COVID-19 Clinical Trials and Expanded Access

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has poseda challenge globally. Health care providers are highly exposed and are an important groupto test. On top of these concerns, health care workers are also stressed by the needs onresponders in the COVID-19 crisis. The investigators will look at different ways tomeasure how common COVID-19 is among health care workers, how common is the presence ofantibodies by serological tests (also known as serostatus). The investigators willdescribe health worker mental and emotional well-being and their coping strategies intheir institutional settings. Lastly, the investigators will describe how knowingserostatus can affect individuals' mental and emotional well-being and how to cope in themidst of the COVID-19 response. This will help to how to better test and help healthcareworkers in the COVID-19 pandemic and prepare for possible future outbreaks.

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

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptorblockers (ARB), since this virus shares hemagglutinin as a transmission mechanism andacts on the ACE2 enzyme during infection.Other authors described how none of the elderly patients receiving antihistamines andazythromycin in two nursing homes in Toledo -Spain- during the first wave died or neededhospital admission, even considering that 100% of residents had a positive serologicaltest after that wave. Other authors have described a positive evolution in patientsreceiving amantadine for their Parkinson's disease.The aim is to evaluate whether the admitted patients who are previously vaccinated orthose who were already receiving these treatments showed a better evolution.

The purpose of this data repository is to provide a secure and centralized storagelocation and resource for the collection of essential data and medical specimens, acrossCOVID-19 related protocols at Duke.

SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19.The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specificimmune responses. COV-CREM is a French prospective monocentric study that will evaluateviral-specific cell responses in positive patients for SARS-CoV-2 on the basis of(RT-PCR) assay performed in respiratory tract sample tested by our local Center forDisease Control.

This is a prospective study, involving contacting potential plasma donors and the use oftheir plasma to help fight off infections of those suffering from COVID19 in accordanceto collection guidelines for plasma and FDA IND requirement. This study will include upto 240 participants potentially receiving convalescent plasma and up to 1000 potentialdonors.There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3severity groups are eligible for enrollment, but mild severity will not be given plasmaunless there is progression. Moderate severity will given up to 1 unit of plasma andsevere/critical severity up to 2 units. There is no placebo group, however given theexcepted issues of shortages of plasma, intention to treat will be used for analysis.

The understanding of haemostasis and inflammation cross-talk has gained considerableknowledge during the past decade in the field of arterial and venous thrombosis. Complexand delicately balanced interaction between coagulation and inflammation involve allcellular and humoral components.Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xamay increase inflammation by promoting the production of proinflammatory cytokines,chemokines, growth factors and adhesion molecules that lead to a procoagulant stateamplifying the pathological process. Recent evidence supports inflammation as a commonpathogenic contributor to both arterial and venous thrombosis, giving rise to the conceptof inflammation induced thrombosis.Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk ofthromboembolism. The purpose of this project is to analyze hemostasis and coagulation ofevery hospitalized patient with infection of COVID-19.Blood sample for coagulation and hemostasis analysis will be collected on every patienthospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II,fibrin/fibrinogen degradation products, antithrombin will be assessed every week.Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM atday of admission and at fourth week after admission will be assessed. SARS-CoV2 viralload and serodiagnosis will be performed at the same time. At the same time venousultrasound to diagnose thrombosis will be performed.

The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depthcharacterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposesa transdisciplinary approach to identify host factors resulting in hyper-susceptibilityto SARS-CoV-2 infection, which is urgently needed for directed medical interventions.

Researchers are creating a real time COVID-19 registry of current ICU/hospital carepatterns to allow evaluations of safety and observational effectiveness of COVID-19practices and to determine the variations in practice across hospitals.

In the United Kingdom, there are currently 138,000 confirmed patients with coronavirus,causing 18,738 deaths. Whilst the disease may be mild in the majority of patients, asignificant proportion of patients require intensive care therapy and a ventilator due tolung injury. In addition to lung injury/failure (acute respiratory distress syndrome(ARDS)), around 50% of patients admitted to intensive care develop acute kidney injury(AKI) (requiring advanced support via haemofiltration) and multi-organ failure.It is unclear why patients suffering from COVID-19 develop such severe lung injury(requiring life support or ventilation) or indeed why patients develop other organdysfunction such as kidney injury. The investigators hypothesis that this may due to anover-reaction of the immune system particularly in the lungs. This then results in therelease of various mediators and biological messengers which can be pushed into the bloodbloodstream (exacerbated by positive pressure generated by the ventilator). Thesemediators then travel, via the blood, to other organs such as the kidney where they causeinflammation and injury of cells, resulting in organ failure.The investigators would like to apply their well-established laboratory methods tofurther the scientific community's knowledge of this severe and deadly viral conditionand we hope that this would lead to the development of medication that would treat thisdeadly virus.