Background With the lack of effective therapy, chemoprevention, and vaccination against SARS-CoV-2, focusing on the immediate repurposing of existing drugs gives hope of curbing the COVID-19 pandemic. A recent unbiased genomics-guided tracing of the SARS-CoV-2 targets in human cells identified vitamin D among the three top-scoring molecules manifesting potential infection mitigation patterns. Growing pre-clinical and epidemiological observational data support this assumption. We hypothesized that vitamin D supplementation may improve the prognosis of COVID-19. The aim of this trial is to compare the effect of a single oral high dose of cholecalciferol versus a single oral standard dose on all-cause 14-day mortality rate in COVID-19 older adults at higher risk of worsening. Methods The COVIT-TRIAL study is an open-label, multicenter, randomized controlled superiority trial. Patients aged ≥ 65 years with COVID-19 (diagnosed within the preceding 3 days with RT-PCR and/or chest CT scan) and at least one worsening risk factor at the time of inclusion (i.e., age ≥ 75 years, or SpO2 ≤ 94% in room air, or PaO2/FiO2 ≤ 300 mmHg), having no contraindications to vitamin D supplementation, and having received no vitamin D supplementation > 800 IU/day during the preceding month are recruited. Participants are randomized either to high-dose cholecalciferol (two 200,000 IU drinking vials at once on the day of inclusion) or to standard-dose cholecalciferol (one 50,000 IU drinking vial on the day of inclusion). Two hundred sixty participants are recruited and followed up for 28 days. The primary outcome measure is all-cause mortality within 14 days of inclusion. Secondary outcomes are the score changes on the World Health Organization Ordinal Scale for Clinical Improvement (OSCI) scale for COVID-19, and the between-group comparison of safety. These outcomes are assessed at baseline, day 14, and day 28, together with the serum concentrations of 25(OH)D, creatinine, calcium, and albumin at baseline and day 7. Discussion COVIT-TRIAL is to our knowledge the first randomized controlled trial testing the effect of vitamin D supplementation on the prognosis of COVID-19 in high-risk older patients. High-dose vitamin D supplementation may be an effective, well-tolerated, and easily and immediately accessible treatment for COVID-19, the incidence of which increases dramatically and for which there are currently no scientifically validated treatments. Trial registration ClinicalTrials.govNCT04344041. Registered on 14 April 2020 Trial status Recruiting. Recruitment is expected to be completed in April 2021.

Background Humoral response against SARS-CoV-2 after two doses of BNT162b2 (Pfizer-BioNTech) has been proven less intense in maintenance dialysis patients as compared to healthy subjects, leading the French authorities to recommend a third injection in this population. Here, we investigated the response to the third injection in two cohorts of hemodialysis patients. Methods Data from two prospective observational cohorts were collected. In the first -“systematic”- cohort, patients from 2 hemodialysis centers (n = 66) received a 3rd injection of BNT162b2, regardless of the response after two injections. In the second -“conditional”- cohort, the injection was only prescribed to patients (n = 34) with no or low response to the previous two doses. In both cohorts, the 3rd dose was injected 1 to 2 months after the 2nd dose. Serology was performed after the 2nd and 3rd dose to assess anti-Spike IgG antibody titer. Results In the “systematic” cohort, anti-Spike IgG were found in 83.3% and 92.4% of patients after the 2nd and the 3rd dose of BNT162b2, respectively. In this cohort, 6/11 (54.5%) and 20/21 (95.2%) patients switched from non-responder to low-responder and from low-responder to high-responder, respectively. In low and high-responders to 2 doses, 50/55 (90.9%) at least doubled their anti-Spike IgG titer. Similar trends were observed in the “conditional” cohort. Conclusions In maintenance hemodialysis patients, humoral response against SARS-Cov-2 was boosted after a third dose of BNT162b2, allowing seroconversion in more than half of non-responders. These data may support an intensified vaccination protocol with a 3rd dose of BNT162b2 in dialysis patients.

Background The objective of this cohort study was to determine whether elevated CRP in early COVID-19 was associated with 14-day mortality in geriatric patients. Methods Plasma CRP levels at hospital admission and 14-day all-cause mortality were assessed in geriatric inpatients hospitalized for COVID-19. Potential confounders were age, sex, functional abilities, history of malignancies, hypertension, cardiomyopathy, albuminemia, number of acute health issues, use of antibiotics and respiratory treatments. Results Ninety-five participants (mean±SD 88.0±5.5years; 49.5%women; mean CRP, 76.7±77.5mg/L; mean albuminemia, 32.9±6.0g/L) were included. Sixteen participants who did not survive at day 14 exhibited higher CRP level at baseline than the others (120.3±71.2 versus 67.9±76.1 mg/L, P = 0.002). There was no difference in albuminemia (P = 0.329). Plasma CRP level was directly associated with 14-day mortality (fully adjusted HR = 1.11, P = 0.025). The cut-off for CRP associated with 14-day mortality was set at 35mg/L (sensitivity = 0.88; specificity = 0.56). Those with CRP<35mg/L had longer survival time than the others (log-rank P<0.001). Conclusions Elevated CRP levels were associated with poorer 14-day survival in hospitalized geriatric COVID-19 patients.

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