COVID-19 Clinical Trials and Expanded Access

Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract.Protection of health care workers during surgery has been increased and some guidelinesadvocate for abandoning laparoscopy in COVID19 patients for fear of contamination,evenghtough this does not benefit the patient. However, Sars-Cov2 contamination riskduring visceral surgery remains unknown. Inadequate protection is unnecessary costful andcan be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travelthrough droplet and air during visceral surgery. 2) Laparoscopy, because of thepneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrantmore droplet contamination, which would justified increased protection.

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.

COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1)Prospective longitudinal observational study involving patients with laboratory-confirmedCOVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19.Arm 1:We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens fromupper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratorytract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis asappropriate.Arm 2:The remainder of specimens that were submitted for laboratory investigation as part ofclinical management will be retrieved. Those specimens will only be used after allclinically indicated testing and confirmation procedures have been completed. Assistancefrom the Public Health Laboratory Service, Department of Health, will be invited toretrieve samples as well as participate in this study.Patients hospitalized for pneumonia in medical wards and ICU at the Prince of WalesHospital tested negative for COVID-19 will be recruited as controls.Understanding the clinical, virological, microbiological and immunological profiles ofthis infection is urgently needed to facilitate its management and control.

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.

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.

Our long-term goal is to protect the health care workforce (HCW) caring forSARS-CoV-2-infected patients, their families, communities, and the general population.Our specific objective is to rapidly establish a prospective cohort to characterize thefactors related to viral transmission and disease severity in a large healthcare system.We addressed this hypothesis by recruiting and longitudinally following 546 HCW and acomparison group of 283 non-HCW within a large academic health system, Rutgers Biomedicaland Health Sciences (RBHS). By intensively following participants over a several yearperiod (2020-2024) and collecting serial biospecimens (nasopharyngeal/throat swabs,blood, and saliva) and questionnaire data at multiple time points, we will uniquelycharacterize SARS-CoV-2 transmission and risk factors for COVID-19 among HCW and ourlarger academic community.

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.

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.

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.