COVID-19 Clinical Trials and Expanded Access

During this pandemic period, the goal of the health care system is to optimize the use of intensive care services for patients infected with SARS-CoV-2, given the frequency of complications that can lead to high mortality. When patients with suspected or confirmed Covid-19 are admitted to hospital, whether or not they are symptomatic, there is currently no method to predict who will progress to complications requiring the use of intensive measures in 24-48 hours.

Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19

Covid-19 infection is an on-going pandemic with worse diagnosis in adults with comorbid conditions such as hypertension and cardiopulmonary diseases. Obstructive sleep apnea (OSA) is common in those comorbidities and may contribute to worse prognosis for the Covid-19 cases.

This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada. Phase I of this study will determine the best route for the swabs (nasal, throat, or both), and to determine if this POC test results are comparable to the standard core-lab test results.

The purpose of this research is to collect information about coronavirus exposures, symptoms, and health care visits due to the among Atrium Health clients and health care workers. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.

The patients enrolled in this study will be all patients entering triage with suspicion of SARS-CoV2. Planned activities are required by the nasopharyngeal swab in parallel with the analysis of the conjunctival swab to identify new potential alternative and equally effective diagnostic pathways. Simultaneously systemic data (as Pulmonary images, hematological parameters etc.) will be collected to observe a possible correlation between conjunctival swab positivity and systemic impairment.

The COVID-19 disease has been subject to numerous publications since its emergence. Almost 20% of people suffering from COVID-19 develop severe to critical symptoms and require hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is the main reason for admission in ICU of these patients. Therapeutic strategies implemented for the management of critically-ill patients may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead to long-term disabilities expressing trough dependence and quality of life impairment of survivors. The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose. Ancillary studies aim to assess the course of muscle function (atrophy, structural modifications), lung function (loss of aeration) and safety of early mobilization.

The purpose of this study is to investigate the impact of COVID -19 in the cancer patient population. This will be done by looking at the rate of asymptomatic COVID-19 infection in cancer patients receiving cancer therapy, as well as their immune response. This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network (UHN) and other centers.

During the COVID-19 pandemic several countries have seen a high risk of transmission for health care personnel, with some countries having as many 20-25% of nurses and doctors either infected or showing symptoms of COVID-19. In this prospective cohort study, we will systematically screen all hospital staff in the Capital Region of Denmark for IgM and IgG antibodies against SARS-CoV-2 using a point of care tests and an Elisa kit. Testing will be offered 3 times: In April 2020, Maj 2020 and September 2020. All participants will submit a questionnaire regarding exposures, risk factors and symptoms of COVID-19 in relation to each testing. Follow-up will be through electronic patient records and national registries. We will compare the group of health care personnel with data from a control group of healthy volunteer blood donors from the Danish Blood Donor Study. The aim of the study is to investigate the proportion of hospital staff with SARS-CoV-2 antibodies during the study period compared to a control group representing the Danish population. We will compare the test characteristics of the two methods of testing, a point of care test and Elisa. Further, we will investigate the extent to which prior immunization or infection is protective for future infection with COVID-19.

Doctors, nurses and staff members of ear-nose and throat (ENT) departments are at high risk due to aerosol-inducing diagnostic procedures and surgery during the COVID-19 epidemic. Reports from China, Spain, Italy and England report of fatal cases among ENT specialists. With a concurrent lack of personal protection, it is of paramount importance to identify patients and healthcare workers at an early stage to prevent a COVID-19 outbreak in the department. A baseline study of all healthcare workers has been performed. Follow-up will be accomplished by interval testing, antibody measurements and REDcap Covid-19 questionnaires. All patients at risk of carrying SARS-CoV-2, or who are candidates for high-risk airway surgery will be tested. Infection control measures at the department will be implemented progressively according to the real-time surveillance results from both patients and healthcare workers.