COVID-19 Clinical Trials and Expanded Access

The COVID-19 pandemic is causing many deaths around the world, putting a strain on healthservices. Patients with pre-existing chronic conditions are most affected by theSARS-COV2 infection. Infectious complications are a common cause of mortality and one ofthe main causes of morbidity in all these diseases. The main objective of this project isthe assessment of patients with thalassemia, drepanocytosis, other haemoglobinopathiesand rares inherited anemias suffering from SARS-COV-2 to: 1. Obtain clinical and epidemiological data that can provide information on a possible increased vulnerability of these patients to SARS-COV-2 infection; 2. Sharing therapeutic approaches considering the lack of information about the treatment.

This is a prospective, multi-center, observational study that will enroll patientsreceiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidneytransplantation who will be vaccinated against COVID-19.

The Hearts of Athletes study is being conducted to determine the heart involvement withCOVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)• Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, orOlympic Athlete will be eligible for the study.With COVID-19• COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollmentOr without COVID-19• Identified as a local Control participant (similar sport) to a participant withCOVID-19, who is willing to undergo a standard cardiovascular evaluationParticipants with and without COVID-19 will use their mobile devices to provide healthinformation, like symptoms, by answering survey questions daily for 30 days. Also,participants will allow their de-identified cardiac images to be sent to the Duke HeartCenter for blinded analysis.No physical risks are associated with this study. One possible risk, although minimal, isloss of confidentiality.

The overall purpose of this project is to better understand the epidemiology of COVID-19in patients with hematological malignancies (including hematopoietic stem cell transplantrecipients) in the different European Countries. The results obtained will allow us tobetter know the prevalence of this complication in the different categories of patientswith hematological malignancies (HMs). In order to attain the objectives previouslydescribed we will develop a multicentre, international, observational, retrospective andprospective study of consecutive cases of COVID-19 among HMs. There will be a clinicalfollow-up of the patients included in this study to observe the survival rate. Datacollected form this study will be evaluated with a descriptive analysis.

Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson mechanical ventilation.

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.

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.