COVID-19 Clinical Trials and Expanded Access

By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients withpneumonia in Wuhan, China. In the following weeks and months the virus spread globally,having a tremendous impact on global health and economy. To date, no vaccine or therapyis available. Severe courses of the infection not only affect the lungs, but also otherorgans like the heart, kidney, or liver. The lack of preexisting immunity might at leastpartially explain the affection of extra pulmonary organs not yet seen in infections dueto other respiratory viruses. In this observational investigation the study group willfollow up on patients that have been hospitalized due to a SARS-CoV-2 infection, andmonitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system.Our that in some patients, organ damage will persist and require long-term medical care.

The aims of the BIBS StudyThe Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby'sbrain develops from before birth, up until 3-4 years of age. Working with children from avariety of backgrounds and communities, the investigators use a combination ofstate-of-the-art diagnostic tools such as MRI scans alongside traditional behaviouralassessments to capture the earliest information on infant brain development.The focus of the BIBS studyMRI scanning is a safe way of producing detailed images using strong magnetic fields andradio waves. It does not use X-ray. Along with learning more about brain development ingeneral, the investigators also try to identify features that may in future help predictwhether a child will or will not develop traits of conditions such as Autism SpectrumDisorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this mayhelp target useful interventions early on, helping children who are most in need.Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have beengiven ethical approval to include testing for this infection in the mothers and childrenparticipating in the study. This may provide an opportunity to better understand howmother and baby respond to infections. The investigators particularly welcome mothers whohave had a positive COVID-19 test during their pregnancy to join the study.

This is a prospective cohort observational registry study that will include data on allpatients who are treated at MHS facilities for COVID-19.

COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus,SARS CoV2 and is a serious condition with high mortality in hospitalised patients, forwhich there is no currently approved treatment other than supportive care. Urgentinvestigation of potential treatments for this condition is required.This protocol describes an overarching and adaptive trial designed to provide safety,pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biologicalsurrogates of efficacy which may support further development and deployment of candidatetherapies in larger scale trials of COVID-19 positive patients receiving normal standardof care.Given the spectrum of clinical disease, community based infected patients or hospitalisedpatients can be included. Products requiring parenteral administration will only beinvestigated in hospitalised patients. Patients will be divided into cohorts, a)community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computedtomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiringassisted ventilation. Participants may be recruited from all three of these cohorts,depending on the experimental therapy, its route of administration and mechanism ofaction. The relevant cohort(s) for any given therapy will be detailed in thetherapy-specific appendix.Candidate therapies can be added to the protocol and previous candidates removed fromfurther investigation as evidence emerges. The trial will be monitored by an independentData Monitoring Committee (DMC) to ensure patient safety.Each candidate cohort will include a small cohort of patients randomised to candidatetherapy or existing standard of care management dependent on disease stage at entry.Cohort numbers will be defined in the protocol appendices.This is a Phase IIa experimental medicine trial and as such formal sample sizecalculations are not appropriate.

The primary purpose of this study is to gain an understanding of how experiences duringthe COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domainsof health-related quality of life and other areas such as COVID-19 specific psychologicaldistress, and disruptions to health care, finances and social interactions. We will alsoevaluate the extent to which resiliency factors such as social support, perceivedbenefits under times of stress, and ability to manage stress may buffer associationsbetween COVID-19 experiences and HRQoL. To meet these objectives, we have developed a10-minute questionnaire that taps into these areas and is based on prior work addressingconcerns of other pandemics or national crises. Participants will have previouslyconsented to protocol PA15-0336 and have provided prior lifestyle data. This will allowus to connect the COVID-19 survey data with prior existing data.

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.

The goal of this project is to rapidly screen promising agents, in the setting of anadaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase2 platform design, agents will be identified with a signal suggesting a big impact onreducing mortality and the need for, as well as duration, of mechanical ventilation.