ABSTRACT
Background: The efficacy of COVID-19 convalescent plasma (CCP) as passive immunotherapy in hospitalized COVID-19 patients remains uncertain. The transfusion of a large volume of high titre CCP in recently hospitalized patients may be beneficial. Aims: To evaluate the ability CCP transfusion to improve early outcome in patients with moderate to severe COVID-19 pneumonia. Methods: The CORIPLASM study was a multicentric, open-label, Bayesian randomized, adaptive, phase 2/3 clinical trial, nested within the CORIMUNO-19 cohort, to test a superiority hypothesis. Patients 18 years or older hospitalized with COVID-19 in 14 French centers, requiring at least 3 L/min of oxygen but without mechanic ventilation assistance and a WHO Clinical progression scale [CPS, 1 to 10] of 4 or 5 were enrolled. Patients were randomly assigned (1:1) via a web-based system, according to a randomization list stratified on center, to receive usual care plus 4 units of CCP (2 units/day over 2 days) (CCP group) or usual care alone (usual care group) on day 1 and 2 post-enrollment. Primary outcomes were the proportion of patients withWHO CPS greater than 5 on the 10-point scale on day 4 and survival without ventilation or additional immunomodulatory treatment by day 14. Results: One hundred and twenty patients were recruited from April 16th 2020 and April 21th 2021 and randomly assigned to the CCP group (n = 60) and to the usual care group (n = 60) and followed up for 28 days. Immunosuppressed patients comprised 43% (26/60) and 50% (30/60) of patients in the CCP and usual care groups, respectively. Median time from symptoms onset to randomization (days) was 7.0 [interquartile range (IQR): 5.0-9.0] in the CCP group and 7.0 [IQR: 4.0- 8.5] in the usual care group. Thirteen (22%) patients in the CCP group had a WHO CPS greater than 5 at day 4 versus 8 (13%) in the usual care group (adjusted odds ratio (OR): 1.88 [95% CI: 0.71 to 5.24]. By day 14, 19 (31.6%) patients in the CCP and 20 (33.3%) patients in the usual care group had needed ventilation, additional immunomodulatory treatment or had died (adjusted HR: 1.04 [95% CI: 0.55 to 1.97]). The cumulative incidence of death was 3 (5%) in the CCP group and 8 (13%) in the usual care group at day 14 (adjusted HR: 0.40 [95% CI: 0.10 to 1.53]), and 7 (12%) in the CCP group and 12 (20%) in the usual care group at day 28 (adjusted HR: 0.51 [95% CI: 0.20 to 1.32]). Frequency of severe adverse events did not differ significantly between both treatment arms. Subgroup analysis revealed that mortality at day 28 was mostly observed in the immunosuppressed patients (15/56 vs. 4/64) and that CCP was associated with less mortality in these patients (4/26 in the CCP group vs. 11/30 in the usual care group)(HR: 0.36 [95% CI: 0.14-0.97]). Summary/Conclusions: CCP treatment did not improve early outcome in patients with moderate-to-severe COVID-19 pneumonia. CCP-associated early respiratory worsening as well as CCP-associated reduced D14 and D28 mortality were observed, while not reaching statistical significance. CCP treatment was associated with reduced D28 mortality in immunosuppressed patients.
ABSTRACT
OBJECTIVES: COVID-19 vaccines have become the new hope for stemming the pandemic. We aimed to assess pre-launch vaccine acceptance among hospital workers in the Auvergne-Rhône-Alpes Administrative Region of France. METHODS: We performed a cross sectional study involving all hospital workers in 11 Auvergne-Rhône-Alpes hospitals in December 2020. Univariate and multivariate analyses were performed to identify factors associated with vaccine hesitancy. RESULTS: We analyzed completed questionnaires from 1,964 respondents (78% women, mean age 42 years, 21.5% physicians, 41% private care centers). A total of 1,048 (53%) hospital workers were in favor of COVID-19 vaccination. Vaccine hesitancy was associated with: female gender; young age; paramedical, technical, and administrative professions (i.e., all non-medical professions); no prior flu vaccination; and employment in the private medical care sector (p<0.05). Distrust of health authorities and pharmaceutical lobbying were the main obstacles to vaccination. Inversely, creating herd immunity and protecting patients and household members were the most frequently cited reasons in favor of vaccination. More than two-thirds of participants feared that the clinical and biological research was too rapid and worried about serious adverse effects. Most participants were interested in written information on the available vaccines, but the most vaccine-hesitant categories preferred oral information. Only 35% supported mandatory vaccination. CONCLUSIONS: Targeted written and oral information campaigns will be necessary to improve vaccination coverage among hospital workers who show a surprisingly high hesitancy rate. Imposing mandatory vaccination could be counterproductive.
Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Cross-Sectional Studies , Female , Hospitals , Humans , Male , SARS-CoV-2ABSTRACT
Introduction La vaccination contre la COVID-19 est devenue le nouvel espoir pour enrayer la pandémie. Le but de cette étude était d’évaluer les freins et déterminants de cette vaccination parmi le personnel hospitalier, juste avant que ne débute la campagne officielle de vaccination. Matériels et méthodes Une étude transversale multicentrique a été menée auprès de l’ensemble des personnels hospitaliers de 11 hôpitaux et cliniques d’une région française en décembre 2020, afin d’évaluer les freins et les déterminants à la vaccination contre la COVID-19. Des analyses uni- et multivariées ont été effectuées pour identifier les facteurs associés à l’hésitation à la vaccination. Résultats Au total, 1964 réponses ont été analysées : 78 % de femme, âge moyen 42 ans, 21,5 % de profession médicale, 41 % travaillaient en établissement privé. Au total, 1048 (53 %) travailleurs hospitaliers étaient en faveur de la vaccination contre la COVID-19. Le genre féminin, le jeune âge, les professions paramédicales, techniques et administratives (c.-à-d. non médicales), ainsi que le secteur privé étaient associées de façon indépendante à une plus grande défiance envers le vaccin (p<0,05). La méfiance envers les autorités de santé et les lobbies pharmaceutiques étaient les principaux freins à la vaccination. À l’inverse, créer une immunité de groupe, protéger ses proches et ses patients étaient les principales motivations à la vaccination. Plus de 70 % des participants trouvaient que la période de recherche avait été trop courte. La plupart des participants étaient intéressés par une information écrite sur les vaccins disponibles, mais les catégories socioprofessionnelles les plus réticentes préféraient une information orale. Seuls 35 % étaient favorables à une obligation vaccinale. Conclusion Il existe une surprenante importante défiance vis-à-vis de la vaccination COVID-19 chez les travailleurs en établissements de santé. Sur la base des informations recueillies sur les freins à la vaccination, des campagnes d’information écrites, orales et surtout ciblées (selon la profession, l’âge, le type d’établissement…) seront nécessaires pour améliorer la couverture vaccinale des personnels hospitaliers. Rendre obligatoire la vaccination pourrait être contre-productif.