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 50 of 1213Karyopharm Therapeutics Inc
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.
Apices Soluciones S.L.
COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.
Hamad Medical Corporation
Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Hope Biosciences
Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
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.
Neuroganics LLC
The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigen tests, like Turklab Test-It COVID-19 Home Test, AllBio Science Inc. and Artron Laboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 after diagnosis with COVID-19 or following vaccination to measure the onset and time course of detectable antibodies from finger-stick blood drops and rapid antibody lateral flow tests. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support and provide evidence of antibody time-course response to vaccination.
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, Angers
The outbreak linked to SARS-CoV-2 infection was declared a Public Health Emergency of International Concern on 30 January 2020. In all of the emergency Departments, a major reorganization was necessary, notably with the creation of a specific channel for COVID-19 suspect patients. Thus, all caregivers involved must adapt day by day to new places of exercise, new protocols,...The major influx of patients, the precautions to be taken, the specifics of the pathology and its management have profoundly changed daily practice. This exogenous hospital tension impacts all caregivers and more particularly their resilience capacities. Resilience is defined as an ability to recover from or adjust easily to misfortune or change. The Resi-CoV study aims to assess the level of resilience of caregivers of different specialties and trades in the context of covid-19.
Central Hospital, Nancy, France
Different studies have demonstrated that the absence of companionship during labor and childbirth may be responsible for a negative birth experience, an increased risk of postnatal depression and/or post traumatic stress disorders. These situation may also have a negative impact on mother-child interaction, on marital and family relationship and on the rate of maternal suicide in postpartum. However, these previous results cannot be extrapolated in the current context where the absence of the companionship is imposed by the confinement framework. The objective of the CONFINE study is to assess, for the first time, the birth experience of women in the context of limited social support in the immediate post-partum period due to confinement, as well as the associated over-risk of mental disorders, compared to a post-partum without social restriction.
University Hospital, Lille
Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration. In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression. During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients. The present study is an "emergency" being realize before the end of the quarantine.