COVID-19 Clinical Trials and Expanded Access

To measure the frequency of persistent liver dysfunction (raised liver enzymes, serumalbumin, prothrombin time, etc) in recovered COVID -19 patients.To compare the hepatic manifestations in post COVID -19 patients with and without liverdisease

Safe and effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinesmay reduce the transmission of and achieve population immunity against the COVID-19pandemic, which accounted for more than 3.75million deaths worldwide. With World HealthOrganization's (WHO) effort on ensuring equitable access to COVID-19 vaccines,vaccination rate may increase in the near future.On the other hand, vaccination hesitancy has emerged as a major hindrance on the globalvaccination campaigns in certain areas due to safety concerns, social factors, and publichealth policies. For instance, a recent survey conducted in Hong Kong showed a lowvaccine acceptance rate of 37%. Long-term safety concerns and post-vaccination eventsrelayed by the social media maybe reasons for vaccination hesitancy. Among which,cerebrovascular accidents (CVA) after vaccination were one of the most frequentlyreported post-vaccination events. These reports ranged from ischemic strokes in elderlypatients with multiple cardiovascular co-morbidities, to hemorrhage strokes in otherwise"young-and-fit" adults. While many of these events were investigated by the COVID-19immunization expert committee, an important premise to address the apprehension of CVAafter vaccination is the provision of evidence-based information of the impact ofCOVID-19 vaccines on brain health.In this prospective, longitudinal, observational study, we aim to elucidate therelationship between COVID-19 vaccines and cerebrovascular health in healthy citizens ina population-based cohort.

An outbreak of the novel coronavirus nCoV-19 (SARS-CoV-2), responsible for thecoronavirus disease-19 (COVID-19), was first detected in Hubei province, Wuhan, China, onDecember 31, 2019. It has rapidly spread globally with approximately 157,343,044confirmed cases and 3,278,510 deaths till 7th May, 2021 [1]. World Health Organization(WHO) declared COVID- 19 pandemic on 11th March 2020.The world is facing the second wave of Coronavirus Disease 2019 (COVID-19) pandemic whichis the most troublesome challenge to public health. The second wave is running and nobodyknows where we are in the course of this disease. It becomes a significant challenge forthe public health, science, and medical sectors [2].According to the World Health Organization, about 80% of infections are mild orasymptomatic, 15% result in moderate to severe symptoms (requiring oxygen) and about 5%are critical infections, which require ventilation.We are learning something new every day. Our understanding of the pandemic is growing andchanging daily. The world is focusing on the short term - flattening the curve, treatingthe sick and discovering a vaccine. But there is more to this pandemic than the shortterm.We know a lot about the transmission and clinical feature of COVID-19, but relativelylittle about what happens after someone recovers. Much is still unknown about howCOVID-19 will affect people over time. There's still much to be learned from those whohave recovered from COVID-19.

People living with HIV could have different susceptibility and outcome to the SARS CoV-2infection. The risk of SARS CoV-2 infection in this population could be no related to HIVinfection, immunodepression or antiretroviral therapy, but to the differentsusceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infectioncould have different cytokine profile and cellular immune response after SARS-CoV-2infection, leading to a differential outcome,

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated withan increased risk preterm birth, cesarean section, and maternal critical care. This studywill examine the factors that impede testing for SARS-CoV-2 (the causative virus amongpregnant women), help determine optimal testing strategies by evaluating the necessity oftesting for asymptomatic disease in pregnancy, inform prenatal care plans by assessingthe full impact of infection, and contribute to a provider's ability to counsel women andcreate prenatal care plans if they are pregnant or considering pregnancy.

At present, the offer of tests for the serological diagnosis of CoVID-19 (detection ofIgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of avery large number of rapid diagnostic unit tests, a few dedicated high throughputautomated systems or reagents on existing open systems. The offer will continue to expandin the coming months.In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HASreport of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific councilconcerning the potential use of these serological tests at the end of the COVID-19epidemic, the Virology laboratory wishes to validate the sensitivity and specificity ofthe tests it intends to use.

Multicenter observational study of diagnostic test validation (Research Involving theHuman Person, type 3) In addition to the diagnosis by the reference method(nasopharyngeal swab), the patient will be asked to provide a saliva sample via asalivary spit. The clinical circumstances of the diagnosis, the age of the patient, theassociated terrain (diabetes, immunodepression, pregnancy) will be noted. Thenasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining sampleswill be frozen and stored at the CRB before being sent to the University Hospital of Caenfor analysis and concordance verification.The expected benefits are:Possibility of repeating tests in the same person more easily due to the absence of painand thus reduce the barriers to diagnosis and screening.Possibility of self-sampling, which could simply be sent to the laboratory, which wouldrelieve the diagnostic sites that mobilize staff and require a fairly heavy organization.Avoid long waiting lines that can be an obstacle and lead to a renunciation of thediagnosis.

Detection of the incidence and types of arrhythmia and conduction block in COVID - 19patients Detection and description of CMR patterns of myocardial injury in COVID-19patients with arrhythmias.

Since the beginning of the year, the entire world has been concerned with the novelSARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapidincrease in the number of cases in Germany as well. In case of an illness with the virus,the affected patients can suffer from a slight infection of the upper respiratory tractup to severe lung failure and death. Interestingly, up to now, children are usually lessseverely affected than adults. However, the actual infection rates are probably similarto those of adults, even if the actual prevalence in children is difficult to quantify sofar. The extent of the disease in children has also been less researched to date than inadults, and the same applies to pregnant women and their newborns. In addition, intensiveresearch into possible therapeutic strategies and new vaccines is necessary. Here,however, the number of clinical studies in children is also far behind. In order to beable to understand the infection process and to protect the population with theirchildren, comprehensive testing is necessary. However, this poses great challenges forlocal health authorities. Scientific investigations are also costly, but are alreadybeing carried out by many institutes. So far, for example in the SeBlueCo study, a verylow prevalence of antibodies (1.3% of people) has been show. In children, however, boththe routes of infection and the way the immune system deals with the virus are probablydifferent than in adults. In this study the investigators now want to examine residualblood samples from pediatric patients of the pediatric and adolescent clinic in the timecourse after the beginning of the pandemic in order to better understand and monitor thedevelopment of antibody prevalence.

In order to prevent reinfection, it is needed to detect the cellular-mediated immuneresponse to the Sars-CoV-2 infection. The first goal of this study will be to detect thecellular-mediated immune response in patients affected by COVID-19 (with or withoutvaccination) and healthy subjects who undergone vaccination program. The second goal ofthis study will be to identify the genetic and epigenetic biomarkers that influenceindividual immunological response and clinical evolution to the severe manifestations ofthe COVID-19.