COVID-19 Clinical Trials and Expanded Access

: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developedSAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc]bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluatethe safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participantswith COVID-19.

Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2could result in endothelial dysfunction with increased risk of arterial thrombotic eventsby downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelialfunction can be easily and non-invasively determined by carotid artery reactivity (CAR)testing.Objective: To investigate the predictive value of endothelial dysfunction, measured bycarotid artery reactivity testing, for 1-year cardiovascular events in patients with pastCOVID-19 infection.Study design: A prospective observational longitudinal cohort study.Study population: Patients recovered from confirmed infection with SARS-CoV2.Main study parameters/endpoints: macrovascular endothelial function measured by carotidartery reactivity testing.

Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2Coronavirus, poses an increasing threat to individual health and health care systems. Theindividual disease course ranges from mild to life threatening, the pandemic spread leadsto a shortage of health care resources including intensive care availability. It shouldbe the overarching goal to allocate sparse health care resources to those most at needand to simultaneously avoid unnecessary blocking of resources by clinically unjustifiedhospitalizations.Individuals with preexisting cardiovascular conditions are at the highest risk of healthdeterioration, even at younger age. Objective criteria for hospitalization are notimmediately available in a outpatient settings. Hence, hospitalization and emergencymedical contact is often triggered by subjectively interpreted symptoms. The goal of thisproject is thus to improve the availability of objective measurements in the outpatientsetting by means of an innovative, smartwatch mediated telemedicine approach.To achieve this goal, the investigators will conduct a randomized clinical trialcomparing a smartwatch based telemedicine intervention with standard of care. Theintervention group will receive regular objective measurements of heart rate, ECG, andSpO2 and will get access to a 24/7 medical care hotline for consultation. Theinvestigators hypothesize that the intervention group will benefit by a significantreduction in unnecessary hospitalizations and unplanned emergency medicine contacts.

The primary purpose of this study is to gain an understanding of how experiences duringthe COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domainsof health-related quality of life and other areas such as COVID-19 specific psychologicaldistress, and disruptions to health care, finances and social interactions. We will alsoevaluate the extent to which resiliency factors such as social support, perceivedbenefits under times of stress, and ability to manage stress may buffer associationsbetween COVID-19 experiences and HRQoL. To meet these objectives, we have developed a10-minute questionnaire that taps into these areas and is based on prior work addressingconcerns of other pandemics or national crises. Participants will have previouslyconsented to protocol PA15-0336 and have provided prior lifestyle data. This will allowus to connect the COVID-19 survey data with prior existing data.

The study will follow COVID-19 patients who required intensive care after 3-6 months andone year after discharge from the ICU with functional level as well as organ function toassess recovery after COVID-19. Blood and urine will be collected for biobanking.

The purpose of this research study is 1) to conduct a prospective longitudinalsurveillance research trial, enrolling up to 200 CCHMC employees as they come back towork, and then following their clinical and laboratory parameters for up to 12 months;and 2) to support the ongoing development of diagnostic techniques for COVID-19. Theoverall goal is to investigate patterns of SARS-COV-2 infection, including immunologicalrecovery and genetic risk factors, among CCHMC employees to better understand how tosafely reintroduce the CCHMC work force back into their normal routines.

The COVID-19 crisis began in China in December 2019 and was declared a pandemic by theWorld Health Organisation on March 11th 2020. The pandemic has changed the way thatclinicians interact with and treat patients overnight. Staff within the NHS will be underhigh levels of stress due to the increased needs and worse outcomes of work as they areshielding or self-isolating and may feel helpless and guilty. The psychological impact ofthe pandemic will be prolonged and varied. It is vital that Investigators increaseunderstanding as much as possible to support NHS staff.The aim of this survey is to examine the possible mental health burden on NHS staff as aresult of the COVID-19 pandemic and how these change as the pandemic progresses. Byunderstanding these effects, it will allow researchers to identify recommendations toallow support mechanisms to be put in place for NHS staff, to better manage this andfuture pandemics and similar crises.Investigators are aiming to sample several cohorts of NHS staff including a subset ofstaff who are shielding. Staff will be asked to complete a series of online surveys atmultiple timepoint: on study initiation, 1 month later and then 3 months after thepandemic has ceased in the UK. Additional timepoints may be added depending on the lengthand severity of the pandemic.The main outcomes will be tracking changes in mental health measurements at thepre-defined timepoints. This work will allow Investigators to produce recommendationsabout the increased mental health support that NHS staff will need. If a need isdemonstrated then an interventional research project will be designed and implemented.

This is a prospective, randomized, single-center, open-label controlled trial, designedto compare the efficacy of two ventilation strategies (Low Tidal Volume and positiveend-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS)Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versusLow Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducingdaily lung injury score in patients with acute respiratory distress syndrome caused byCOVID-19. The two strategies incorporate different prioritizations of clinical variables.The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requirestolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stressprotection, avoiding alveolar overdistension and collapse.

To respond to the COVID-19 pandemic, investigators will be deploying community healthworkers, equipped with mobile technology, and accompanied by youth to visit householdsdoor to door to screen for symptoms of COVID-19, isolate, test, and manage suspectedcases of COVID-19. The community health workers and youth will educate households aboutpreventive measures including frequent handwashing and home management of mild cases.Simultaneously, investigators will work with nurses, doctors, and clinical officers, totest and treat more severe cases of COVID-19 in health facilities. Our goals are: tovisit every household in Siaya county covering a population of close to 1 million, and totrain and support health workers working in 32 health facilities with oxygen capacity inSiaya to reduce the morbidity and mortality related to COVID19 and other conditions.

The purpose of this study is to analyze in depth the relationship of myeloid cellsubpopulations during infection by Severe acute respiratory syndrome coronavirus 2(SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytesand dendritic cells, each divided into subpopulations with different functions in immunedefense and immune pathologies.The study is based on the following hypotheses: - Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors. - Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis. - Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy. - The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets. - Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.