COVID-19 Clinical Trials and Expanded Access

The outbreak of the SARS-CoV-2 pandemic may be considered a traumatic phenomenon. In a sample of subjects suffering from different psychiatric disorders, psychopathological status and Post-Traumatic Stress Disorder (PTSD) symptoms over time are assessed using specific psychometric scales. In a sample of healthy controls PTSD symptoms are evaluated by Impact of Event Scale Revised (IES-R) and compared to patients' scores. We hypothesize that a significant number of psychiatric outpatients have experienced a clinical psychopathological worsening and a greater prevalence of PTSD symptoms compared to the general population. The study of the potential psychopathological changes could represent a useful contribution to deepen the understanding of psychological consequences of the pandemic.

The Covid-19 Serum Study is a prospective case-control study in 1. kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after transplantation (TX) (POST-TX Covid-19 Serum Study) or 2. patients receiving kidney or liver transplantation after having had a SARS-CoV-2 infection (PRE-TX Covid-19 Serum Study) The aim of this study is to evaluate the development of de novo donor specific antibodies (dnDSA) in transplanted patients being hospitalized due to an infection with SARS-CoV-2 (POST-TX Covid-19 Serum Study) as well as in patients receiving kidney or liver transplantation after having had an infection with SARS-CoV-2 prior to transplantation (PRE-TX Covid-19 Serum Study). Further, the investigators will evaluate possible consequences of having had a SARS-CoV-2 infection prior or after liver or kidney transplantation with regard to graft survival and incidence of graft rejection episodes as well as SARS-CoV-2 specific antibody development after SARS-CoV-2 infection.

Many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. The extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute, post-acute and long-term. Rehabilitation is defined as "a set of interventions designed to reduce disability and optimize functioning in individuals with health conditions in interaction with their environment." Rehabilitation might very well be a key strategy to reduce the impact of COVID-19 on the health and function of people. A team work is needed to implement this programs which are essential in all phases to facilitate early discharge, but even more to support and empower patients.

The coronavirus disease 2019 (COVID-19) initially developed at the beginning of December 2019 in Whuan, Hubei province of China has spread all over the world. Beside the most common symptoms at onset of illness including fever, fatigue, dry cough, myalgia and dyspnoea, there are less common symptoms such as headache abdominal pain, diarrhoea, nausea and vomiting. The proportion of patients complaining gastrointestinal symptoms is variable between 3,4% and 17,0%. Interestingly, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) RNA has been reported to be detectable in 50% of patients' stool samples and in these patients around the 50% had diarrhoea. SARS-CoV2 transmission has been reported to be through droplets. However, mounting evidence indicates that SARS-CoV2 has a tropism for the gastrointestinal tract and is excreted with faeces. Accordingly, a faecal-oral route of transmission of the virus has been recently postulated. Indeed, SARS-CoV2 binds to host ACE 2 receptors (ACE2) to entry into cells which are abundantly expressed by intestinal epithelial cells and regulate intestinal inflammation. Taken together, this evidence could provide a rational basis for the development of gastrointestinal symptoms reported by COVID19 infected patients. Primary aim: to evaluate the prevalence and prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease Secondary aims 1. to evaluate long term consequences of COVID-19 on gastrointestinal symptoms 2. to evaluate long term consequences of COVID-19 on the development of post-infection irritable bowel syndrome (PI-IBS) 3. to evaluate long term consequences of COVID-19 on the development of post-infection dyspepsia 4. to assess the clinical and laboratory predictors (risk factors) of post-infection gastrointestinal symptom development

The purpose of this study was to conduct an epidemiological survey of the pediatric population via SARS CoV-2 IgG antibody testing in order to evaluate the incidence of asymptomatic infection and seropositivity among children and establish risk factors of infection and characterization of asymptomatic carriers. Additionally, among seropositive children, antibody titers will be explored in order to reach a better understanding of the relationship between immunity over time after different types of initial exposures. Methods Study Design and Population A prospective epidemiological survey was conducted in the Pediatric Emergency Department (ED) of the Shaare Zedek Medical Center, a tertiary medical center in Jerusalem, Israel, between October 2020 and January 2021. All patients presenting to the pediatric ED during the study period and requiring blood tests or and IV insertion for any clinical reason were considered eligible to participate in the study. The parents and/or legal guardians of these patients gave oral consent for an additional 1-3 ml of blood to be sent for Sars-CoV-2 antibody testing. In addition, all consenting parent/guardians filled out a comprehensive questionnaire regarding demographic background, past medical history, and specific Covid-19 details such as exposures to carriers, past PCR testing, symptoms etc. All patients with positive serology results were contacted by phone and updated of the test results. Laboratory testing All blood samples were collected in a clot-activator test tube. Initial testing was conducted using the Abbott SARS-CoV-2 IgG assay. A positive result was considered a value above 1.5 with 0.8 - 1.4 cosidered grayzone results. All positive and grayzone results were then retested in the DiaSoren LIAISON® SARS-CoV-2 S1/S2 IgG assay. Statistical Analysis Statistical analysis was conducted using SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. Clinical variables were analyzed using the Chi-squared test for categorical variables and the t-test for continuous variables. All statistical tests were two-way tests and P value of 5% or less was considered statistically significant.

This retrospective-prospective longitudinal observational study was designed to evaluate the role of bedside lung ultrasound per se and in association with hemogasanalysis parameters in predicting the severity of COVID-19 patients in the Emergency Departement (ED). Retrospective data regarding patients who presented at the ED of IRCCS San Raffaele Hospital from 10/11/2020, together with those acquired by the observation of patients who will access to the ED until 10/05/2021 will be collected, configuring a total enrollment period of 6 months. Clinical informations about patients' medical history will be recorded, with particular focus on the type and date of onset of the symptoms. The diagnostic and therapeutic strategy will be chosen according to the current standard of care. Results of bedside lung ultrasound, together with vital parameters, blood gas analysis, laboratory and other findings will be recorded. The primary outcome will be defined as patients' outcome at time of discharge from the ED, in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death). Secondary outcomes will be patients' prognosis 30 days after access to ED and the required intensity of care (eg need for non-invasive ventilation, oro-tracheal intubation).The follow-up 30 days after access to the ED will be evaluated by telephone survey or by consulting medical records.

In this monocentric, prospective and descriptive trial we want to evaluate the long-term consequences for patients treated for Covid-19. Covid patients who were hospitalized for min. 5 days either in a Covid-19 department or in intensive care unit will be followed-up for 8 weeks after hospital discharge. This is done via an innovative electronic platform in the home environment (UZA@home). On the one hand the quality of life, rehabilitation and reintegration of the patient will be evaluated and on the other hand the patient will be screened for various psychosocial aspects such as anxiety, depression and post-traumatic stress syndrome.

Investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.

The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients.

This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.