COVID-19 Clinical Trials and Expanded Access

This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19. The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions on the survival and course of disease of patients with severe COVID-19. Convalescent plasma will be collected from recovered COVID-19 patients. Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients in the control group will receive best supportive care. Clinical condition in all patients will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline, patients in the control group may be switched to treatment with convalescent plasma on days 15, 17 and 19. Fifty-three patients will be included in each group. Data of each patient will be collected until discharge but nor longer than day 60.

This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

The pregnancy related pro-thrombotic state, in addition to the COVID-19 associated hypercoagulability may have unknown consequences to the developing fetus. Hence, this proposal seeks to address this question that may have important implications for women that contract this virus during gestation.

The current COVID-19 pandemic has affected more than 3 million people worldwide across more than 200 countries. In the United Kingdom alone, at the end of April, there were almost 160,000 confirmed cases with more than 20,000 deaths. This has undoubtedly had significant physical and economical impact on the public. Healthcare workers are at high risk of developing life-threatening infectious diseases with increased exposure to patients' blood and bodily fluids. As such, health care workers arguably experience heightened anxiety and are predisposed to greater negative psycho-social impact from the current COVID-19 pandemic. The aim of this study is to evaluate the physical and psychological impact of COVID-19 on healthcare workers. This will be performed in two phases. In phase 1, investigators will collect information to evaluate the current psychiatric symptom profile (in particular, screening for anxiety or depression related symptoms), alcohol use, sleep-related complaints and overall well-being among healthcare workers who participate in this survey (with a focus on junior doctors). In addition the association of these mental health and behavioural parameters with the prevalence of stressful occasions, such as long-hours, unpredictability of work / redeployment, availability of personal protection equipment and concerns regarding family/relationship and self will be assessed. In phase 2, investigators will then reassess for the development or progression of psychiatric symptoms, use of alcohol and other substances, behavioural or interpersonal relationship changes as well as physical well-being at 6 weeks and 4- months. Physical well-being is assessed through the presence of suspected or confirmed COVID-19 infection and absence from work. Specifically, investigators will study the impact of variable provision of personal protection equipment (supply and training), extended working hours, and concern for well-being of family members, on work morale and anxiety levels. Another aim is also study the longer term mental health consequences of the current pandemic on health care workers.

The aim of this study is to investigate whether vaccination of elderly with VPM1002 could reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2 pandemic . VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the "new corona virus" SARS-CoV 2.

The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers cope with these stressors.

In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.

The study is a cross-sectional survey study targeting patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Study staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for colonoscopy and alternative colon cancer screening options. Eligible patients will be sent a survey packet in the mail that will include a cover letter, an information sheet describing the study, an incentive, and the survey. The cover letter will include information for participants to opt-out if they desire. Patients will be asked to complete the survey and return it back to study staff. Consent is implied with return of the survey. For the study, staff plan to invite 300 patients and expect to receive 195 completed surveys. Analyses will examine whether COVID-19 has changed patients' interest in colon cancer screening and the strength of patients' preferences for colonoscopy and other approaches to colon cancer screening. It will then examine factors associated with positive and negative views on rescheduling colonoscopies such as anxiety, worry, and risk perceptions.

COVID-19 lockdown presents particular challenges for people living with obesity. Indeed during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours, home office, take care of child, social distancing... All of these modifications may have led to stress and anxiety. It has been previously demonstrated that high perceived stress levels are correlated with high preference for sweet and fat foods . In this context caution would be exercised in obese patients especially those with binge eating disorders. Indeed binge eating disorder is characterized by compulsive overeating or consuming abnormal amounts of food while feeling unable to stop and a loss of control. And one key trigger of binge eating disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more sensitive to the impact of lockdown and thus urgently would require appropriated care management. The main objective is to compare the eating behaviour between obese patients with or without binge eating disorders. The second objective is to compare the weight evolution between the two groups before and after the lockdown. To reach these objectives, the scientific team of the CIO project proposes to contact by phone and e-mail obese patients (with or without binge eating disorders) who have been hospitalized for their obesity disease before the start of the lockdown in the Endocrinology department of the Lyon Hospital. The patients will be asked to fill in several questionnaires (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge eating disorders… during the lockdown. The results of these questionnaires will be compared to those collected during their hospitalisation before the lockdown. The hypothesis is that participants suffering from binge eating disorder will have more sever eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.

Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic.