COVID-19 Clinical Trials and Expanded Access

Historically and traditionally, the recommendations related to physical exercise duringpregnancy have been based more on moral or cultural issues than on scientific evidence.During some phases of history, pregnancy has meant a period of seclusion for women (notonly physical). One of the adverse consequences has been the common recommendation ofrest as a general rule for pregnant women.Scientific evidence from recent years has achieved a better understanding of the processof pregnancy and childbirth as well as maternal and fetal responses to exercise.Currently, both from a scientific and clinical/obstetric point of view, there is no doubtabout the benefits of an active pregnancy for entire body of pregnant woman, and even herchild. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation,even more with important associated complications during pregnancy and postpartum period.Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in thissense the necessary measures taken by the different administrations, especially in termsof confinement causes (from now on) a large number of complications affecting differentpopulations. In summary a complex situation without established prevention strategiesexists.The pregnant population is, due to the nature of the gestation and delivery process, oneof the population groups with the highest risk of adverse outcomes and associatedcomplications and whose consequences include the mother, fetus, newborn and evenchildren. According to an important body of scientific literature and based on anepigenetic effect, the intrauterine environment can be a determining factor for thefuture human being to evolve regardless of complications and pathologies (cardiovascular,metabolic, psychic, emotional). This is demonstrated by numerous recent scientificevidences that confirm the unfortunate association between an adverse intrauterineenvironment (due to various factors) and observable postnatal pathologies in infants.In addition, current publications report the large number and variety of alterations thatthe COVID-19 situation causes in pregnant women and that includes the entire femaleorganism. This complex situation does not only affect aspects of a physical orphysiological nature, but also psychic and emotional factors. In summary, a new state ofconfinement or similar situations in the near future (impossibility of groupings,distance between people), avoid during the daily life of pregnant women one of theimportant and recent recommendations made by the international scientific community: apregnancy physically active.This is especially relevant, due to the dangerous association between complications of apsychological or emotional nature during pregnancy with pre, peri and postnatal disorders(low birth weights, perinatal complications, altered and prolonged deliveries, etc.),which affect not only to the mother and can determine the health of the future humanbeing. According to the scientific literature and based on an epigenetic effect, theintrauterine environment can be a determining aspect in the health of the future humanbeing and the prevention of complications and pathologies (cardiovascular, metabolic,psychic, emotional). This is demonstrated by numerous and recent scientific evidencesthat confirm the unfortunate association between an adverse intrauterine environment (dueto various factors) and different pathologies during and after pregnancy.It is evident the change that COVID-19 and its effects will generate in the lifestyle ofthe pregnant population and the increased probability of suffering associated pathologiesin the next 24-36 months. No preventive actions have yet been planned in Spain and itspublic hospitals against the impact of COVID-19 on the quality of life of pregnant women.It is urgent to design and perform an adequate strategy of intervention for its possibleprevention. From the scientific point of view, the recommendations are clear andconcrete, an aerobic exercise program, designed and supervised by professionals from theSciences of Physical Activity and Sports, is the best option for pregnant women.In this sense, in the last 30 years, physical exercise has proven to have many benefitsfor pregnant women, without causing risks or adverse effects on maternal-fetalwell-being. This is confirmed by an important body of scientific literature ongestational physical exercise and its effects on pregnancy outcomes.

Since December 2019, China and then the rest of the world have been affected by the rapidspread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratorysyndrome coronavirus), the clinical expression of which is called Covid-19 (CoronavirusDisease 2019).It is estimated that around 20% of symptomatic patients will be severe enough to warranthospitalization, of which around 5% will be in intensive care.Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological,cardiovascular due to the infection or its care. There is also a psychological and socialimpact of the infection or of the care that should be measured.In this context, investigator will assess the physical and psychological complaints ofpatients who have presented a severe form of SARS-CoV-2 infection.The final objective being to identify the needs to offer follow-up adapted to thisemerging pathology.

The aim of the proposed project is to provide a comprehensive assessment of the mentalhealth impact of the ongoing COVID-19 outbreak in Spain. A prospective cohort study ofthree groups will be conducted: (1) COVID-19 cases or close contacts recently isolated orquarantined; (2) healthcare workers; (3) adult general population.Recruitment through epidemiologic surveillance services, hospitals, primary care centersin 6 Spanish Autonomous Communities (groups 1 & 2) and a random sample of individualsusing telephone numbers as the sampling frames(group 3). Web-based surveys or telephoneinterviews at baseline and 6-month follow-up assess: current living and employmentstatus; COVID-19 infection status; mental health (post-traumatic stress, panic,depression, anxiety, alcohol and substance use, suicidality; services use); psychologicalfunctioning; general health status and quality of life. Specific modules focus onisolation or quarantine (group 1) and care for COVID-19 patients (group 2). Shortbi-weekly brief follow-up surveys among groups 1 & 2 will provide additional assessmentof main outcomes in the two months following baseline assessment.

The main purpose of this study is to identify possible predictor factor of mortality inpatients affected by COVID-19 with respiratory failure needing oxygen therapy orventilatory support. In addiction the study aims to identify factors related to:predisposition to SARS-CoV2 viral infection, different symptoms, response to therapy,predisposition to complications related to the disease. To this end, the haemodynamicparameters and all imaging reports will be evaluated and clinical and laboratory tests aswell as cellular and molecular analyzes will be performed in the analyzed patients. Inaddition, investigations will be carried out on the profile of the alveolar or nasalmicrobiota and, if possible, of the metabolic products, and estimates on antibody titers.

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negativelyimpacted global health and requires more research to develop better tests and to improvedisease treatment.The purpose of this research is to aid in the testing effort by collecting samples frompeople who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samplesyou provide will be used investigationally by INanoBio to develop a test to determinewhen antibodies against various SARS-CoV-2 proteins are detectable.Up to approximately 80 subjects of all ages with either a suspected or lab-confirmeddiagnosis of COVID-19 will take part in this research.

NORPLASMA COVID-19 includes both the production of convalescent plasma from approvedblood donors who have recovered from covid-19 (coronavirus disease 2019), and clinicalstudies to evaluate efficacy and safety of the treatment, as recommended by Europeanhealth authorities. Patients who receive convalescent plasma in a clinical setting willbe invited to participate in the monitoring study NORPLASMA MONITOR, where clinical dataabout safety and effect on clinical parameters including virus load and recovery timewill be collected and compared to european patients in a common database for the Europeancountries. The treated patients can be compared to a historical control group.

The purpose of this study is to characterize the incidence and clinical features of thematernal COVID 19 infection, as well as the associated morbidity of the mother and thechild, in the French context

PHENOTYPE is an investigator-led, observational cohort study which aims to explore thelong-term outcomes of patients with COVID-19 infection and to identify potential riskfactors and biomarkers that can prognosticate disease severity and trajectory.

With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need tounderstand the impact of infection on immunodeficient individuals. Whilst co-morbidities(such as diabetes, cancer, arterial hypertension, heart disease...) have been documentedin people infected with SARS-CoV-2, there is currently no information on the consequencesand outcomes for individuals with primary immunodeficiencies (PID).Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui(CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of thenumber of affected PID patients and the impact of SARS-CoV-2 and directly focusing onobtaining this top level of information), we are launching the 2nd phase: "COPID19".COPID19 survey is a secured online GDPR compliant platform based in Paris (ImagineInstitute). It has been approved by the Paris-Necker-Enfants malades IRB and EthicsCommittee. However, this retrospective survey is designed for global distribution. Datacan be entered by a health care professional (mostly clinicians) through a personal loginand password.Each documenting person will have access to his/her own patients' data. COPID19 require agreater level of information than the 1st phase. The eCRF will be open to evolutionsdepending on progresses in our knowledge of this pandemic.

Primary Objective:To determine the efficacy of SAR442168 compared to placebo in delaying disabilityprogression in primary progressive multiple sclerosis (PPMS)Secondary Objectives:To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magneticresonance imaging (MRI) lesions, cognitive performance, physical function, and quality oflife To evaluate safety and tolerability of SAR442168 To evaluate populationpharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety Toevaluate pharmacodynamics of SAR442168