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 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.

The study investigates how the COVID-19 pandemic has impacted the psychological,financial, physical, and social well-being of adolescent and young adult (AYA) cancerpatients and survivors. AYA cancer survivors have inferior long-term survival compared tothe general population, and the negative impact of the global COVID-19 pandemic may beeven higher in this vulnerable group. The information gained from this study may providean opportunity to determine the self-reported COVID-19 specific psychological distress inAYA cancer survivors, and may lead to the development of a targeted intervention toimprove physical and psychosocial health for AYA cancer patients and survivors.

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

The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Humanmilk is the best form of infant nutrition providing significant protection against manyillnesses for term and preterm infants. When mothers of hospitalized infants are unableto supply their milk, the recommended supplement is human donor milk. The impact of apandemic on human milk banking is unknown. This study seeks to address this public healthissue. Donor milk will be collected from the Rogers Hixon Ontario Human Milk Bank atSinai Health System in Toronto. Samples will be analyzed for the COVID-19 virus specificnucleic acid and antibody in real-time and results will be immediately disseminated torelevant organizations to inform local, national and international guidelines surroundingdonor milk banking to protect the health of infants.

The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Humanmilk is the best form of infant nutrition providing significant protection against manyillnesses for term and preterm infants. The impact of a pandemic on breastfeeding isunknown. This study seeks to address this public health issue. Breastmilk will becollected from mothers positive for COVID-19. Samples will be analyzed for the COVID-19virus specific nucleic acid and antibody in real-time and results will be immediatelydisseminated to relevant organizations to inform local, national and internationalguidelines surrounding breastfeeding to protect the health of infants.

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part isan open-label, single-arm, dose-escalating study to evaluate the safety and explore thedose limiting toxicity and maximum tolerated dose of a human umbilical cord derivedmesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acuterespiratory distress syndrome (ARDS). Qualified subjects after the screening will bedivided into low, medium, or high dose groups to receive a single intravenous infusion ofBX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight,respectively. The Phase 2a part is a randomized, placebo-controlled, double-blindclinical trial examining the safety and biological effects of BX-U001 at the appropriatedose selected from phase 1 for severe COVID-19 pneumonia patients with the sameinclusion/exclusion criteria as the phase 1 part.

This study uses questionnaires to gain an understanding of how experiences during theCOVID-19 pandemic, regardless of COVID-19 status, may have impacted health-relatedquality of life (HRQOL) and other areas such as COVID-19-specific psychological distress,disruptions to health care, finances and social interactions in cancer patients. Thecoronavirus disease 2019 (COVID-19) is an infectious disease that is caused by the severeacute respiratory syndrome coronavirus 2 (SARS-CoV-2). The information learned from thisstudy will guide the development of psychosocial programs to improve patient care andoutcomes in cancer patients and survivors in the context of facing a global pandemic.

DESIGN Longitudinal prospective observational multicentre study.Primary objective:Understand the immune mechanisms driving COVID-19 disease in patients with a history oflung disease