COVID-19 Clinical Trials and Expanded Access

This research aims to investigate the incidence, clinical condition, mode of transmissionand laboratory data of women and their babies, who were exposed to COVID-19 infectionduring pregnancy. This project will consist of 4 subprojects, being that Subprojects 1and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aimsto assess periodontal condition and quality of life before and after delivery of womenwith excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2-Identify the proteins differentially expressed in saliva associated with COVID-19infection during the 3rd trimester of pregnancy in obese and eutrophic patients.Subproject 3- Assess the prevalence of congenital syndrome in babies associated with thepresumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in whichnewborns are submitted to clinical examination, being a group with congenitalmalformations and their respective controls and an interview with the mother was carriedout.

The main differences observed between SARSCoV-2 pneumonia and other epidemic viralpneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, theclinical severity of the disease, particularly in young patients without co-morbidities,and the observation of radiological images related to significant parenchymal aggressionin a large number of patients.The lesions in the acute phase correspond essentially to bilateral ground glass opacitymore or less associated with condensations which would be markers of more severeinfections.The major scope of the lesions in the acute phase raises the question of whether or notthe scanning anomalies are completely resolved over time, and the possible impact on lungfunction. This risk of sequelae is very important to study given the large number ofpatients affected by SARSCoV-2, especially since these are often young patients whoappear to be "healthy".In the current context of the CoV-2 SARS pandemic, the improved quality and availabilityof diagnostic scanners provides a wealth of information on the semiology and progressionof lung disease with minimal exposure to ionizing radiation. A majority of hospitalizedpatients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, theFrench Society of Radiology has recommended the performance of a CT scan withoutinjection in thin sections in case of suspicion or for confirmation of the diagnosis inpatients presenting initial or secondary clinical signs of severity and justifyinghospital management due to the initial lack of reagents for performing biological tests(RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.The present study aims to study the kinetics of lung involvement in SARS CoV 2, to studythe predictive character of the chest CT scan performed at the patient's discharge on theexistence of radiological sequelae at 3 months but also at 1 year in order not tomisunderstand the constitution of late fibrosis after partial resolution of the CTimages. The investigatos will study the correlation between possible radiologicalabnormalities and the clinical presentation (patient symptoms and lung function). Therigorous follow-up of these patients will allow us to set up, if necessary, earlytreatment of the detected abnormalities (inhaled corticoids in case of bronchial orbronchiolar damage, study of the place of an anti-fibrosis treatment in case offibrosis,...).

There is a pandemic in the world by COVID-19. Currently, the pharmacological curative orprophylactic treatments for this infection are not known. Recent studies have suggestedthat Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. Themain objective of this study is to assess in patients with autoimmune disease treatedwith long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had anindependent protective effect on the risk or the severity of infection with COVID-19.

Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminalcomplement products and is proposed for the treatment of COVID-19 inducedmicrovasculature injury and endothelial damage leading to thrombotic microangiopathy(TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants witha confirmed diagnosis of COVID-19 who clinically or diagnostically present withdeteriorating renal function. Ravulizumab causes immediate and sustained inhibition ofthe terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 inducedkidney injury due to TMA, shorten hospital stay, and improve the overall survival.

This study will define the kinetics of IgG responses to both N and S proteins in thesubjects who suffered from COVID 19 and then had recovered and those who were previouslyundiagnosed but were seropositive. These subjects will be followed for four months toevaluate the levels of antibodies in these people.

To evaluate the spectrum of comorbidities and complications and its impact on theclinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19).

The data obtained from Covid-19 infections seem to suggest that the immunogenesis ofCovid-19 could in some cases be the result of immune dysregulation. On the other hand,endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal,and hypothalamus). These disorders are autoimmune or linked to degeneration.The main objective is to assess the thyroid function (thyrotropic axis) as well as thecorticotropic adrenal function of patients who have had Copvid-19 pneumonia. Thesecondary objectives is to describe the pathophysiological mechanisms of pulmonary andvasculothrombotic involvement of Covid-19

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.