COVID-19 Clinical Trials and Expanded Access

The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economicand mental-health challenges, especially for vulnerable populations such as pregnant andpost-partum females. In this study, we aimed to evaluate the relations between the fearof COVID-19 and postnatal depression symptoms.

Study population: Patients with fibrotic lung sequelae after recovery from acute phase ofsevere COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administeredfor 24 weeks in patients who have pulmonary fibrotic changes after suffering severeCOVID19 pneumonia, analysed by - % change in forced vital capacity (FVC) - % fibrosis in high resolution computed tomography (HRCT) of the lung

Phase 2 ,double blind, randomized study of therapy with Angiotensin 1-7 in COVID-19patients. 120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinicalsymptoms including dyspnea, cough and fever, hospitalized in the KETER department inseveral hospitals in Israel, will be enrolled. 60 patients will receive Ang 1-7subcutaneously 500 mcg/kg /day. 60 patients will receive placebo : NaCl 0.9% 2 ml-control arm .Treatment duration: 14 days or until clinical improvement that enables discharge fromhospital.(the shortest time will be the limiting factor in treatment duration). Follow-up-30 days.14-30 days after discharge from hospital: we will contact the patient via phone to askquestions related to any possible adverse reaction to the drug and general health.

COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic byspreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-likeillness with expected recovery. According to World Health Organization, the overallglobal case fatality rate is currently estimated to be 2.9%. However, patients havingsevere or critical illness presenting with severe respiratory distress, ARDS or shocksuffer most with mortality rates of 49.0-61.5%. Studies suggest that there are mild orsevere cytokine storms in severe patients, which is an important cause of death. Anexaggerated and uncontrolled release of pro-inflammatory mediators by an overly activatedimmune system is known as cytokine storms (CS) or cytokine release syndrome (CRS) whichhas an important role in the hemodynamic insults seen in very ill COVID-19 patients. Thisaberrant release of pro-inflammatory cytokines causes lung damage, myocarditis, acutekidney injury, etc. In this study, the investigators aim to estimate the burden ofcytokines and their correlation with the magnitude of the severity of COVID-19 illness inBangladeshi adults.

The principal objective is to determine the impact of phenelzine on the activationphenotype of T cells and myeloid cells during SARS-CoV2 infection

The recent and unexpected occurrence of patients with the development of skin lesions onthe hands and/ or feet has been described recently. As these cases occurredcontemporaneously with the Coronavirus Disease 2019 (COVID-19) and as it was the mostoften occurrence of de novo frostbites, the question raised of whether there is a directlink between the occurrence of these lesions and infection of the severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) the responsible for CoVID-19. Indeed,mechanisms of these lesions and the precise correlation with Sars-CoV-2 remains poorlyunderstood. Therefore, this study aim to: 1. Determine the possible link with this virus, 2. Understand the mechanisms involved in the pathogenesis of these lesions.

Detection of the incidence and types of arrhythmia and conduction block in COVID - 19patients Detection and description of CMR patterns of myocardial injury in COVID-19patients with arrhythmias.

The investigators are enrolling 100 healthcare Provider volunteers (n=100) from acrossthe United States to help to evaluate and document the financial impact of COVID-19 onPhysicians and other healthcare Providers. This investigation will compare individualPhysician revenues before and after the advent of the COVID-19 pandemic. Theinvestigators expect to be able to differentiate between revenues lost due to theCOVID-19-driven business recession and revenues lost due to the manipulation ofreimbursement processes by insurance companies. The inextricable linkage between Payerand Physician revenues suggests that Payer revenues are higher at the direct expense ofPhysicians, since both streams come from the same sources of funding. The secondaryobjective is aimed at revealing the methods Payers use to retain more money.

The outbreak of coronavirus disease 2019 (COVID-19), caused by infection of SARS-CoV-2,has rapidly spread to become a worldwide pandemic. Global research focused on theunderstanding of the biochemical infective mechanism and on the discovery of a fast,sensitive and cheap diagnostic tool, able to discriminate the current and past SARS-CoV-2infections from a minimal invasive biofluid. The fast diagnosis of COVID-19 isfundamental in order to limit and isolate the positive cases, decreasing with a promptintervention the infection spreading.The aim of the project is to characterize and validate the salivary Raman fingerprint ofCOVID-19, understanding the principal biomolecules involved in the differences betweenthe three experimental groups: 1) healthy subjects, 2) COVID-19 patients and 3) subjectswith a past infection by COVID-19. The large amount of Raman data will be used to createa salivary Raman database, associating each data with the relative clinical datacollected.Starting from the preliminary results and protocols of the Laboratory of Nanomedicine andClinical Biophotonics (LABION) - IRCCS Fondazione Don Gnocchi Milano, the salivacollected from each experimental group will be analysed using Raman spectroscopy. All thedata will be processed for the baseline, shift and normalization in order to homogenizethe signals collected and creating in this way the Raman database. The average spectrumcalculated from each group will be characterized, identifying the principal families ofbiological molecules responsible for the spectral differences.EXPECTED RESULTS: Verify the possibility to use Raman spectroscopy on saliva samples forthe identification of subjects affected by COVID-19. The principal aim of the project isto create a classification model able to: discriminate COVID-19 current and pastinfection, identify the principal biological molecules altered in saliva during theinfection, predict the clinical course of newly diagnosed COVID-19 patients, translationand application of the classification model to a portable Raman for the test of a pointof care.

In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,wasidentified as the culprit of this disease currently being identified as "CoronavirusDisease 2019" (COVID-19) by World Health Organization.Coronavirus was found to not only target the patient's lungs but also multiple organs.Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms.Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) wasfound in patient's feces, suggesting that the virus can spread through feces. In ourprevious study, stool samples from 15 patients with COVID-19 were analysed. Depletedsymbionts and gut dysbiosis were noted even after patients were detected negative ofSARS-CoV-2. A series of microbiota were correlated inversely with the disease severityand virus load. Gut microbiota could play a role in modulating host immune response andpotentially influence disease severity and outcomes.The investigators are uncertain about the impact of synbiotic on patients with COVID-19.However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patientswith COVID-9 who take synbiotic or not, leading to lesser progression to severe disease,less hospital stay and improved quality of life.