COVID-19 Clinical Trials and Expanded Access

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.

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 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.