COVID-19 Clinical Trials and Expanded Access

The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity andmortality in over 170 countries. Increasing age and burden of cardiovascularcomorbidities are associated with a worse prognosis among patients with COVID-19. Inaddition, serologic markers of more severe disease including coagulation abnormalitiesand thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19infection and are more common in patients who died in-hospital. As the COVID-19 pandemiccontinues to grow, there is a pressing need to identify safe, effective, and widelyavailable therapies that can be scaled and rapidly incorporated into clinical practice.Understanding the putative mechanism of increased mortality risk associated with abnormalcoagulation function and cardiac injury is critical to guide studies of promisingtherapeutic interventions. Published and anecdotal reports indicate that endothelialdysfunction and thrombosis are common in critically ill patients with COVID-19, includingreports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys.Patients with cardiovascular disease (CVD) and CVD risk factors are known to haveendothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mLwas associated with an 18 times higher risk of in-hospital death, underscoring theimportance of increased coagulation activity as a potential modifiable risk marker thatmay drive end-organ injury. Given the established link between endothelial dysfunctionand thrombosis in patients with cardiovascular disease, and the association betweencoagulopathy and adverse outcomes in patients with sepsis, the association betweenincreased coagulation activity, end-organ injury, and mortality risk may represent amodifiable risk factor among COVID-19 patients with critical illness. Therefore, wepropose to conduct a randomized, open-label trial of therapeutic anticoagulation inCOVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety.

This retrospective study aims to perform a medication risk stratification using drugclaims data and to simulate the impact of the addition of various repurposed drugs on theMedication Risk Score (MRS) in a health insurance population. Our clinical tool wouldenable us to identify potential multi-drug interactions and potentially reduce the riskof adverse drug events (ADE) developing in these patients infected with COVID-19.

Prospective study evaluating the outcomes of implementation of a protective protocol forCovid-19 for patients and staff in a large endoscopy unit.

The primary objective of the study is to evaluate cardiac and pulmonary hemodynamicchanges over time as predictor of disease progression and outcome in COVID-19 patientsadmitted to ICU.The primary endpoint is the occurrence of a major event predefined as either: death(all-cause mortality) or discharge from ICU (limit of 4 months).This is a uni-center prospective observational cohort study with an inclusion period of 2months. The end of the study is foreseen in 6 months.

The COVID-19 CHAMPS Study will obtain data on the physical and mental health andwell-being of workers potentially exposed to the SARS-CoV-2 virus in the course of theirduties. Included are a broad range of occupations including those working in thecommunity (police officers, firefighters, emergency personnel, screening staff) as wellas in permanent or temporary sites that care for patients (service staff, nurses,physicians and other health professionals). CHAMPS will obtain data on various exposurefactors and health and create a registry of participants for extended follow up andsub-studies.

Patient are being asked to provide respiratory and blood samples for a clinical researchstudy because the patients have a virus called the novel coronavirus, or SARS-CoV-2, thatcauses the disease known as Covid-19.Investigators do not know a lot about this virus, including all the ways it travels fromperson to person. Investigators also do not know if a person will get sick or not fromthe virus after being in close contact with someone who has the virus. Because of this,investigators are performing research on the virus found in respiratory secretions to getmore information on how investigators can best detect and treat this new virus in thefuture.Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children..Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

Experience from the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak taught thathealthcare workers (HCWs) often experience chronic stress effects for months or yearsafter such an event, and that supporting HCWs requires attention to the marathon ofoccupational stress, not just the sprint of dramatic stressors that occur whileinfections are dominating the news. This study will test if the well-being of hospitalworkers facing a novel coronavirus outbreak is improved by adding either of twointerventions: (1) Peer Resilience Champions (PRC): an interdisciplinary team ofprofessionals who actively monitor for early signs of heightened stress within clinicalteams, liaise between staff and senior management to improve organizationalresponsiveness, and provide direct support and teaching (under the supervision of expertsin resilience, infection control, and professional education). Investigators will testthe effectiveness of this PRC Intervention by rolling it out to different parts of thehospital in stages and comparing levels of burnout before and after the interventionreaches particular teams and units (a stepped wedge design). By the end of the study, PRCSupport will have been provided to all clinical and research staff and many learners (>6,000 people). Note that the provision of PRC support will be directed to the entireorganization. The research portion of the study is the evaluation of PRC support througha repeated survey completed by consenting staff. Investigators will test theeffectiveness of the PRC by measuring trends in burnout and other effects of stress overthe course of the study in a subgroup of hospital workers (as many as consent, target~1000 people) through an online questionnaire (called "How Are You?"). (2) The secondintervention is an enriched version of the "How Are You?" Survey, which providespersonalized feedback about coping, interpersonal interactions and moral distress.Participants will be randomized (1:1) to receive the shorter Express Survey (identifyingdata and outcome measures only), or the Enriched survey (all of the Express measures plusadditional measures with feedback based on responses). It is hypothesized that both thePRC intervention and the Enriched Survey intervention will help prevent or reduceinstances of burnout in HCWs.

The COVID-19 disease has been subject to numerous publications since its emergence.Almost 20% of people suffering from COVID-19 develop severe to critical symptoms andrequire hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is themain reason for admission in ICU of these patients. Therapeutic strategies implementedfor the management of critically-ill patients may often lead to short-term muscular andfunctional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead tolong-term disabilities expressing trough dependence and quality of life impairment ofsurvivors.The purpose of this study is to assess the quality of life, dependence and survival atone year in patients who survived from COVID-19 in ICU and are admitted in post-ICUsetting for difficult weaning purpose.Ancillary studies aim to assess the course of muscle function (atrophy, structuralmodifications), lung function (loss of aeration) and safety of early mobilization.

The COVID-19 outbreak has been rapidly transmitted in late January 2020 and arousedenormous attention globally. The public at large may also experience boredom,disappointment, and irritability under the isolation measures. Depression and anxiety arecommon mental health problems experienced by university students. This survey aims toinvestigate the psychological impact of COVID 19 on students.

Patients with COVID-19 diagnoses are treated under isolation in hospitals and withhigh-stress level. Currently, there is little information on the mental healthimplications of exposure amongst COVID-19 survivors and their family members. Researchexploring the psychological impact amongst survivors of exposure to COVID-19 isdesperately needed to understand the effects, mental health toll, and support required insurvivors of COVID-19. This study aims to assess the psychological impact of the COVID-19outbreak on COVID-19 survivors and their family members.