COVID-19 Clinical Trials and Expanded Access

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation. Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu. Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.

By using recent data on hospital attendance and COVID-19 laboratory tests, available within two NHS trusts in Nottingham and Cardiff we will enable the calculation of the risk of developing COVID-19 infection after attending an outpatient hospital appointment. This will assist in the restart planning when resuming face to face outpatient radiology appointment.

Severe Acute Respiratory Syndrome-Corona Virus-2 infection results in a mild infection in most of the patients. However, 15-20% require hospitalization, and among them, 15-20% will develop acute respiratory failure, leading to their admission in Intensive Care Unit. There are no accepted predictive criteria for aggravation. Severe forms of Coronavirus induced disease-19 (COVID-19) are the consequence of endotheliopathy, and hyperinflammatory and pro-coagulant state. The Triggering Receptor Expressed on Myeloid cells-1 (TREM-1) is an immunoreceptor that acts as an amplifier of the inflammatory response. TREM-1 is expressed on myeloid and endothelial cells. Its activation leads to endothelial activation and damage, hyperinflammatory, and pro-coagulant state. TREM-1 activation is associated with poor outcome during septic shock and myocardial infarction. We here aim at investigating the relationship between TREM-1 pathway activation and clinical degradation and outcome of COVID-19 hospitalized patients.

Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome. IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes

This is an open-label, interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate + SFC in subjects with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19) involving 40 subjects. The primary objective is to evaluate the safety of 4-week oral administration of 5-ALAPhosphate + SFC. This study is expected to last for 4 weeks and will include follow-up until day 28 in the hospital or in an outpatient setting if the subjects are discharged earlier.

This study objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies.

African American adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to COVID-19. This intervention involves a multi-disciplinary and culturally sensitive approach to address two major COVID-19 related challenges in this population. First, this program collaborates with predominantly African American churches to implement Federal and State guidelines aimed at preventing outbreaks of COVID-19 at faith-based gatherings. Second, this program trains church-based health advisors to help African American older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic.

The study is designed as an open observational non-comparative study of Polyoxidonium®, lyophilizate for solution for injections and topical application, 12 mg in hospitalized patients with coronavirus disease (COVID-19).

Lung ultrasound (LUS) has also been shown to be more accurate than chest x-ray in identifying pulmonary consolidation and pulmonary edema, both of which are found in patients with COVID. The investigators hypothesize implementation of LUS by hospitalists in the management of suspected or diagnosed patients with COVID-19 will reduce the need for Chest CT and chest x-ray, thereby conserving PPE, reducing risk of transmission to technicians and conserving the resources of radiology services that would otherwise be overwhelmed by patients with COVID-19 in need of chest imaging. Using the methods of implementation science, the investigators propose to respond to the urgent need for rapid implementation of LUS by hospitalists in management of adult patients hospitalized for COVID. Aim 1a: Using a rapid-cycle weekly Plan-Do-Study-Act cycle and Rapid Iterative RE-AIM, to optimize the implementation of LUS by adult hospitalists in the management of COVID-19 patients in a pilot study Aim 1b: Evaluate this pilot implementation of LUS by adult hospitalists using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.