COVID-19 Clinical Trials and Expanded Access

Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) havedramatically impacted the lives of children/adolescents (children) and families. Theclosure of schools, social and recreational activities, and modifications to workenvironments has led to significant changes in the way children and families are working,living and socializing. Although the impact on the mental health of children and familieshas not been well researched, it is anticipated that already stressed children andfamilies with pre-COVID-19 mental health challenges are at significant risk fordeterioration in their mental health. As such, the implementation, and evaluation(specifically: feasibility, acceptability and barriers) of virtual-care interventions toalleviate child and family anxiety and enhance family functioning are critical.Virtual-care also optimizes health equity initiatives in reducing social, economic andenvironmental barriers to services that can improve or maintain mental health (WHO, 2017;MOHLTC, 2018).The current study will evaluate an adapted virtual-care cognitive behavioural therapy(CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base intreating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, andChorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting theefficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr,and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate thefeasibility, participation barriers related to social determinants of health (SDH) andacceptability of this virtual-care intervention in addressing mental health challengesassociated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Earlyevaluation of this virtual-care intervention will enable future scale-up of thisintervention during the post-pandemic recovery time-period and during subsequent COVID-19waves, if necessary.

One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems.Through cardiovascular imaging and biomarkers analyses this study aims to evaluatewhether COVID-19 infection results in heart injury. The investigators will alsoinvestigate which patients are at risk of heart injury as a result of COVID-19 and whyonly some patients suffer heart problems as a consequence of the infection. The studywill also assess multisystem involvement including the lungs and kidneys.

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.

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)".

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.

Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract.Protection of health care workers during surgery has been increased and some guidelinesadvocate for abandoning laparoscopy in COVID19 patients for fear of contamination,evenghtough this does not benefit the patient. However, Sars-Cov2 contamination riskduring visceral surgery remains unknown. Inadequate protection is unnecessary costful andcan be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travelthrough droplet and air during visceral surgery. 2) Laparoscopy, because of thepneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrantmore droplet contamination, which would justified increased protection.