefficient (ICC) values greater than 0.92 in all tests. It is observed that all variables of the GDLAM protocol presented a positive and significant correlation with age (p < 0.001). The Roc Curve showed that GI values higher than 26 (CI95% = 0.97-1.00; p < 0.001) and 32 (CI95% = 0.98-1.00; p < 0.001) for middle-aged and elderly women, respectively, can predict and indicate low functional autonomy. The normative values hereby provided will enable evaluation and adequate interpretation of Spanish middle-aged and older women's functional autonomy

Prehistoria, frontera del conocimiento: Homenaje a L. Gerardo Vega Toscano

Prehistoria, frontera del conocimiento: Homenaje a L. Gerardo Vega Toscan

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

Summary: Background: 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. Methods: 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. ClinicalTrials.gov registry: NCT04847141. Findings: 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. Interpretation: 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. Funding: Grifols