Clinical Trials and Expanded Access

Immunotherapy based on Adoptive Cellular Transfer (ACT) uses several types of immune cells, including dendritic cells, cytotoxic T lymphocytes, lymphokine-activated killer cells, and NK cells. NK cell-based immunotherapies are an attractive approach for treating diseases because of their characteristic recognition and killing mechanisms; they are involved in the early defense against infectious pathogens and against MHC class-I-negative or -low-expressing targets without the requirement for prior immune sensitization of the host and are able to lyse target through the release of perforin and granzymes and using antibody-dependent cellular cytotoxicity pathways mediated by Fc receptor for IgG (CD16). The aim of this project is to evaluate the safety and immunogenicity of allogeneic NK cells from peripheral blood mononuclear cells (PBMCs) of healthy donors in patients infected with COVID-19 collected by apheresis. This allows us to collect cGMP PBMCs and immunomagnetic remove several types of undesirable cells including B, T and CD33+ cells with enrichment of NK cells that will be expanded in bioreactors with GMP culture media (AIM-V) supplemented with human AB serum and GMP grade IL-2, and IL-15. After quality control verification the final NK cell product will be resuspended in 300 mL saline solution for intravenous infusion. Initially, we will enroll in this study ten COVID-19 infected adult patients with moderate symptoms (NEWS 2 scale score>4). Consent forms will be signed by the patient before the therapy. Patients will be treated with three different infusions of NK cells 48 h apart with 1, 10, and 20 million cells/kg body weight. We will follow the patients for any adverse effect, clinical response and immune effects by flow cytometry including markers for NK cells expressing different markers (CD158b, NKG2A, and IFN-y). We anticipated that the release of IFN-y by exogenous NK cells could attract other immune cell populations to boost the immune response against COVID-19.

This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).

Comparing the efficacy and safety of adjuvant use of Ivermectin in covid19 patients with pneumonia using Ivermectin with hydroxychloroquine compared to HCQ

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.

The Coronavirus Emergency has severely affected Italian Healthcare National System. This event made it necessary to adopt extraordinary containment measures and to allocate extraordinary resources in Italian hospitals. In many centers routinely elective surgical activity has been decreased or even completely abolished. We believe that this exceptional condition is being consequently having a significant impact on surgical training programs.

The actual pandemic infection related to SARS-CoV2 results in viral pneumonitis (COVID-19), that may, in the more severe cases, lead the patients to the intensive care unit (ICU). The more frequent presentation is acute respiratory distress syndrome (ARDS). To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor. ACE2 belong to the renin-angiotensin-aldosteron system (SRAA), and ACE2 levels are directly modified when SRAA inhibitors are administred to patients, and ACE2 level increases particularely with Angiotensin II Receptor blockers (ARA2) use. The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU). COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.

Documentation of all patients undergoing inpatient treatment for SARS-CoV-2 infection with regard to clinical status at admission, medical history, inpatient treatment and course of disease. The aim is to create a risk stratification of the infection on the basis of clinical data as well as therapy and disease progression of the patients. This may also contribute to a better planning of resources.

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for these fragile populations. The only source of residual social ties during a period of confinement remains dematerialised communication via the various existing communication channels (in particular telephone calls or video telephony). As soon as the COVID-19 crisis began and the first visiting restrictions were imposed on patients in the geriatric department of the Angers Univesity Hospital and the Retirement Home / long-term care unit, acute care geriatric unit of Angers offered patients and residents the opportunity to organize communication with their relatives via videophone calls. Initial feedback from the field shows us that, contrary to our intuition, patients and residents are not necessarily asking for communication to the outside world and, when they are, the preferred channel is not necessarily video telephony but often a simple phone call with relatives. Even though the vast majority of projects aimed at setting up communication aids for the elderly now rely on videophonic support, these initial observations in everyday care situations raise questions about the directions taken in this area. Also, the investigators ask themselves the following question: in the absence of a physical meeting, what is the preferred means of communication for elderly people in isolation in hospital or in Retirement Home? This study will make it possible to propose the most appropriate solutions for breaking isolation for the hospitalized or institutionalized geriatric population in order to limit as much as possible the increase in social isolation imposed by restrictions on movement during epidemics.