COVID-19 Clinical Trials and Expanded Access

The current COVID-19 pandemic is the biggest global healthcare challenge in the last century, and the number of cases in the next 12 months is likely to increase. There is currently no proven treatment, chemoprophylaxis or vaccine against COVID-19, which exhibits a wide clinical spectrum from asymptomatic carriage to mild upper respiratory tract infection, severe viral pneumonia to acute respiratory distress syndrome and death. Key workers are at high risk of exposure highlighting the need for effective preventative strategies. SARS-CoV-2 is a positive-sense single-stranded enveloped RNA virus which transmits via droplets, aerosols and direct contact, to reach their target naso- and oropharyngeal epithelial cells through initial electrostatic interactions to cell surface heparan sulphate (HS) proteoglycans. Carrageenan mimics cell surface HS, thereby trapping the virus to allow mucociliary clearance and has demonstrated anti-viral activity in-vitro and in a number of common cold clinical trials when administered as a nasal spray. ICE-COVID a randomised, double blind, placebo-controlled phase III trial of the prophylactic efficacy of iota-carrageenan nasal and throat spray in preventing COVID-19 illness in at risk healthcare professionals. Participants (n=240) will be randomly allocated to either the treatment arm (verum Coldamaris plus, 0.12% iota-carrageenan plus 0.04% Kappa-Carrageenan in 0.5% saline) or placebo (Coldamaris sine, saline 0.5%) arm. The study's primary objective is the prevention of COVID-19 infection, confirmed by PCR swab or documented seroconversion. Secondary objectives are to determine if carrageenan sprays reduce the clinical severity of COVID-19 and symptomatic acute respiratory infection of other aetiologies (non-SARS-CoV-2).

The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an ongoing basis, depending on the results of their evaluation.

The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.

The biomarker soluble urokinase plasminogen activator receptor (suPAR) is the soluble form of the cell membrane-bound protein urokinase plasminogen activator receptor (uPAR), which is expressed mainly on immune cells, endothelial cells, and smooth muscle cells. SPARCOL is a multi-center prospective observational study aiming to investigate if suPAR measured at admission can predict the risk of future complications and mortality in adults patients with Covid-19. The study will include approximately 500 patients and will be one of the largest so far. The study has been registered at Clinical Trials.gov and has been approved by the Institutional Review Board of the University Hospital of Larisa. Consecutive adult patients (≥ 18 years ) who are admitted to the Hospital due to Covid-19 will be screened for inclusion. Participants will undergo sampling of peripheral venous blood, immediately after admission. Blood samples drawn from all patients and EDTA plasma will be stored at -80° C until later measurement. Plasma suPAR levels will be determined using the suPARnostic® ELISA assay (ViroGates, Denmark). The primary endpoint will be the presence of respiratory complications, admission to ICU, and survival at 30 days. Secondary endpoints are also included, such as organ injury, hospital length of stay, and survival. Data analysis will be based on predefined data points on a prospective data collection form.

This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.

Ultrasounds are usually done by a specially trained health professional in the hospital or emergency department (ED) setting. Using a novel single-probe device, the ultrasound can be plugged into an iOS / Android device. The purpose of this research is to assess the usefulness of lung ultrasound imaging, performed by the patient in the home setting for the management of the COVID-19 disease using this novel highly-portable ultrasound.

Acute Respiratory Distress syndrome (ARDS) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. COVID-19 evokes a viral pneumonia, which may result in ARDS as well. It is not yet clear if COVID-19 disease behaves like the typical ARDS. Corona virus causes primarily deep hypoxia. Hypoxia, on its own, can lead to long term cognitive impairment. However, critical illness also affects long-term neurocognitive functioning. The investigators will be researching the possibility of long-term cognitive impairment in COVID-19 ICU patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.

The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants. Blood tests will be done to check how much HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation may include up to ten visits to the study center.

Since 2000, various emerging infectious diseases have repeatedly caused serious impact on the health of the global population and the healthcare systems. With the growing international transportation and improving accessibility of the healthcare systems, hospitals have been inevitably the first sentinels dealing with emerging infectious diseases. The biological disasters, such as the Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East Respiratory Syndrome (MERS) outbreak in South Korean in 2015, and the Coronavirus disease 2019 (COVID-19) outbreak this year, challenged our vulnerable healthcare systems and caused great loss of lives. Regarding the ongoing global epidemics and possible community outbreaks of the COVID-19, the management of biological disasters for an overcrowded emergency department should be planned. In the early 2020, the emergency department used a double-triage and telemedicine method to treat non-critical patient with suspected COVID-19. This application reduced the exposure time of the first responders and reserve adequate interview quality. However, for the critical patients treated in the isolated resuscitation rooms, the unique environment limited the teamwork and communication for the resuscitation team. These factors might led to poorer quality of critical care. The investigators designed a telemedicine-teamwork model, which connected the isolation room, prepare room and nursing station by an video-conferencing system in the emergency department. This model try to break the barriers of space between the rooms and facilitate the teamwork communications between each unit. Besides, by providing a more efficient workflow, this model could lower the total exposure time for all workers in the contaminated area. This study was conducted to evaluate the benefits of the telemedicine-teamwork model and provide a practical, safe and effective alternative to critical care of the patients with suspected highly infectious diseases.

AIM: We propose an innovative approach using Lifelight® smart technology that will enable the continued provision of high level patient care at the same time as reducing pressure on nursing and equipment resources. METHOD : Lifelight® is a computer program ("app") which can be used on smart devices that contain a camera. It is able to measure all of the vital signs by measuring very small changes in skin colour that occur each time the heart beats. This means that it does not need to touch the patient. We believe this could be an effective way of measuring vital signs, especially during the COVID-19 pandemic when prevention of cross-contamination between patients is essential. Patients are also likely to be reassured by a contactless approach. During this study, we will recruit two groups of people who are hospitalised with an acute illness. The first group will be people expected to have abnormal blood oxygen levels such as those with acute respiratory problems including those with COVID-19. The second group will be people expected to have abnormal blood pressure. These Lifelight vital signs will be compared to measurements from standard clinical equipment. The exact number of participants recruited will depend on how quickly the app "learns" and how many of the vital signs collected are outside of the normal range. For the first group of participants, we will use a camera to collect data about the changes in their face and use this to teach the app how to measure blood oxygen level and also to check how well the app measures blood oxygen level, heart rate and respiratory rate. For the second group of participants, we will use a camera to collect data about the changes in their face to check how well the app measures blood pressure and respiratory rate. All of the data will be kept secure and participants will not be able to be identified.