COVID-19 Clinical Trials and Expanded Access

Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus. The objectives are : - To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers. - To show that active smokers are less infected with COVID-19 than non-smokers. - To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.

Background: Traditionally, medical students learn surgical skills through the observation of a resident or a surgeon performing the technique. Due to inconsistent practice opportunities in the clinical setting, a disparity of skill levels among students has been observed. In addition, the poor availability of faculty professors is a limiting factor in teaching and adequately preparing medical students for clerkship years. With the ongoing COVID-19 pandemic, medical students do not have access to traditional suturing learning opportunities. Didactic courses are available on videoconferencing platforms, but they do not include technical training. Objective: Our overarching goal is to evaluate the efficacy of web-based peer-learning for advanced suturing techniques (i.e., running subcuticular sutures). The investigators will use GEN (Gamified Educational Network), a newly developed online learning tool. The investigators will assess students' ability to identify and to perform the right technique. The investigators will also assess students' satisfaction with regards to GEN. Methods: The investigators will conduct a prospective randomized controlled trial with blinding of expert examiners. First-year medical students in the Faculty of Medicine of Université de Montréal will be randomized to four groups: 1) control group, 2) self-learning, 3) peer-learning, and 4) peer-learning with expert feedback. Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN. For our primary outcome, students' ability to identify the right technique will be evaluated before and after the intervention on GEN. They will view eight videos and rate the surgical technique using the OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and the Subcuticular Suture Checklist as evaluation criteria. For our secondary outcomes, students will anonymously record themselves performing a running subcuticular suture and will be evaluated using the same scales. Then, a survey will be sent to analyze the overall performance of the platform. Results: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by our institutional review board (CERSES 20-068-D). No participants have been recruited yet. Conclusions: Peer-learning through GEN has the potential to overcome significant limitations related to the pandemic and the lack of availability of faculty professors. Further, a decrease of the anxiety related to traditional suturing classes can be expected. The investigators aim to create an innovative and sustainable method of teaching surgical skills to improve the efficiency and the quality of surgical training in medical faculties. With the current world events of COVID-19, the necessity for such tools are imperative.

The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

The main objective of the study will be to evaluate the effectiveness of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be depression severity and secondary outcomes will include health-related quality of life.

This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation. The authors therefore designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to: 1. assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective), 2. investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective), 3. report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).

This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy elderly aged 60 years and above.

Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic has spread around the world. The people most exposed to this virus remain the healthcare personnel who are on the front line in the fight against this pandemic. Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1. At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection. The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.