COVID-19 Clinical Trials and Expanded Access

The Açaí trial will be testing if the açaí berry extract, a safe natural product withanti-inflammatory properties, can be used as a treatment option in adult patients withCOVID-19 in the community.

This is a randomized double-blind placebo-controlled Phase II trial of recombinant humandeoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients withCOVID-19 pneumonia.Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanicalventilation will be invited to participate in this study. Potential subjects will beidentified from medical record review or from direct contact with physicians.Investigators will check medical history and confirm eligibility. Informed consent willbe obtained from either the patient or designated healthcare proxy.60 subjects will be enrolled. After obtaining informed consent, patients will berandomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longerreceiving mechanical ventilation, whichever is sooner plus standard of care vs. placebonormal saline 2.5 ml plus standard of care.

Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibodytests to help develop methodologies which provide fast and accurate results. Infectionwith coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing forCOVID-19 is crucial to understand who is infected and therefore a risk to others byspreading the infection. RRI are currently carrying out the following tests:A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 inwhole blood, serum or plasma specimens helps to assess whether an individual haspreviously had the virus and is potentially immuneB. Polymerase Chain Reaction (PCR) testing using an established method to check foractive SARS-CoV-2 infections.C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) intheir workforce, as well as their families (including children) and visitors to theirsite.Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 includingincidence, prevalence, information on asymptomatic carriers and efficacy of vaccination.Furthermore, identifying individuals that are infected with SARS-CoV-2 has greatpotential to improve health outcomes by allowing infected individuals to seek the correctmedical treatment as well as self-isolate and reduce transmission.

In the United Kingdom, there are currently 138,000 confirmed patients with coronavirus,causing 18,738 deaths. Whilst the disease may be mild in the majority of patients, asignificant proportion of patients require intensive care therapy and a ventilator due tolung injury. In addition to lung injury/failure (acute respiratory distress syndrome(ARDS)), around 50% of patients admitted to intensive care develop acute kidney injury(AKI) (requiring advanced support via haemofiltration) and multi-organ failure.It is unclear why patients suffering from COVID-19 develop such severe lung injury(requiring life support or ventilation) or indeed why patients develop other organdysfunction such as kidney injury. The investigators hypothesis that this may due to anover-reaction of the immune system particularly in the lungs. This then results in therelease of various mediators and biological messengers which can be pushed into the bloodbloodstream (exacerbated by positive pressure generated by the ventilator). Thesemediators then travel, via the blood, to other organs such as the kidney where they causeinflammation and injury of cells, resulting in organ failure.The investigators would like to apply their well-established laboratory methods tofurther the scientific community's knowledge of this severe and deadly viral conditionand we hope that this would lead to the development of medication that would treat thisdeadly virus.

Primary care physicians face limited availability of therapeutic options for thetreatment of COVID-19 in the outpatient setting. Furthermore, monoclonal antibodies andantiviral therapies that are currently approved for use in the outpatient setting byHealth Canada have excluded pregnant women and older adults from their clinical trials,are contraindicated for many patients, and most are prohibited for use by pregnant women.Identification of a safe, COVID-19 outpatient therapeutic with 20-year safety recordremains urgently needed.

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.

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.

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