COVID-19 Clinical Trials and Expanded Access

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.

OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection andanastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior toextracoprporeal resection and anastomosis, in terms of anastomotic leakage.BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary toinfection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced toadapt our surgical procedures in order to minimize exposure to the virus as much aspossible.Based on the recommendations in case of surgery in patients with highly contagious viraldiseases, the latest studies suggest minimally invasive accesses to minimize the risk ofcontagion. One of the proposed measures is the performance of intracorporeal anastomoses.Therefore, given the extensive experience of our center in minimally invasive surgery andstudies on the validation of intracorporeal anastomosis techniques in both laparoscopicsurgery of the right colon and rectum (TaTME), and the study of advantages that they canprovide to the patient, our intention is to apply it to surgery on the left colon, sigmaand upper rectum. Our hypothesis is that exteriorization of the colon through anaccessory incision increases the risk of tension at the mesocolon level, thus increasingthe risk of vascular deficit at the level of the staple area and it may increase the rateof anastomotic leakage. In this sense, studies that validate a standard technique ofintracorporeal anastomosis in left colon surgery and that demonstrate its benefit withrespect to extracorporeal anastomosis are lacking. We intend to describe a newintracorporeal anastomosis technique (ICA) that is feasible and safe for the patient andthat can be applied universally. Once the ICA technique is established, it will allow usto determine its non-inferiority compared to the standard technique performed up to nowwith extracorporeal anastomosis.METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinomawill be included into a prospective cohort and treated by laparoscopy with totallyintracorporeal resection and anastomosis. They will be compared with a retrospectivecohort of consecutive patients of identical characteristics treated by laparoscopy withextracorporeal resection and anastomosis, in the immediate chronological period.

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 Phase 2/3 trial evaluates four treatment strategies for non-critically illhospitalized participants (not requiring ICU admission and/or mechanical ventilation)with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir withor without Dexamethasone.

This is a European observational cohort study (data research) involving multiple centresto look at the potential impact of COVID infection on patients with rare skin diseasesexamining factors such as comorbidity, protection factors, and clinical and/ortherapeutic factors. The data collected may provide additional information on thesituation of patients and, on a wider basis, provide useful data applicable to thegeneral population.

There is a lack of knowledge about how many children are infected with SARS-CoV-2, howoften they are asymptomatic, and how long the immunity persists.The main purpose of this study is to measure antibodies to SARS-CoV-2, symptoms, and riskfactors in a representative cohort of children and adolescents in the canton of Zurich,Switzerland, shortly after re-opening of the school system and thereafter. The study alsoinvestigates antibodies to SARS-CoV-2 in parents of the children and school personnel.

The objective of our study is to evaluate safety, tolerability, and immunogenicity ofCOVID-19 preventive DNA vaccine in healthy volunteers.