Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.
The information provided here is drawn from ClinicalTrials.gov. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.
Emergency INDs
To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.
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Displaying 220 of 379Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19). Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal
Roche Pharma AG
The investigators will follow a single prospective cohort of 50 Health Care Workers in the Hospital Italiano de Buenos Aires (Argentina) from May 15th to August 31st 2020 using antibody testing for SARS-CoV-2 IgM and IgG at baseline and every 2 weeks in order to assess the incidence of COVID-19, the prevalence of anti-SARS-CoV-2 antibodies (IgM and IgG) and incidence of reinfection or reactivations of previous COVID-19 using viral gene sequencing in this cohort.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged 18~59 Years.
Azienda Ospedaliera Universitaria Integrata Verona
The process by which neutrophils expel DNA together with various proteins to the outside, forming a network structure called Neutrophil Extracellular Traps (NETs) constitutes a particular cell death that involves the destruction of the nuclear membrane before the plasmatic one. This process is called NETosis and differs from other known forms of cell death, such as necrosis and apoptosis. This process, however, if exaggerated, brings local or systemic damage. Viruses are known for their ability to evade the body's immune response. Only recently has it been seen that they can act as triggers for NETosis process. In fact, many viruses can stimulate neutrophils to produce NETs. Virus-induced NETs can begin to circulate in an uncontrolled manner, leading to an extreme systemic response of the body with the production of immunocomplexes, cytokines, Interferon I etc. To date, there are no data in the literature on the role of NETs in Covid-19 infection, a viral infection that leads to highly lethal interstitial pneumonia and for which there is currently no vaccine or specific therapy. Advanced forms of Covid-19 are often characterized by hyperinflammation ("cytokine storm") with the development of an ARDS-like condition. Furthermore, reports of micro and macro thrombotic phenomena such as microangiopathy, pulmonary embolism (which has led to a careful evaluation procedure for antithrombotic prophylaxis and/or coagulation in Covid-19 patients) are increasingly frequent. The primary objective of the study is to understand if NETs can be implicated in the response to Covid-19 and by which mechanisms. Concrete therapeutic proposals could derive from the knowledge and enhancement of this form of innate immunity. To do this, it will be necessary to evaluate the activity of NETosis in Covid-19 patients and evaluate whether the clinical course of the disease (worsening vs healing) determines the degree of NETosis activity. Therefore, the association between mortality from Covid-19/survival and NETs activity will be studied. Secondary objectives concern the possibility of studying the associations among NETosis markers and blood inflammation markers and among NETosis markers and the onset of peripheral or deep vein thrombosis. Finally, the possibility that the plasma deriving from Covid-19 patients could trigger the NETosis process in vitro will be evaluated.
University of Cambridge
Cardiovascular involvement in coronavirus disease-2019 (COVID-19) encompasses a wide range of vascular and myocardial pathologies, including both acute and long-term sequelae. The MIIC-MI study aims to investigate mechanisms of cardiac injury in COVID-19 using multi-modality imaging and immunophenotyping to better understand the link with adverse patient outcomes.
Centre Hospitalier Universitaire Dijon
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%. Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.
Medical University of Graz
The aim of this study is to measure current affective symptoms and psychological distress in individuals with severe mental illness during the COVID-19 pandemic using an online questionnaire survey. In addition, this study aims at identifying individual beliefs, sleep quality, attitudes concerning the virus, the adherence to the measures, believing processes, and coping strategies/resilience patterns referring to COVID-19 in different study centers.
Federal University of Rio Grande do Sul
Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (SARS-CoV-2) that can progress to severe disease requiring hospitalization and oxygen support in around14% of the cases and 5% require admission in intensive care unit. The medium and long-term impact in survivors of severe COVID-19 on lung function, exercise capacity and health-related quality of life remains to be determined.
Magdalena Salcedo
This is a prospective study analyzing the development of humoral immune response against SARS-Cov-2 in patients with previous Covid19: the aim is to compare the incidence, titration and evolution of IgG an IgM in a prospective cohort of liver transplant patients surviving to the first wave of Covid19, in comparison to not inmmunossupressed patients.
University of Glasgow
The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ systems, including the cardiovascular system. There are documented associations between severity of disease and risk of death and To provide all the information required by review bodies and research information systems, we ask a number of specific questions. This section invites you to give an overview using language comprehensible to lay reviewers and members of the public. Please read the guidance notes for advice on this section. 5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer). The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart failure, pulmonary embolism and disseminated intravascular coagulation. It is thought that the mechanism of action of the virus involves binding to a host transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and immune cells and cause further damage. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis. This study aims to look closely at the health of the vascular system of patients after being treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study is essential so that clinicians treating patients with high blood pressure understand the impact of the condition and these hypertension medicines in the context of the current COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients currently prescribed these medications or who are newly diagnosed with hypertension.