COVID-19 Clinical Trials and Expanded Access

the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctivaof covid-19 patients and the presence or absence of conjunctivitis in these patients

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.

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.

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, includingFibrotic Lung Disease due to inflammatory and reactive protein secretions damagingpulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas ofNew York-New Jersey, Washington, and California.Immediate attention is turned to testing, diagnosis, epidemiological containment,clinical trials for drug testing started, and work on a long-term vaccine started.The recovering patients are presenting with mild to severe lung impairment as a result ofthe viral attack on the alveolar and lung tissues. Clinically significant impairment ofpulmonary function appears to be a permanent finding as a direct result of theinterstitial lung damage and inflammatory changes that accompanied.This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascularfraction (cSVF) deployed intravenously to examine the anti-inflammatory and structuralpotential to improve the residual, permanent damaged alveolar tissues of the lungs.

This study is an adaptive, randomized, open-label, controlled clinical trial, incollaboration with countries around the world through the World Health Organization.

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

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.

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.