COVID-19 Clinical Trials and Expanded Access

At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will dieof complications. In patients with COVID-19, invasive treatment such as mechanicalventilation (e.g. breathing with a machine) is associated with a 50% increased risk ofdeath. Invasive treatments use a lot of healthcare resources in intensive care units andmay lead to further deaths if patients do not have access to care.The investigators aim to improve outcomes for COVID-19 patients by implementinghyperbaric oxygen therapy (HBOT). HBOT allows patients to breathe 100% oxygen in aspecial chamber at a pressure higher than sea level. It is approved by Health Canada for14 conditions. HBOT is safe when administered by experienced teams.There are two main causes of death in severe COVID-19 respiratory infections: (i) adecreased diffusion of oxygen from the lungs to the blood and (ii) an increasedinflammatory response (also called a "cytokine storm"). HBOT leads to increased oxygenlevel in blood, has strong anti-inflammatory effects, and may destroy the virusresponsible for COVID-19 disease. The initial experience with HBOT and COVID-19 fromChina, France and the United States is promising in that it prevents further worsening ofthe condition and need for intensive care.The investigators propose to test the effectiveness of HBOT for COVID-19 patients who areadmitted to hospital to receive extra oxygen. Using the most rigorous and innovativeresearch methods, this Canadian-led international study will operate at 5 centers across3 countries (Canada: Ottawa, Toronto, Edmonton; Switzerland: Geneva; UK: Rugby/London).The investigators anticipate that when treated by HBOT, COVID-19 patients needing extraoxygen to breathe will see significant health improvements as well as a decrease incomplications, inflammation in the blood, need for invasive care, death, and cost ofcare.

This study investigates the well-being and health-related quality of life in cancerpatients and survivors during the COVID-19 pandemic. Using questionnaires may helpresearchers gain an understanding of how experiences during the COVID-19 pandemic (e.g.,exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss offamily or friends, loss of income), may impact multiple domains of health-related qualityof life (physical, emotional and social well-being), and other areas such asCOVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms),and disruptions to health care, finances, and social interactions.

Acute Respiratory Distress Syndrome (ARDS) reflects the hallmark of the critical courseof coronavirus (COVID19). The investigators have recently shown that Exhaled BreathParticles (EBP) measured as particle flow rate (PFR) from the airways could be used as anoninvasive real-time early detection method for primary graft dysfunction (which bears apathophysiological resemblance to ARDS) in lung transplant patients. The investigatorshave also previously demonstrated the utility of PFR in early detection and monitoring ofARDS in a large animal model. PFR has been shown to be elevated prior to the cytokinestorm which classically occurs in ARDS. Early detection of ALI and ARDS is intimatelylinked to a patient's chance of survival as early treatment consisting of the preparationfor intensive care, prone positioning and protective mechanical ventilation can beimplemented early in the process. In the present study the investigators aim to usereal-time PFR as an early detector for COVID19-induced ARDS. The investigators will alsocollect EBPs onto a membrane for subsequent molecular analysis. Previous studies haveshown that most of those proteins found in bronchoalveolar lavage (BAL) can also bedetected in EBPs deposited on membranes. The investigators therefore also aim to be ableto diagnose COVID19 by analyzing EBPs using Polymerase Chain Reaction (PCR) with the samespecificity as PCR from BAL, with the added benefit of being able to identify proteinbiomarkers for early detection of ARDS.

This study investigates the impact of the COVID-19 pandemic on the psychosocial health ofemployees of MD Anderson Cancer Center. Epidemics have been shown to promotepsychological stress among medical staff in high risk areas, which may lead to mentalhealth problems. Assessing how the pandemic is affecting employees may allow for morecomprehensive actions to be taken to protect the mental health of employees.

COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highlycontagious viral disease, the condition of which main clinical symptoms are characterizedby fever and respiratory symptoms. Evidence indicates to worse outcomes in patients withpre-existing diseases, such as diabetes, arterial hypertension, heart disease,pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidneytransplants make prolonged use of immunosuppressive drugs to inhibit the acquired immuneresponse, notably the activity of lymphocytes. Due to this potential to modulate theimmune and inflammatory response, it is speculated that the clinical and laboratorycondition of COVID-19 in these patients is atypical. Preliminary evidence suggests worseoutcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However,information on kidney transplant recipients is insufficient. So far, only reports of thecase are available in the literature with different clinical presentations and outcomes.The aim of this study is, therefore, to characterize the demographics, clinical andlaboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in anational multicenter cohort.

This research aims to investigate the incidence, clinical condition, mode of transmissionand laboratory data of women and their babies, who were exposed to COVID-19 infectionduring pregnancy. This project will consist of 4 subprojects, being that Subprojects 1and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aimsto assess periodontal condition and quality of life before and after delivery of womenwith excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2-Identify the proteins differentially expressed in saliva associated with COVID-19infection during the 3rd trimester of pregnancy in obese and eutrophic patients.Subproject 3- Assess the prevalence of congenital syndrome in babies associated with thepresumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in whichnewborns are submitted to clinical examination, being a group with congenitalmalformations and their respective controls and an interview with the mother was carriedout.

The main differences observed between SARSCoV-2 pneumonia and other epidemic viralpneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, theclinical severity of the disease, particularly in young patients without co-morbidities,and the observation of radiological images related to significant parenchymal aggressionin a large number of patients.The lesions in the acute phase correspond essentially to bilateral ground glass opacitymore or less associated with condensations which would be markers of more severeinfections.The major scope of the lesions in the acute phase raises the question of whether or notthe scanning anomalies are completely resolved over time, and the possible impact on lungfunction. This risk of sequelae is very important to study given the large number ofpatients affected by SARSCoV-2, especially since these are often young patients whoappear to be "healthy".In the current context of the CoV-2 SARS pandemic, the improved quality and availabilityof diagnostic scanners provides a wealth of information on the semiology and progressionof lung disease with minimal exposure to ionizing radiation. A majority of hospitalizedpatients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, theFrench Society of Radiology has recommended the performance of a CT scan withoutinjection in thin sections in case of suspicion or for confirmation of the diagnosis inpatients presenting initial or secondary clinical signs of severity and justifyinghospital management due to the initial lack of reagents for performing biological tests(RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.The present study aims to study the kinetics of lung involvement in SARS CoV 2, to studythe predictive character of the chest CT scan performed at the patient's discharge on theexistence of radiological sequelae at 3 months but also at 1 year in order not tomisunderstand the constitution of late fibrosis after partial resolution of the CTimages. The investigatos will study the correlation between possible radiologicalabnormalities and the clinical presentation (patient symptoms and lung function). Therigorous follow-up of these patients will allow us to set up, if necessary, earlytreatment of the detected abnormalities (inhaled corticoids in case of bronchial orbronchiolar damage, study of the place of an anti-fibrosis treatment in case offibrosis,...).

There is a pandemic in the world by COVID-19. Currently, the pharmacological curative orprophylactic treatments for this infection are not known. Recent studies have suggestedthat Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. Themain objective of this study is to assess in patients with autoimmune disease treatedwith long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had anindependent protective effect on the risk or the severity of infection with COVID-19.

Postpartum depression (PPD) represent around 15% of birth in developed countries. Thecontext of the COVID-19 epidemy represents a possible source of additional emotionaldistress. The objective of this study is to determine the screening prevalence and riskfactors of postpartum depression, among women who deliver in fourth hospital in the Northof France in the context of the COVID epidemy.

Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminalcomplement products and is proposed for the treatment of COVID-19 inducedmicrovasculature injury and endothelial damage leading to thrombotic microangiopathy(TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants witha confirmed diagnosis of COVID-19 who clinically or diagnostically present withdeteriorating renal function. Ravulizumab causes immediate and sustained inhibition ofthe terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 inducedkidney injury due to TMA, shorten hospital stay, and improve the overall survival.