COVID-19 Clinical Trials and Expanded Access

Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)pandemic has spread around the world. The people most exposed to this virus remain thehealthcare personnel who are on the front line in the fight against this pandemic. Due tothe delayed nature of the pandemic in Reunion island and its insular geographicalsituation, the study of the voluntary medical personnel will allow the investigators toestablish a longitudinal follow-up of the anomalies of the lipidic balance in relation tothe exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profilesare profoundly modified with very significant reductions in plasma cholesterol levels,LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles arealtered during viral infections, for example, the severity of dengue is inverselycorrelated with total cholesterol and LDL-C but not with HDL-C levels, according to arecent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteinsrich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptorclass B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the denguevirus and increase its infectivity by promoting its entry into cells, also via SRB1. Atthe moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. Theinvestigator hypothesize that a drop in plasma HDL-C levels and a change in their sizeduring infection could justify future therapeutic approaches aimed at supplementing thesubjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosapneumonia in mice, investigators have shown that the injection of reconstituted HDLallowed to limit the pulmonary inflammation and the deleterious consequences of theinfection. The investigator propose to study not only the lipid profiles in subjects whoare infected with SARS-CoV-2 but also the polymorphisms of genes involved in theregulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP)depending on the developed forms, symptomatic or not.

Randomized open label clinical trial carried out at study centers in Sweden, includingKarolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and VästmanlandsHospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligiblefor inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µgtwice daily or to standard of care. Primary outcome is duration of received supplementaloxygen therapy. Key secondary outcome is a composite outcome of death and receivedinvasive mechanical ventilation within 30 days.

The main objective of this multicenter cohort study is to determine the degree of COVID19infection immunization of a population of psychiatric patients.The secondary objective of this cohort follow-up is to: 1. Clinically characterize COVID patients who are positive for serological testing 2. Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis 3. Immunologically characterize COVID patients who are positive for serological testing 4. Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

Oslo University Hospital has initiated an observational study on hospitalised patientswith confirmed COVID-19, the infection caused by Severe Acute Respiratory SyndromeCoronavirus type 2 (SARS-CoV-2).

This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping inthe convalescence of COVID-19.

The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assesswhether a peer-led online support community can improve behavioral health outcomesrelated to COVID-19.

To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bonemarrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy hasan influence on the resolution processes in ARDS patients infected with Severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2).

The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity andmortality in over 170 countries. Increasing age and burden of cardiovascularcomorbidities are associated with a worse prognosis among patients with COVID-19. Inaddition, serologic markers of more severe disease including coagulation abnormalitiesand thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19infection and are more common in patients who died in-hospital. As the COVID-19 pandemiccontinues to grow, there is a pressing need to identify safe, effective, and widelyavailable therapies that can be scaled and rapidly incorporated into clinical practice.Understanding the putative mechanism of increased mortality risk associated with abnormalcoagulation function and cardiac injury is critical to guide studies of promisingtherapeutic interventions. Published and anecdotal reports indicate that endothelialdysfunction and thrombosis are common in critically ill patients with COVID-19, includingreports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys.Patients with cardiovascular disease (CVD) and CVD risk factors are known to haveendothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mLwas associated with an 18 times higher risk of in-hospital death, underscoring theimportance of increased coagulation activity as a potential modifiable risk marker thatmay drive end-organ injury. Given the established link between endothelial dysfunctionand thrombosis in patients with cardiovascular disease, and the association betweencoagulopathy and adverse outcomes in patients with sepsis, the association betweenincreased coagulation activity, end-organ injury, and mortality risk may represent amodifiable risk factor among COVID-19 patients with critical illness. Therefore, wepropose to conduct a randomized, open-label trial of therapeutic anticoagulation inCOVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety.

This retrospective study aims to perform a medication risk stratification using drugclaims data and to simulate the impact of the addition of various repurposed drugs on theMedication Risk Score (MRS) in a health insurance population. Our clinical tool wouldenable us to identify potential multi-drug interactions and potentially reduce the riskof adverse drug events (ADE) developing in these patients infected with COVID-19.

Prospective study evaluating the outcomes of implementation of a protective protocol forCovid-19 for patients and staff in a large endoscopy unit.