COVID-19 Clinical Trials and Expanded Access

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.

The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is atwo-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib(RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatmentof COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patientsprogressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for14 days and will receive follow-up assessment at 7, 14 and 28 days after the first studydose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially,n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis toassess the efficacy and safety of the treatments, approximately n=285 (95 per arm) willbe recruited during Stage 2.

The non-essential and non-urgent follow-up consultations of patients living with HIV werepostponed or transformed into "teleconsultation" or exchanges of e-mails betweenpractitioners and patients during COVID-19 epidemic. This change in care can have animpact on follow-up and access to treatment for PVVIH.

This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded,age-escalating study to assess the safety, reactogenicity and immunogenicity of a SKSARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or withoutAS03 in healthy younger and older adults.

This is a prospective, multi-center, observational study that will enroll patientsreceiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidneytransplantation who will be vaccinated against COVID-19.

SUMMARY Rationale: Allied health professionals (i.e., dietitians, exercise therapists,physical therapists, occupational therapists and speech and language therapists) mightplay an important role in the recovery of patients with COVID-19 who experiencelimitations in daily physical functioning and participation. However, the evidence basefor allied healthcare in patients with COVID-19 has yet to be established. To facilitatecare for people recovering from COVID-19 and to establish this evidence base, the Dutchministry has created a temporary regulation for primary care allied healthcarespecifically for patients with COVID-19.Objective: This study is setup alongside the temporary regulation and aims to evaluatethe longitudinal recovery trajectories and related costs of patients who visited aprimary care allied healthcare professional for the management of severe symptoms andactivity limitations and/or participation restrictions related to COVID-19.Study design: Prospective cohort study. Study population: 1,315 adult patients recoveringfrom COVID-19 with severe symptoms and activity limitations and/or participationrestrictions, and who are referred to a primary care allied health professional by ageneral practitioner or medical specialist within four months of the start of the diseasewill be eligible for this study.Intervention (if applicable): Although the nature of this study is non-experimental, theallied healthcare intervention can be considered experimental due to the novelty of thedisease.Main study parameters/endpoints: The primary outcome domain of this study isparticipation measured with the Utrechtse Schaal voor Revalidatie - Participatie(USER-P). The primary endpoint is set at 6 months. A 5 point difference will beconsidered clinically relevant for patients with COVID-19.Nature and extent of the burden and risks associated with participation, benefit andgroup relatedness: There are no specific risks involved with participation in this study,as it entails the completion of questionnaires over the timeframe of one year (at thestart of the treatment, the end of the treatment, 3 months, 6 months, 9 months and 12months). The load of the survey will be highest at months 3, 6 and 12 with a total of 74survey items. Input from patient representatives suggested that this number of items wasfeasible, especially because participants are allowed to complete the survey over anumber of days. Finally, none of the items in the survey are considered emotionallydistressing. The prescribed interventions are conform the recommendations of the bestavailable evidence and are in line with usual allied healthcare interventions. Therefore,risks are likely to be negligible conform usual allied healthcare.

Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson mechanical ventilation.

This study investigates the well-being and health-related quality of life in cancerpatients and survivors during the COVID-19 pandemic. Using questionnaires may helpresearchers gain an understanding of how experiences during the COVID-19 pandemic (e.g.,exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss offamily or friends, loss of income), may impact multiple domains of health-related qualityof life (physical, emotional and social well-being), and other areas such asCOVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms),and disruptions to health care, finances, and social interactions.