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.
Search Tips
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 1600 of 1611Uniformed Services University of the Health Sciences
This is a multi-center, observational study that will enroll 1) patients with severe COVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2) patients (medical record data) that have been previously treated with the Seraph® 100 after the date of the EUA approval (17 April 2020), but before the date that the study is approved at the study site, and 3) a convenience sample of patients (medical record data) in a historical control group who were admitted to the ICU at participating sites with severe COVID-19 infection, meeting the EUA treatment criteria, but not treated with Seraph® 100 up to the time the PURIFY-OBS protocol is approved at the site
National Institutes of Health Clinical Center (CC)
Background: People who are recovering from COVID-19 may continue to have problems that affect their daily life. For instance, they might feel overly tired. Researchers want to learn if exercise can help people recover after COVID-19 infection. Objective: To study if participation in a rehabilitation exercise program can help people recovering from COVID-19. Eligibility: Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causes COVID-19), and are still having some symptoms. Design: Participants will have a medical history and physical exam. They will give blood and urine samples. They will have tests to measure heart and lung function. Their blood vessels will be assessed. Participants will have a computed tomography scan of the body. They will have an ultrasound of the muscles in their arms, legs, and chest. Participants will take a 6-minute walk test. They will take other balance and movement tests. Participants will walk on a treadmill while hooked up to a monitor. Then they will be interviewed. It will be audio-recorded. Participants will complete surveys about their symptoms and daily activities. Participants will take a smell test. For this, they will identify different smells. They will also have memory, attention, and mental functioning tests. Participants will wear an activity monitor on their wrist 24 hours a day. They will exercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30 minutes. They will attend education classes once a week for 10 weeks. Participants will be contacted by phone or email every 3 months for 1 year after they complete the exercise part of the study. They will wear an activity monitor for up to 2 weeks.
Institut National de la Santé Et de la Recherche Médicale, France
The purpose of this study is to analyze in depth the relationship of myeloid cell subpopulations during infection by Severe acute respiratory syndrome coronavirus 2 (SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytes and dendritic cells, each divided into subpopulations with different functions in immune defense and immune pathologies. The study is based on the following hypotheses: - Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors. - Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis. - Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy. - The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets. - Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.
Tourcoing Hospital
Several publications document the occurrence of symptoms that persist or occur late. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients. Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
Assistance Publique - Hôpitaux de Paris
The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return
Medialis Ltd.
Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)
Coronavirus Disease 2019 (COVID-19) is a newly emerged disease, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 pandemic is having a large impact on the mental and physical health of patients, yet data on the quality of life of post-COVID-19 patients is lacking. There are currently no post-COVID-19 specific measures for quality of life, particularly none which include the views of post-COVID-19 patients themselves. This observational study will recruit participants to contribute their preferences to the creation of a post-COVID-19 specific patient-reported measure on post-COVID-19 quality of life. Participants will be split into three groups: those who were not hospitalised; those who were hospitalised but not in intensive care units; and those who were hospitalised and in intensive care units. The creation of this measure will form phase 1 of the study, with 30-60 participants (10-20 in each group above) recruited to complete online surveys to find out their preferences of areas of life to include in such a measure. This will involve 3 online surveys, 1) to ask which areas of life they feel are impacted and how; 2) to find consensus about the areas to be included; 3) to weight the relevance of these areas in relation to each other. In phase 2 recruitment will open to additional participants and all participants will be asked to complete the finalised post-COVID-19 quality of life measure once a month for 12 months, aiming for a minimum of 100 participants at this stage. All participants will also be asked to complete a demographic questionnaire to inform the analysis of the data.
Centre Hospitalier Universitaire de la Réunion
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 the healthcare personnel who are on the front line in the fight against this pandemic. Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1. At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection. The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.
Centre Hospitalier Intercommunal Creteil
In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan, Hubei Province in the People's Republic of China. The disease spreads rapidly and the number of sick people is increasing. On January 3, 2020 a new virus of the coronavirus family is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhan and subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the World Health Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On 11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus 2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is a pandemic. As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with more than 16,000 deaths attributed to this virus. (Ref WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ). In France, the number of cases rose from 105 cases at the end of February to 19615 confirmed cases on March 24. (Source Public Health France). Most of the cases are adults. However, children are not completely spared and serious cases have been described. These severe cases can be respiratory or extra-respiratory (e.g. myocarditis). We also know that pediatric and adult cases differ in terms of clinical, biological and imaging findings, particularly chest CT scans. However, the description of paediatric pictures, especially severe forms and the involvement of children suffering from co-morbidities, remains poorly reported. Finally, the risk factors for serious cases in children remain largely unknown. This observatory aim to describe the clinical phenotypes of hospitalized pediatric patients with Covid19 in France, according to age groups. Moreover for a subgroup of patients, informations regarding the long covid will be reported.
Rutgers, 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.