COVID-19 Clinical Trials and Expanded Access

Acute lung injury represents the most severe form of the viral infection sustained bycoronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged inDecember 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-likesyndrome with fever and cough; patients with clinical symptoms can perform a swab test,including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even ifdiagnosis and treatment are well described, to date, this viral pandemic infectioninduces an increased mortality in the world. The aim of the present project is toevaluate specific biomarkers that could be used for patient stratification and for tailortherapy in COVID-19 infected patients.

The main objective of this multicenter cohort study is to determine the degree of COVID19infection immunization of a population of psychiatric patients.The secondary objective of this cohort follow-up is to: 1. Clinically characterize COVID patients who are positive for serological testing 2. Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis 3. Immunologically characterize COVID patients who are positive for serological testing 4. Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

Oslo University Hospital has initiated an observational study on hospitalised patientswith confirmed COVID-19, the infection caused by Severe Acute Respiratory SyndromeCoronavirus type 2 (SARS-CoV-2).

The COVID-19 disease has been subject to numerous publications since its emergence.Almost 20% of people suffering from COVID-19 develop severe to critical symptoms andrequire hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is themain reason for admission in ICU of these patients. Therapeutic strategies implementedfor the management of critically-ill patients may often lead to short-term muscular andfunctional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead tolong-term disabilities expressing trough dependence and quality of life impairment ofsurvivors.The purpose of this study is to assess the quality of life, dependence and survival atone year in patients who survived from COVID-19 in ICU and are admitted in post-ICUsetting for difficult weaning purpose.Ancillary studies aim to assess the course of muscle function (atrophy, structuralmodifications), lung function (loss of aeration) and safety of early mobilization.

Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all5 continents, and responsible for a pandemic. France is the third most affected countryin Europe after Italy and Spain. Groups of patients at a higher risk of developing asevere form of COVID-19 have been defined: this include patients with immunosuppressivedisease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liverinjury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damageassociated with COVID-19 infection for compensated or decompensated cirrhotic patients.The objectives of this project are to estimate the incidence of COVID-19 inhepatocellular carcinoma population, both hospital and ambulatory, and to study theimpact on the frequency of severe forms, the prognosis, but also liver function, and themanagement of hepatocellular carcinoma, in this context of pandemic

The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 inasymptomatic healthcare workers (HCWs) in an early phase of community spread as well as2) to monitor the future spread of the disease by assessing serological responses toSARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve theassessment of the immune response and its protective effect as well as the assessment ofinfectivity of affected HCWs and 4) to evaluate the value and significance of antibodyformation and serological antibody tests and 5) to be able to evaluate possible futurepreventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccinationeffects

Emergent experimental and anecdotal evidence has indicated that critically ill COVID-19patients demonstrate two patient sub-types (called phenotypes). In one group the diseaseprogresses slowly and patients have a low potential of developing mild respiratoryfailure, but in the other group, an exaggerated immune response(hyper-inflammation/cytokine storm) may be linked to the onset of precipitous respiratoryfailure, termed acute respiratory distress syndrome. This syndrome is responsible for alarge portion of COVID-19 associated mortality. Thus, determining links betweenhyper-inflammation and acute respiratory distress syndrome in COVID-19 patients is ofimmediate importance. Blood samples will undergo a number of analyses to help us tounderstand as much as possible about COVID-19. We will also study any differences inphysiologic and cytokine levels before and after patients are treated withimmunomodulatory therapies as part of clinical care in COVID-19 patients.

This study is being conducted to study the use and application of a point-of-care (POC)Covid-19 test developed by Spartan BioSciences and recently approved for clinical use byHealth Canada. Phase I of this study will determine the best route for the swabs (nasal,throat, or both), and to determine if this POC test results are comparable to thestandard core-lab test results.

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g.immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigentests, like Turklab Test-It COVID-19 Home Test, AllBio Science Inc. and ArtronLaboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracycompared to Centers for Disease Control (CDC)-recommended molecular genetic testing andclinical diagnosis. Second, it is our goal to determine if self-testing assisted byCOVIDscanDX mobile device camera acquisition software platform and telemedicineclinical/technical support (virtual point-of-care) improves the ease of use and immediateinterpretation of the tests, thus making self-testing comparable in accuracy and safetyto testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 afterdiagnosis with COVID-19 or following vaccination to measure the onset and time course ofdetectable antibodies from finger-stick blood drops and rapid antibody lateral flowtests. The overall purpose of the study is to dramatically increase the capacity ofCOVID-19 testing by establishing the safety, ease-of-use and validity of self-testingassisted by mobile device imaging and telemedicine remote support and provide evidence ofantibody time-course response to vaccination.

Covid-SER is a prospective multi-center study for the evaluation of diagnosticperformance of available serological tests