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.
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.
To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.Displaying 10 of 513
Groupe Hospitalier de la Rochelle Ré Aunis, Numa Health International
During this pandemic period, the goal of the health care system is to optimize the use of intensive care services for patients infected with SARS-CoV-2, given the frequency of complications that can lead to high mortality. When patients with suspected or confirmed Covid-19 are admitted to hospital, whether or not they are symptomatic, there is currently no method to predict who will progress to complications requiring the use of intensive measures in 24-48 hours.
This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
Assistance Publique Hopitaux De Marseille, Innate Pharma
The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).
Fuzhou General Hospital
Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019
The outbreak of coronavirus disease 2019 (COVID-19) at the end of 2019 has seen numerous patients experiencing severe acute lung injury (ALI), which developed into severe respiratory distress syndrome (ARDS). The mortality was as high as 20% -40%. Due to the lack of effective antiviral treatments, supporting treatment is the predominant therapy for COVID-19 pneumonia. Its cure is essentially dependent on the patient's immunity. While the immune system eliminates the virus, numerous inflammatory cytokines are produced and a cytokine storm occurs in severe cases. Mesenchymal stem cells (MSCs) play an important role in injury repair and immune regulation, showing advantageous prospects in the treatment of COVID-19 pneumonia. MSCs prevent cytokine storms by retarding the TNF-α pathway, alleviate sepsis by modulating macrophages, neutrophils, NK cells, DC cells, T lymphocytes and B lymphocytes. After infused, MSCs aggregate in the lungs, improve the lung microenvironment, protect alveolar epithelia, and improve pulmonary fibrosis and pulmonary function.
London Ambulance Service NHS Trust, London School of Hygiene and Tropical Medicine
COVID-19 presents a significant and unprecedented public health challenge which is placing enormous strain on global health services. In London, we have seen exponential growth in the number of cases of COVID-19 and significant public concern which has been felt across healthcare systems. The London Ambulance Service NHS Trust (LAS) is consistently experiencing its busiest days on record and is at the frontline of the response to COVID-19. Whilst knowledge of the progression and clinical manifestations of the disease is improving, there is a lack of knowledge of how COVID-19 patients access and use emergency medical services (EMS), and what interventions are required to manage these patients in their prehospital phase. This knowledge is vital for the planning and delivery of EMS care as the pandemic develops. Similarly, although evidence is emerging from the in-hospital setting about the toll of caring for COVID-19 patients, little is known about the effects on the mental wellbeing of EMS staff who are faced with considerable uncertainty when triaging, assessing and treating patients with limited access to support, resources or testing. This mixed method study will have two parallel work packages: Work package one will aim to rapidly improve knowledge of how patients with COVID-19 access and use EMS services. Patient records will be reviewed for patients who present to LAS and go on to receive a diagnosis of COVID-19. Characteristics and trends in these presentations will be reported to inform the ongoing planning and delivery of EMS care to these patients. Work package two will explore, through questionnaires and interviews, the personal and professional impacts of triaging, assessing and treating patients who receive a diagnosis of COVID-19. This will inform the ongoing support requirements for EMS staff and provide evidence to support the planning for future pandemic disease outbreaks.
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional substudy to explore the long-term sequelae of resolved COVID-19 pneumonia.
Istituto Auxologico Italiano
Predictors of Cardiovascular Risk in Covid-19 Patients During Acute Disease and at Short Term Follow-up
Northern Italy, and particularly Lombardy, is one of the regions of the world mostly affected by COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To investigate the still largely unknown pathophysiology of this disease, we have built a consortium of Italian Hospitals to include a large cohort of COVID-19 patients from mild out-patients managed by GPs to inpatients developing mild, moderate or severe disease assessed both in hospital and at a 3-6 month follow-up visit). Consortium partners have a wide expertise to allow for 1) comprehensive assessment of risk factors for severe COVID-19 syndrome; 2) study the pathophysiology of its cardio-respiratory manifestations; 3) estimate risk scores also with artificial intelligence and 4) assess its clinical immunoinflammatory and cardiorespiratory sequelae in discharged patients at short term follow-up. To this aim, we will 1. Enroll around 5500 COVID-19 patients (1000 outpatients and 4500 in-patients), which will allow to: 1.1 Phenotype patients with COVID-19 of variable severity 1.2 Assess the prevalence of COVID-19 among GPs in relation with their use of PPE 1.3 Evaluate the impact of patients' demographic and clinical characteristics COVID-19 severity 2. Use an electronic CRF (on RedCap) to record clinical, biohumoral and imaging data of inpatients with COVID-19 of various severity to explore the prognostic and pathophysiological role of immunologic factors, activation of blood coagulation, endothelial dysfunction, inflammatory response, genetic (ni particular X-linked), hormonal and metabolic factors, comorbidities and acute cardiac damage. Blood samples will be collected. We will also use machine learning techniques to develop multivariable models for patients' risk stratification 3. A follow-up visit at 3-6 months after discharge will be performed to identify residual clinical consequences that might affect long-term prognosis.
Erasme University Hospital, Université Libre de Bruxelles, King Baudouin Foundation
Study of Resilience and Loneliness in Youth (18 - 25 Years Old) During the COVID-19 Pandemic Lock-down Measures.
The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries. This online survey assesses these measures implications on Mental Health in emerging adults. The questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental Health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during Lock-down Measures. At least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the SARS-CoV2 Pandemic Lock-down Measures.
University Hospital, Toulouse
This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units. The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units. This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.
The unprecedented confinement and social distancing rules imposed by the fight against COVID-19 has forced the majority of the population worldwide to stay home for periods of time ranging from weeks to months. Eating habits are undoubtedly perturbed during this period, with consequential impact on food security. Therefore, the primary aim of this NutriQuébec sub-study is to document the impacts of the COVID-19 pandemic on diet quality and food insecurity of adults in the province of Québec in Canada. NutriQuébec is a web-based prospective cohort study launched in June 2019 whose primary aim is to provide data for the evaluation of the Government Health Prevention Policy on the Québec population's eating habits over the years (NCT04140071). Participants of NutriQuébec are invited to complete on a web-based platform nine core questionnaires on a yearly basis. Questionnaires assess several dimensions related to lifestyle, including eating habits and physical activity habits, as well as a large number of personal characteristics and global health status. For the purpose of this sub-study, NutriQuebec will invite the 2465 active participants who completed the first-year questionnaires prior to the COVID-19 pandemic to fill out again those questionnaires during the peak period of the confinement period in April and May, 2020. This NutriQuébec sub-study will provide invaluable data on how the COVID-19 pandemic impacts diet quality and food insecurity of adults in the province of Québec.