COVID-19 Clinical Trials and Expanded Access

Predi-COVID is a prospective cohort study composed of people positively tested forCOVID-19 in Luxembourg, followed digitally for monitoring participants' health evolutionand symptoms at home. Participants will be actively followed for 14 days from the time ofconfirmation of diagnosis, whether they are at the hospital or at home in isolation orquarantine. Short evaluations will be also performed at week 3 and week 4 and thenmonthly for a period up to 12 months to assess potential long term consequences ofCOVID-19. A subsample of 200 participants will be contacted to integrate complementaryclinical data and collect samples.The study aims at identifying factors associated with the COVID-19 disease severity.COVID-19 patients with severity criteria will be compared to patients with mild diseasemanaged at home.A deep phenotyping related to the symptoms of the disease as well as biosampling allowingfor laboratory-based and computational analytics will be performed.

The purpose of the study is to design and execute a prospective, longitudinal,descriptive cohort study in a pragmatic clinical practice for adults with symptoms thatmay be related to COVID-19.

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalisedwith pneumonia.The treatments being investigated are:COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin,Colchicine, IV Immunoglobulin (children only), Convalescent plasma,Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab,Molnupiravir, Paxlovid or Anakinra (children only)Influenza: Baloxavir marboxil, Oseltamivir, Low-dose corticosteroids - DexamethasoneCommunity-acquired pneumonia: Low-dose corticosteroids - Dexamethasone

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratorysyndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimentalefficacy with a potential to be used for Coronavirus disease 2019.

The study researchers think that a medication called N-acetylcysteine can help fight theCOVID-19 virus by boosting a type of cell in your immune system that attacks infections.By helping your immune system fight the virus, the researchers think that the infectionwill get better, which could allow the patient to be moved out of the critical care unitor go off a ventilator, or prevent them from moving into a critical care unit or going ona ventilator.The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat theliver side effects resulting from an overdose of the anti-inflammatory medicationTylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in thelungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD).This study is the first to test N-acetylcysteine in people with severe COVID-19infections.

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.

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 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.