COVID-19 Clinical Trials and Expanded Access

The project is an observational, prospective study. Its aim is to deepen ourunderstanding of COVID-19 in older patients hospitalized and diagnosed with COVID-19.In particular, socioeconomic, diagnostic, biological, functional, therapy data will becollected at the patients' admission, during hospital stay, at the discharge and 1, 3, 6,12 months after discharge.Results and findings will help support changes in clinical practice and decision making,with the aim to reduce the use of healthcare services and the healthcare expenditure.

The study aims to investigate the efficacy of extracorporeal CO2 removal for correctionof hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distresssyndrome

Efficacy of Ivermectin in larger doses in COVID-19 treatment

The study investigators are interested in learning more about how drugs, that are givento children by their health care provider, act in the bodies of children and young adultsin hopes to find the most safe and effective dose for children. The primary objective ofthis study is to evaluate the PK of understudied drugs currently being administered tochildren per SOC as prescribed by their treating provider.

Since the outbreak of a syndrome of acute respiratory distress associated to a novelcoronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitaryemergency with critically care support when the patient evolves to an acute respiratorydistress (ARDS). In the context of supply shortages (ventilators, bed capacities) thatcountries have to deal with, data were lacking of characteristics and outcomes ofpatients admitted to intensive care unit (ICU). the purpose of this project is to reportthe epidemiology and the outcomes of a French cohort of critically ill patients withSARS-Cov2

RACONA is a prospective trial that will test the hypothesis that nafamostat can lowerlung function deterioration and need for intensive care admission in COVID-19 patients.Design: Adult hospitalized COVID-19 patients will be randomized in a prospectivedouble-blind randomized placebo-controlled study to test the clinical efficacy ofnafamostat mesylate (administered intravenously) on top of best standard of care.Primary outcome measures: the time-to-clinical improvement, defined as the time fromrandomization to an improvement of two points (from the status at randomization) on aseven category ordinal scale or live discharge from the hospital, whichever comes first.

LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also knownas novel coronavirus or COVID-19) who have recovered from acute infection. The study isdesigned to provide a specimen bank of samples with carefully characterized clinicaldata. LIINC specimens will be used to examine multiple questions involving the virologic,immunologic, and host factors involved in COVID-19, with a focus on understandingvariability in the long-term immune response between individuals.

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, isshed in the stools of patients who are infected.

Emergent experimental and anecdotal evidence has indicated that critically ill COVID-19patients demonstrate two patient sub-types (called phenotypes). In one group the diseaseprogresses slowly and patients have a low potential of developing mild respiratoryfailure, but in the other group, an exaggerated immune response(hyper-inflammation/cytokine storm) may be linked to the onset of precipitous respiratoryfailure, termed acute respiratory distress syndrome. This syndrome is responsible for alarge portion of COVID-19 associated mortality. Thus, determining links betweenhyper-inflammation and acute respiratory distress syndrome in COVID-19 patients is ofimmediate importance. Blood samples will undergo a number of analyses to help us tounderstand as much as possible about COVID-19. We will also study any differences inphysiologic and cytokine levels before and after patients are treated withimmunomodulatory therapies as part of clinical care in COVID-19 patients.

The etiological agent of the current pandemic is a (+)ssRNA virus. SARS-CoV-2 isinfecting thousands of people in the world with a fatality rate that varies from 0.1 to5% in affected countries, thereby causing enormous economic losses. Few antibiotics haveshown any efficacy in their combat, but have not yet proven adequate to stop the spreadof the disease, nor are there any approved vaccines at the moment. From experiments inplants ongoing infections by RNA viruses, using thermotherapy, which is the applicationof heat at a temperature between 35-43 °C, the investigators know that raising thetemperature affects the transcription of viral proteins due to the formation of small RNAmolecules that interrupt the replication process by grouping in specific regions of theRNA molecule, preventing and inhibiting transcription. These small molecules are calledsmall interfering RNAs (siRNAs). This feature has been used through thermotherapy inhumans to combat the rapid replication of cells (i.e. cancer cells), attack cellsinfected by RNA viruses, and in the treatment of some parasitic infections.There arevarious commercially available devices for thermotherapy use in humans; they are mainlybeing used to ease muscle pain. They work by increasing the temperature in the rangerecommended for thermotherapy in humans 39-43 ° C. Therefore, the investigators considerthis treatment modality can be used to aid in the elimination of SARS-CoV-2 from thehuman body, decreasing viral load, which could allow the immune system time for itscontrol and elimination.