BackgroundTherapies to interrupt progression of early COVID-19 remain elusive. Among them, convalescent plasma in hospitalized patients was unsuccessful, perhaps because antibody should be administered earlier. We advanced plasma infusions to the first 72 hours of symptoms to arrest COVID-19 progression.MethodsA randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against SARS-CoV2 in elderly subjects within 72 hours of mild COVID-19 symptoms. The primary endpoint was severe respiratory disease defined as a respiratory rate ≥30 and/or an O2 sat<93% in room air. The study was interrupted at 76% of its projected sample size, because cases in the region decreased considerably and steady enrollment of study subjects became virtually impossible.Results160 patients underwent randomization. In the intention-to-treat analysis (ITT), 13/80(16.2%) patients receiving plasma vs. 25/80(31.2%) receiving placebo experienced severe respiratory disease [RR(95%CI)= 0.52(0.29,0.94); p=0.026)] with an RRR=48%.A modified ITT analysis, excluding six subjects who experienced the primary endpoint before infusion, showed a larger effect size [RR(95%CI) = 0.40(0.20, 0.81), p=0.007]. High- and low-titer donor analyses, based on a median IgG titer=1:3,200, evidenced a dose-dependent response with an RRR=73.3% for recipients of high-titer plasma (p=0.016) and a number needed to treat (NNT)=4.4. All secondary endpoints exhibited trends towards protection. No solicited adverse events were observed.ConclusionsEarly administration of high-titer convalescent plasma against SARS-CoV2 to mildly ill infected seniors reduced COVID-19 progression. This safe, inexpensive, outpatient intervention facilitates access to treatment from industrialized to LMIC, can decompress demands on hospitals, and may contribute to save lives.Funded by The Bill & Melinda Gates Foundation and The Fundación INFANT Pandemic Fund. Registered in the Dirección de Sangre y Medicina Transfusional del Ministerio de Salud (PAEPCC19), Plataforma PRIISA (1421), and clinicaltrials.gov (NCT04479163).All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organization for the submitted work; RL, GPM, DW and FPP are investigators in a phase 3 SARS CoV2 trial from Pfizer; no other relationships or activities that could appear to have influenced the submitted work.
SUMMARYThe majority (60 %) of the soils in the Venezuelan Andes are Inceptisols, a large percentage of which are classified as Dystrustepts by the US Soil Taxonomy, Second Edition of 1999. Some of these soils were classified as Humitropepts (high organic -C-OC-soils) and Dystropepts by the Soil Taxonomy prior to 1999, but no equivalent large group was created for high-OC soils in the new Ustepts suborder. Dystrusepts developed on different materials, relief and vegetation. Their properties are closely related with the parent material. Soils developed on transported deposits or sediments have darker and thicker A horizons, a slightly acid reaction, greater CEC and OC contents than upland slope soils. Based on the previous classification into large groups (Humitropepts and Dystropepts) we found that: Humitropepts have a slightly less acid and higher values of CEC than Dystropepts. These properties or characteristics seem to be related to the fact that Humitropepts have a higher clay and OC content than the Dystropepts. Canonical discrimination analysis showed that the variables that discriminate the two great soil groups from each other are OC and silt. Data for Humitropepts are grouped around the OC vector (defining axis 3, principal component analysis), while Dystropepts are associated with the clay and sand vectors, with significant correlation. Given the importance of OC for soil properties, we propose the creation of a new large group named Humustepts for the order Inceptisol, suborder Ustepts.
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