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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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 174Direction Centrale du Service de Santé des Armées
Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress). The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes. The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response. The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context. The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.
University Hospital, Strasbourg, France
North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.
M.D. Anderson Cancer Center
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
Instituto de Medicina Regenerativa
This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment.
Deborah O'Connor
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. When mothers of hospitalized infants are unable to supply their milk, the recommended supplement is human donor milk. The impact of a pandemic on human milk banking is unknown. This study seeks to address this public health issue. Donor milk will be collected from the Rogers Hixon Ontario Human Milk Bank at Sinai Health System in Toronto. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding donor milk banking to protect the health of infants.
Deborah O'Connor
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown. This study seeks to address this public health issue. Breastmilk will be collected from mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding breastfeeding to protect the health of infants.
Oslo University Hospital
This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by COVID-19.
Baylx Inc.
This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.
Notitia Biotechnologies Company
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.
National Cancer Institute (NCI)
This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.