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 1220 of 1251Rutgers, The State University of New Jersey
Our long-term goal is to protect the health care workforce (HCW) caring for SARS-CoV-2-infected patients, their families, communities, and the general population. Our specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system. We addressed this hypothesis by recruiting and longitudinally following 546 HCW and a comparison group of 283 non-HCW within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a several year period (2020-2024) and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at multiple time points, we will uniquely characterize SARS-CoV-2 transmission and risk factors for COVID-19 among HCW and our larger academic community.
University Hospital, Bordeaux
The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization. In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline. The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.
University Hospital of Ferrara
The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes
University of Manchester
A team at the University of Manchester are developing a test that tcould be helpful in detecting immunity to the Coronavirus (which causes the COVID-19 disease) in participants with inflammatory arthritis. It is based on a flu assay has already developed; the team will replace the flu antigen with a Coronavirus antigen to see if it is effective. This project aims to develop a test to see if people who have had the virus have developed immunity to it. This could help to predict who might or might not get the disease a second time, who should stay at home to be protected from potential infection or who will not develop any symptoms, even if exposed to the virus. When vaccination trials against the Coronavirus will be launched, this test could also help to see if the vaccine is effective.
Columbia University
The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.
Centre Hospitalier Universitaire de Besancon
SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. COV-CREM is a French prospective monocentric study that will evaluate viral-specific cell responses in positive patients for SARS-CoV-2 on the basis of (RT-PCR) assay performed in respiratory tract sample tested by our local Center for Disease Control.
Methodist Health System
This is a prospective cohort observational registry study that will include data on all patients who are treated at MHS facilities for COVID-19.
University of Edinburgh
COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no currently approved treatment other than supportive care. Urgent investigation of potential treatments for this condition is required. This protocol describes an overarching and adaptive trial designed to provide safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients receiving normal standard of care. Given the spectrum of clinical disease, community based infected patients or hospitalised patients can be included. Products requiring parenteral administration will only be investigated in hospitalised patients. Patients will be divided into cohorts, a) community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation. Participants may be recruited from all three of these cohorts, depending on the experimental therapy, its route of administration and mechanism of action. The relevant cohort(s) for any given therapy will be detailed in the therapy-specific appendix. Candidate therapies can be added to the protocol and previous candidates removed from further investigation as evidence emerges. The trial will be monitored by an independent Data Monitoring Committee (DMC) to ensure patient safety. Each candidate cohort will include a small cohort of patients randomised to candidate therapy or existing standard of care management dependent on disease stage at entry. Cohort numbers will be defined in the protocol appendices. This is a Phase IIa experimental medicine trial and as such formal sample size calculations are not appropriate.
City of Hope Medical Center
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.
Milton S. Hershey Medical Center
Nursing homes are ground zero for the COVID-19 pandemic. Nursing homes are ill-equipped for the pandemic; though facilities are required to have infection control staff, only 3% have taken a basic infection control course. Significant research has focused on infection control in the acute care setting. However, little is known about the implementation of practices and effective interventions in long-term care facilities.The investigators propose an intervention utilizing Project ECHO, an evidence-based telehealth model, to connect Penn State University experts with remote nursing home staff and administrators to proactively support evidence-based infection control guideline implementation. Our study seeks to answer the critical research question of how evidence-based infection control guidelines can be implemented effectively in nursing homes