Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).
for the ConPlas-19 Study Group* *Complete list of the ConPlas-19 study group provided in the Supplement.
The great amount of nitric oxide (NO) produced by the inducible isoform of NO synthase (iNOS) exerts deleterious effects, and iNOS expression is raised in the colonic mucosa of inflammatory bowel disease (IBD) patients. This is the first association analysis of polymorphisms within the NOS2A extended gene with IBD susceptibility. We analyzed 336 patients of Crohn's disease (CD), 355 of ulcerative colitis (UC), and 536 healthy controls from a Spanish population. We tested a (CCTTT)n microsatellite, a (-/TAAA) insertion, and two single nucleotide polymorphisms (SNPs) flanking them (rs2779251 and rs2779248) in the NOS2A promoter, together with two SNPs in the coding region: one within exon 10, D385D (rs1137933), and another mapping to exon 16, S608L (rs2297518). Analysis of these markers evidenced differences among IBD patients and healthy controls. Allele (CCTTT) 13 is related to higher UC risk (p = 0.001; odds ratio [OR] [95% confidence interval, CI] = 1.64 [1.20-2.23]). Carriers of minor alleles of the two promoter SNPs analyzed showed an association with UC predisposition, and common allele homozygotes of the two exonic SNPs were more frequent among CD patients than among controls. Concordantly, one out of the three haplotypes carrying both exonic risk alleles was found to increase CD susceptibility (p = 0.007; OR [95%CI] = 1.74 [1.13-2.67]). Therefore, the NOS2A gene seems to be involved in IBD aetiology.
We found that female sex, colonic involvement, and the AA genotype at -110 G>A were associated with increased risk of both subtypes of PA, although the association appears to be stronger for arthritis than for arthralgia.
BackgroundSeroprevalence analysis of SARS-CoV-2 is one of the keys to accurately monitor pandemics and help the authorities make health decisions and adjust the current social interventions. The aim of this study was to determine retrospective seroprevalence evolution among blood donors along prepandemic months, and the first wave in Spain. A secondary objective was to determine whether age, blood group or haematological parameters are related to recent past infection.Material and MethodsA total of 12719 donations SARS-CoV-2 from July 2019 to October 2020 were analysed. Donors were 60.9% males and their average age was 46+/-13. An automated chemiluminiscence double-antigen sandwich immunoassay for the in vitro semi quantitative detection of total antibodies to SARS-CoV-2 in human serum and plasma was performed.ResultsSeropositivity donation rate grew up from week 11 to week 21, reaching plateau by near 8% donations, sustained until week 43 when 2nd wave arose in our country. 6.7% individuals were positive by the end of 1st wave. No differences by sex age or blood group were found regarding antibodies. Lymphocyte were significantly higher in positive woman as compared to negative ones and haemoglobin were lower in positive men as compared to negative ones.DiscussionSeroprevalence due to asymptomatic cases would be equivalent to that of general population. Sex and age would not affect COVID-19 susceptibility but its severity. Gender differences are present even in asymptomatic individuals: females are possibly protected by their relative lymphocytosis and neutropenia whereas males are would be weaker as seropositive men show a decrease of haematocrit and haemoglobin. Further studies are needed to confirm these gender differences not only in severe but as well in asymptomatic cases as they can help better understand COVID19 pathogenesis and prognosis.
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