COVID-19 Clinical Trials and Expanded Access

This is an observational study of patients with COVID-19 designed to specifically addressimportant clinical questions that remain incompletely answered for coronavirus disease2019.

The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public healthemergency of international concern by the World Health Organization.In the context of the health emergency, research on the pathogen (the SARS-CoV-2coronavirus), the disease and the therapeutic care is being organized. Research projectsrequire the use of biological samples. This study aims at setting up a collection ofbiological samples intended for application projects in any discipline.The main objective of the study is to collect, process and store biological samples frompatients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressourcescenter of the Bordeaux University Hospital.

The viral Covid-19 outbreak is now considered a pandemic according to the World HealthOrganisation (WHO). A free monitoring app 'COVID-19 Symptom Tracker' has been developedto record and monitor the symptoms of the COVID-19 coronavirus infection; tracking inreal time how the disease progresses. The app also records how measures aimed atcontrolling the pandemic including self-isolation and distancing are affecting the mentalhealth and well-being of participants. The data from the study will reveal importantinformation about the symptoms and progress of COVID-19 infection in different people,and why some go on to develop more severe or fatal disease while others have only mildsymptoms do not.

This is an double-blind, randomized, placebo controlled phase III study in hospitalizedsubjects with confirmed SARS-CoV-2.

Prospective cohort study of COVID-19 infection among children in Norway.

In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan,Hubei Province in the People's Republic of China. The disease spreads rapidly and thenumber of sick people is increasing. On January 3, 2020 a new virus of the coronavirusfamily is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhanand subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the WorldHealth Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is apandemic.As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with morethan 16,000 deaths attributed to this virus. (Ref WHOhttps://www.who.int/emergencies/diseases/novel-coronavirus-2019 ).In France, the number of cases rose from 105 cases at the end of February to 19615confirmed cases on March 24. (Source Public Health France). Most of the cases are adults.However, children are not completely spared and serious cases have been described. Thesesevere cases can be respiratory or extra-respiratory (e.g. myocarditis). We also knowthat pediatric and adult cases differ in terms of clinical, biological and imagingfindings, particularly chest CT scans. However, the description of paediatric pictures,especially severe forms and the involvement of children suffering from co-morbidities,remains poorly reported. Finally, the risk factors for serious cases in children remainlargely unknown.This observatory aim to describe the clinical phenotypes of hospitalized pediatricpatients with Covid19 in France, according to age groups. Moreover for a subgroup ofpatients, informations regarding the long covid will be reported.

An increased risk of both venous and arterial thromboembolism was noted in reports fromSARS-CoV-2-infected patients in China and has been confirmed in autopsy findings frompatients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), whichencompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, arethrombophilic disorders with a natural propensity to thrombosis that is fuelled by theintrinsic activation of inflammatory cytokines. It therefore follows that an underlyingdiagnosis of MPN may increase the risk of worse clinical outcomes and death duringperiods of active Covid-19 disease. This ambispective, observational study aims toelucidate the key factors which affect the clinical course of patients with MPN whodevelop Covid-19 disease.

Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)pandemic has spread around the world. The people most exposed to this virus remain thehealthcare personnel who are on the front line in the fight against this pandemic. Due tothe delayed nature of the pandemic in Reunion island and its insular geographicalsituation, the study of the voluntary medical personnel will allow the investigators toestablish a longitudinal follow-up of the anomalies of the lipidic balance in relation tothe exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profilesare profoundly modified with very significant reductions in plasma cholesterol levels,LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles arealtered during viral infections, for example, the severity of dengue is inverselycorrelated with total cholesterol and LDL-C but not with HDL-C levels, according to arecent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteinsrich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptorclass B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the denguevirus and increase its infectivity by promoting its entry into cells, also via SRB1. Atthe moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. Theinvestigator hypothesize that a drop in plasma HDL-C levels and a change in their sizeduring infection could justify future therapeutic approaches aimed at supplementing thesubjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosapneumonia in mice, investigators have shown that the injection of reconstituted HDLallowed to limit the pulmonary inflammation and the deleterious consequences of theinfection. The investigator propose to study not only the lipid profiles in subjects whoare infected with SARS-CoV-2 but also the polymorphisms of genes involved in theregulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP)depending on the developed forms, symptomatic or not.

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.

Randomized open label clinical trial carried out at study centers in Sweden, includingKarolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and VästmanlandsHospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligiblefor inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µgtwice daily or to standard of care. Primary outcome is duration of received supplementaloxygen therapy. Key secondary outcome is a composite outcome of death and receivedinvasive mechanical ventilation within 30 days.