COVID-19 Clinical Trials and Expanded Access

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

Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemicwith high morbidity and mortality. The main cause of death is respiratory failureincluding acute respiratory distress syndrome, however the exact mechanisms and otherunderlying pathology is currently not yet known. In the current setting of the COVID-19pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission.Yet, as so little is known, additional histopathological, microbiological and virologicstudy of tissue of deceased COVID-19 patients will provide important clinical andpathophysiological information. Minimal invasive autopsy combined with postmortem imagingseems therefore an optimal method combining safety on the one hand yet provingsignificant information on the other.This study aims to determine the cause of death and attributable conditions in deceasedCOVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guidedMIA to obtain tissue for further histological, microbiological and pathologicaldiagnostics. In addition, the pathophysiology of COVID-19 will be examined by furthertissue analysis.

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

Mental health disorders are common during pregnancy and the postnatal period, and canhave serious adverse effects on the well-being of woman and child. Every tenth woman hasdepressive symptoms and 5% suffer major depression during pregnancy. The consequences forglobal mental health due to the novel coronavirus disease, COVID-19, are likely to besignificant and may have long-term impact on the global burden of disease. Pregnant womenmay be particularly vulnerable due to partial immune suppression. Besides physicalvulnerability, the women could be at increased risk of mental health problems, such asanxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancingleading to less support from the family and friends, and in some cases, partners notbeing allowed to be present during prenatal visits, labor and delivery. Furthermore, manypregnant women may feel insecure and worried about the effect of COVID-19 on their unbornchild, if the women get infected during pregnancy. Today, young urban women are used toutilizing internet services frequently and efficiently. Therefore, providing mentalhealth support to pregnant women via web-based support may be effective in amelioratingtheir anxiety/depression and reduce the risk of serious mental health disorders leadingto improved maternal and perinatal outcomes.

The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit insubject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.

Background:People who get infected with COVID-19 have an unpredictable risk to worsen and die. Thismakes it hard to decide who can quarantine at home and who should be treated at ahospital. Researchers think the risk may be related to how a person s B and T cellsrespond to the virus. B and T cells are the major components of a person s immuneresponse. B and T cells responding to the virus with a favorable pattern may lead torecovery, and this favorable pattern may be helpful to establish. If people in a vaccinetrial get this same favorable pattern when responding to a vaccine, this may be a usefulearly signal that the vaccine will be successful.Objective:To examine how immune cells respond to COVID-19 infection.Eligibility:Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or hadCOVID-19 in the past.Also, healthy donors with no suspected COVID-19 infectionDesign:Participants will be screened with medical record review.Participants will be tested with a research assay to determine who was infected withCOVID-19 and who was not. This test will be used to understand research results, not toadvise patients.Participants with active infection must be isolated, usually in a hospital.Other participants may give blood samples at NIH or at their local doctor s office orlab.Participants may give blood samples up to three times a week for a total of ten times,and may also give blood samples after starting a vaccine trial.Participants will be contacted by phone or email every 2 months for up to 2 years.

A phase II clinical trial will be carried out with the objective of studying the impactof the administration of Tocilizumab on the evolution of the acute respiratory distresssyndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the highmortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will notbe included. Patients will be recruited by signing an informed consent and the baselinevariables of interest will be recorded. Tocilizumab will be administered in one or twodoses, depending on the case, and will be followed up for 30 days. The response totreatment, survival and evolution will be studied. Factors associated with improvement ofARDS and survival will be identified through multivariate analyzes. The results will becompared with those reported internationally.

This is a prospective observational registry of COVID-19 recovered patients who are nolonger symptomatic. This Registry is intended to serve as a pool of individuals that canparticipate in studies associated with serological testing, characterization of immunityand immune response, vaccine development, and convalescent plasma donors.

The investigators hypothesize that those with respiratory failure due to COVID-19 willhave different burdens of mental and physical disability than those with respiratoryfailure who do not have COVID-19. Detecting these potential differences will lay animportant foundation for treating long term sequelae of respiratory failure in these twocohorts.

A lot of people suffer from phobias. Phobias concerning certain diseases are not rare.This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able torise phobias in people and if those with preexisting phobias or fears were more likely todevelop a phobia concerning COVID. It will look at different subtypes - physicians,medical staff, general public (not medically affiliated) and patients with psychiatricdisorders.