COVID-19 Clinical Trials and Expanded Access

The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and isconsidered a biological disaster. With medical organizations and staff on the frontline,the investigators should conduct assessments, for the different tiers of medical staff,patients, and community residents, on the short- term psychological and mentaldisabilities or danger factors that they might have faced. As such, the investigators candesign and establish a set of evaluative indicators of the risks of biological disasters,and strategies to manage guide and cope, and internal/ external testing strategies. Thesework in guaranteeing quality and performance, and as such, establishing "Digital Platformfor Integrated Research of Coronavirus disease 2019 (COVID-19)".

Background:The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a globalthreat to people, communities, and health systems. Researchers are concerned about themental health effects of the pandemic. They want to learn more about how it is affectingpeople s alcohol use and problems, and how it may continue to affect them over time.Objective:To study the impact of the COVID-19 pandemic on alcohol use and consequences inindividuals across the spectrum of alcohol use and those with alcohol use disorder.Eligibility:Participants who have been screened under the NIAAA Screening, Assessment and ManagementProtocol (14-AA-0181)Design:Participants will complete a baseline survey by phone. It will ask about alcohol use,alcohol dependence, and stress. It covers 2 time periods: the 12 months before thepandemic started and the time since it started.Participants will get an ID code and a link to an online survey. They will complete theonline survey within a week of the phone survey.Participants will complete a series of online surveys over 24 months. For the first year,surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8weeks, and then every 1-2 months for the rest of the year. For the second year, surveyswill be completed every 6 months. Surveys will cover the following topics: - Alcohol use and its consequences - Other substance use - Stress - Impact of the COVID-19 pandemic - Pain - Physical health - Sleep - Quality of life.Because the course of the pandemic may change, the frequency of the surveys may change.Participation lasts 2 years.

Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as apandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpesregion (AURA), the epidemic began in February 2020 and the number of infected people isstill important. Between 15 and 20% of COVID-19 patients develop an acute respiratorydistress syndrome (ARDS) leading to their hospitalization in intensive care. Theirclinical progression can be rapidly harmful with the development of severe ARDSassociated with an increased risk of death.Preliminary data on the immune response of COVID-19 patients describe the induction of amoderate inflammatory response and the occurrence of major progressive lymphopenia overtime associated with potential immunosuppression. Up to 50% of secondary infections arereported in deceased COVID-19 patients. However, no prospective study has exhaustivelydescribed the kinetics of the immune response of COVID-19 patients in intensive care.The precise description of the immune response over time in adult patients with a proveninfection with the SARS-CoV-2 virus and the study of the relation between this responseand the increased risk of organ failure (severe ARDS), death or nosocomial infection willallow us to better understand the pathophysiology of the immune response induced byCOVID-19 in order to (i) identify new therapeutic strategies targeting the host responsein patients in intensive care (ii) to develop biological markers to stratify patients forfuture clinical trials evaluating these immunoadjuvant treatments in COVID-19.

1. Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait. 2. Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.

COVID-19 is highly infectious and transmission of the virus is thought to be similar tothat of influenza which can be transferred through droplets released when a personcoughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may bean important way to deliver treatments that could reduce the amount of a virus that ispresent in the nose and mouth. This also could mean that there is less virus available topass on to others. We want to see if the use of nose rinses and mouth washes usingPovidone-Iodine will reduce the the amount of virus in the nose and throat of people whohave tested positive for COVID-19 disease and also reduce the spread of infection withintheir household.

This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety andEfficacy of Imatinib for Hospitalized Adults with COVID-19

Routinely collected data will be used to assess the morbidity and mortality of cancerpatients following a positive COVID-19 infection.

Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is oneof the most effective ways to reduce the spread of COVID-19, but this key preventionintervention may have adverse consequences on older adults living at home. Screeningolder adults living at home and at risk for adverse consequences of physical and socialdistancing is, therefore, a priority in order to prevent their occurrence. ESOGER("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen therisk-levels for adverse consequences related to COVID-19 physical distancing and 2) tocontinue appropriate preventive interventions in older adults living at home includingfrail older patients and older community dwellers. Experience cumulated during the pasttwo weeks revealed that ESOGER could be improved, in order to be more effective andefficient for the prevention of adverse consequences related to COVID-19 physicaldistancing. This improvement is based on two key components: 1) Comments of MontrealESOGER users and 2) Analysis of data. Because at this time no information is saved andstored, there is a need to save and store ESOGER information and create the ESOGERdatabank.

This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dosecombination formulation for subcutaneous injection (PH FDC SC) administered at home by ahome health nursing provider for patients with human epidermal growth factor receptor2-positive (HER2+) breast cancer who have completed concurrent chemotherapy withpertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV)and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDCSC, or trastuzumab SC in the clinic. The main objective is to enable continuity of careduring the COVID-19 pandemic.This study will enroll approximately 200 patients in the United States.Participants with early or metastatic HER2+ breast cancer will be enrolled in this study.Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks andcontinue treatment unless early cessation is necessary due to disease recurrence, diseaseprogression, unacceptable toxicity, participant withdrawal of consent, or per physician'srecommendation. Participants with early HER2+ breast cancer will receive PH FDC SC tocomplete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, ortrastuzumab SC they received prior to enrolling in this study, unless early cessation isnecessary due to disease recurrence, disease progression, unacceptable toxicity,participant withdrawal of consent, or per physician's recommendation.A remote cardiac surveillance substudy will be optional for patients enrolled at selectsites.The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer arisk for this patient population.

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimedat understanding how symptoms of traumatic stress and resilience evolve over time in theUniversity of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019(COVID-19) pandemic. The study is being conducted concurrently with a UMN peer supportprogram called the MinnRAP program and will remotely administer quality of life andmental health surveys to healthcare workers before they start the MinnRAP program andthroughout their participation in the program.