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 20 of 523University College Hospital Galway
Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE
Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.
Ludwig Boltzmann Institute for Lung Health
Summary of the study Study population: A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD) Potential output and analysis: - Extent of age-specific infection and antibody formation - Cumulative incidence of infection - Rate of asymptomatic infection - Relationship with socioeconomics, lifestyle and risk factors (comorbidities) Study design: Prospective, longitudinal, stratified by age and gender Duration of study: Initial testing as soon as possible and repeat based on monitoring of the pandemic curve (probably after 2-3 months) Information to be obtained from participants: - serum samples for information on SARS-CoV2 infection and antibody formation - data on clinical symptoms
William Beaumont Hospitals
The purpose of this study is to determine how peoples' bodies respond to exposure to COVID-19. Employees of Beaumont Health in Michigan who are older than 18 years may be eligible to participate. Participants from other high-risk groups who are not Beaumont employees may also be recruited, as may family members of Beaumont employees who have tested positive for COVID-19. Participants will have blood drawn two or more times for serology testing. This serology test will determine if participants have detectable levels of the antibodies that our bodies develop to fight COVID-19 infection. Participants will fill out a questionnaire each time they provide a blood sample. The questionnaires include questions about participants' personal traits; their health; general questions about their risk to exposure; job and risk of exposure; symptoms, diagnosis, treatment of COVID-19 since last blood draw. Researchers will monitor participants' medical records in a confidential manner for one year after the last blood draw to help determine if people who develop antibodies to COVID-19 are protected against developing a COVID-19 infection in the future.There may be no direct benefits for participants; however, information from this study may benefit other people by increasing our understanding of COVID-19, how it spreads from person to person, and how people respond to fight off the infection.The results of the serology test are used for research only and will not affect clinical decisions regarding participants' treatment or quarantine
Duke University
This current proposal evaluates the Longitudinal Energy Expenditure and Metabolic Effects in Patients with COVID-19 (LEEP-COVID) to understand, guide and optimize our metabolic and nutritional care of these high risk patients. As no data exist for the metabolic effects of COVID-19 patients, this data is urgently needed and essential to assist in the care of COVID-19 patients worldwide. We are uniquely positioned at Duke to perform this research, as we are the only US center with 2 of the FDA-approved devices in existence currently capable of collecting this vital data to guide the care of COVID-19 patients worldwide.
Assaf-Harofeh Medical Center
The 2019-20 coronavirus disease, caused by COVID-19, is an ongoing pandemic. The measures in which public health officials quarantine confirmed and isolate symptomatic cases in order to reduce the spread COVID-19 is the common practice used in most countries. However, a significant question remains in regards to the asymptomatically infected individuals, which may propagate the virus and impede infection control. The other question to consider is whether these asymptomatic carriers develop an immune response or continue viral shedding. The purpose of the current study is the evaluate the immune response, i.e developing anti-SARS-CoV-2 antibodies in the asymptomatic cases, in a household study design. We plan to evaluate over 1000 patients with positive COVID-19 results and their households.
Medical University of Graz
The aim of our study is to observe the intensive care course in 30-50 COVID-19 patients with regard to cardiovascular risk factors and biomarkers. The primary objective of this study is to investigate the cardiovascular risk and its impact on cardiovascular complications in COVID-19 patients in intensive care units. This study is designed to investigate correlations and to investigate factors influencing the course of the new viral disease COVID-19 in intensive care. Previous scientific findings are still rare due to the relevance of the disease, therefore this study is also explorative and not exclusively based on a hypothesis. The cardiovascular risk will be assessed upon admission to the intensive care unit and subsequently the course of biomarkers (see below) will be analysed in a cohort study (no, low and high cardiovascular risk).
University Hospital Plymouth NHS Trust
This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.
St. Joseph's Healthcare Hamilton
The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.
Jena University Hospital
The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.
Università degli Studi dell'Insubria
The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program. The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100. The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis. Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available. The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).