Evaluating the controlled reopening of nightlife during the COVID-19 pandemic : a matched cohort study in Sitges, Spain, in May 2021 (Reobrim Sitges)

To assess the impact of relaxing the state of alarm restrictions on SARS-CoV-2 infections at 14 days among people attending reopened nightclub venues. Matched cohort study with a paired control group (1:5 ratio). Five small nightclubs with indoor areas and outdoor terraces, in a nightlife-restricted area in Sitges, Spain, on 20 May 2021. Wearing masks was mandatory, drinking was allowed and social distance was not required. Volunteers were selected through a convenience sampling. To attend the event, participants were required to be older than 17 years, with a negative rapid antigen diagnostic test (Ag-RDT) on the same afternoon, without a positive reverse-transcription PCR (RT-PCR) or Ag-RDT and/or symptoms associated with COVID-19 in the previous 7 days, to not having knowingly been in close contact with someone infected in the previous 10 days and to not have knowingly had close contact with someone with a suspicion of COVID-19 in the previous 48 hours. A control group was paired by exact age, gender, residence municipality, socioeconomic index, previous SARS-CoV-2-confirmed infection and vaccination status, in a 1:5 ratio, from the primary care electronic health records. Evidence of infection at electronic health records by SARS-CoV-2 at 14-day follow-up. Among the 391 participants (median age 37 years; 44% (n=173) women), no positive SARS-CoV-2 cases were detected at 14 days, resulting in a cumulative incidence estimation of 0 (95% CI 0 to 943) per 100 000 inhabitants. In the control group, two cases with RT-PCR test were identified, resulting in a cumulative incidence of 102.30 (12.4 to 369) per 100 000 inhabitants. Nightlife attendance under controlled conditions and with a requirement for a negative Ag-RDT was not associated with increased transmissibility of SARS-CoV-2 in a pandemic context of low infection rates. In such circumstances, secure opening of the nightlife sector was possible, under reduced capacity and controlled access by Ag-RDT, and environments where compliance with sanitary measures are maintainable

Final Stage of Chronic Kidney Disease with Conservative Kidney Management or Renal Replacement Therapy: A Primary-Care Population Study

Background: Studies focus on the incidence and risk factors (RFs) associated with reaching the final stage of chronic kidney disease (CKD-G5) and receiving kidney replacement therapy (KRT). Analysis of those related to reaching CKD-G5 while receiving conservative kidney management (CKM) has been neglected. Methods: Retrospective cohort study analysing electronic health records of individuals aged & GE; 50 with eGFR < 60 mL/min/m(2). Cumulative incidence rates of CKD-G5, with and without KRT, were calculated. Multinomial regression models determined odds ratios (ORs) for CKD-G5 progression with KRT, CKM, or death. Results: Among 332,164 patients, the cumulative incidence of CKD-G5 was 2.79 cases per 100 person-years. The rates were 1.92 for CKD-G5 with KRT and 0.87 for CKD-G5 with CKM. Low eGFR and albuminuria were the primary RFs. Male gender and uncontrolled blood pressure had a greater impact on KRT (OR = 2.63 CI, 1.63) than on CKD-G5 with CKM (OR = 1.45 CI, 1.31). Increasing age and rurality reduced the probability of KRT but increased the probability of CKD-G5 with CKM. Higher incomes decreased the likelihood of developing CKD-G5 with and without KRT (OR = 0.49 CI). Conclusion: One-third of CKD-G5 cases receive CKM. Those are typically older, female, rural residents with lower incomes and with lesser proteinuria or cardiovascular RF. The likelihood of receiving KRT is influenced by location and socioeconomic disparities

Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

Background: The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable. Objectives: To evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality. Methods and analysis: Phase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast. Ethics and dissemination: This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals

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